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Pci jobs in Rockford, IL - 39 jobs

  • Warehouse Coordinator (Shipping)

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Title: Warehouse Coordinator (Shipping) Location: Assembly Drive, Rockford, IL 61109 Shift: 3rd shift Summary of Objective: Seeking a detail-oriented and organized Warehouse Coordinator to join our warehouse team. The Warehouse Coordinator will play a crucial role in managing, analyzing, and ensuring the efficient flow of materials within the warehouse. This role is responsible for inventory accuracy, forecasting material needs, and collaborating closely with warehouse staff, offsite warehouse, and other departments to support production schedules and ensure timely order fulfillment. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Inventory Management & Analysis * Monitor and maintain optimal inventory levels by analyzing usage trends and demand forecasts. * Conduct regular material staging audits to ensure inventory accuracy. * Material Planning & Forecasting * Collaborate with offsite warehouse and production teams to forecast material requirements based on production schedules and customer demands. * Use data-driven insights to support material requisitions and reduce stockouts or overstock situations. * Develop and maintain material planning and replenishment strategies, adjusting as necessary to meet operational needs. Data Reporting & Documentation * Document and analyze material movements, identifying areas for process improvements. * Track key performance indicators (KPIs) related to inventory accuracy, and offsite warehouse efficiency. Collaboration with Stakeholders * Coordinate with warehouse, and production partners to ensure timely delivery of materials and resolve any issues affecting material availability. * Work closely with warehouse staff to streamline processes for material delivery, storage, and distribution. * Communicate effectively with production and operations teams to align on material needs and ensure seamless workflow. Process Improvement * Analyze warehouse workflows and material handling processes, identifying opportunities for efficiency gains and cost savings. * Implement best practices for materials management and contribute to the development of standard operating procedures (SOPs). * Participate in continuous improvement initiatives, such as Lean and Six Sigma projects, to enhance operational efficiency and accuracy. Strong analytical and problem-solving abilities. * Excellent organizational skills and attention to detail. * Effective communication skills, both written and verbal. * Ability to work independently and collaboratively in a fast-paced environment. * Adaptability to evolving warehouse technology and systems. * Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time. * Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear 3/4 of the day and up. * Work is primarily performed at a desk and/or in an office environment. 3/4 of the day and up. The noise level in the work environment is typically, moderate. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: * High School Diploma and/or 3-5 years related experience and/or training. * Basic Mathematical Skills * Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables. Preferred: * Ability to display excellent time management skills. * Ability to display a willingness to make decisions. * Ability to demonstrate attention to detail. * Ability to identify and resolve problems in a timely manner. * Ability to handle multiple demands and work under pressure. * Ability to work efficiently in a fast-paced environment. * Ability to input data into computer utilizing JDE systems. * Ability to be flexible and to adapt to changing conditions quickly. * Ability to implement process improvement initiatives. For candidates in Illinois: The hiring rate for this position is $19.96 to $22.46 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and 401(k). Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $20-22.5 hourly 6d ago
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  • Logistics Delivery Specialist

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Title: Logistics Delivery Specialist Location: Linden 2 South, Rockford, IL 61109 Shift: 2nd Shift - Monday - Thursday - 5pm - 3am Summary of Objective: The function of this position is to move material to and from the plants and to and from the offsite warehouse utilizing a tractor and trailer CDL (A) and to move and spot trailers in the yards for loading and unloading as required. This includes following all DOT regulations for pre-trip and post-trip inspections, moving materials and trailers as requested, and loading and unloading the trailers with a forklift. This position will also be responsible for completing inventory forms and inventory transactions in JDE, using barcode scanners for inventory control, investigating inventory discrepancies, assist Engineering with equipment movement, responsible for ensuring all logistical cGMP regulations are met and adhered to, and other duties as assigned. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned. Fully understand how to operate and safely drive your assigned vehicle. Drive trucks with a Gross Vehicle Weight (GVW) over 26,000 lbs. Safely and efficiently handle and unload goods at the destinations. Communicate with the plant and warehouse to ensure timely movement Confirm the contents of each load match the move sheets. Perform inspections of your vehicle before and after each trip. Always ensure the equipment is kept clean. Maintain and service vehicles as needed. Notify managers of any major maintenance or transport issues encountered. Adhere to company rules and regulations. Obey all applicable traffic laws and drive according to the weather/road conditions. Make safety a priority at all times. Communicate effectively with all levels of the organization. Complete inventory forms and inventory transactions in JDE. Use barcode scanners for inventory control. Investigate inventory discrepancies. Assist Engineering with equipment movement. Responsible for ensuring all logistical cGMP regulations are met and adhered to. Maintain compliance with warehouse records and log books. Perform forklift battery maintenance functions by checking water levels, charging batteries, and changing batteries in the forklift trucks. This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules. Attendance at work is an essential function of this position. Performs other duties as assigned by Manager/Supervisor. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: * Skills testing requirements met at the approved grade level for the position. * Basic Mathematical Skills * Basic Computer Skills: Ability to perform basic computer tasks and operate common computer programs. * Limited Working Proficiency: The ability to satisfy routine social demands and limited work requirements. The ability to read simple prose, in a form equivalent to typescript or printing, on subjects within a familiar context. * Basic Reasoning: Ability to apply common sense understanding to carry out uninvolved written or oral instructions. Ability to deal with problems that involve only a few concrete variables in standardized situations. * Valid Class A driver's license required * Clean driving record with no moving violations * Skilled at driving large vehicles * Comfortable maneuvering and parking a tractor-trailer * Alert, focused, and detail-oriented * Physically and mentally fit * Ability to lift up to 50 lbs. at a time * Able to operate an electric lift, hand trucks, pallet jacks, etc. * Disciplined, dependable, and resourceful Preferred: 2+ years of proven experience with tractor-trailer driving preferred Ability to display excellent time management skills. Ability to display a willingness to make decisions. Ability to demonstrate attention to detail. Ability to identify and resolve problems promptly. For candidates in Illinois: The hiring rate for this position is $19.96 to $24.46 hourly, plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k). #LI-KH1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $20-24.5 hourly 30d ago
  • Lead, Operations Training

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. 3rd shift: Job Title: Lead, Operations Training Department/Group: Production Location: Assembly Summary of Objective: This position is required to work cooperatively with production leadership to uphold high standards for excellence and proper cGMP practices for packaging products, from beginning to end, according to quality and safety compliance, and customer specifications. This position will be the first introduction to the production floor processes and standards, and will need to have the ability to maintain strict performance expectations as defined in current PCI best practice documentation. Creation and revision of best practice training materials will also be an essential function of this role. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. * Validate and certify the technical capabilities of production line personnel in accordance with the current standardized best practices, defined in company SOPs, Work Instructions, and batch record specifications. * Responsible for ensuring production line personnel are certified to the latest certification standards and established best practices. * Provide onboarding classroom instruction and training for new hire production floor personnel. * Integral team member for changes to current processes and implementations of new equipment. * Prepares, updates and distributes appropriate training materials in coordination with production/training leadership. * Actively rotate and train on the floor to stay current with processes and maintain certifications. * Audit compliance and strictly uphold high standards of excellence during and after training/certification process. * Monitor training progression of individuals, and work closely with production management/supervisors to schedule training certifications. * Provide clear and constructive feedback to OJT trainers based on observations during certification. * Escalate all quality, service, and equipment performance issues to supervision. Promote and maintain a safe work environment. * Support 5S throughout the facility. * Ensure compliance to company policies and documented best practices. Maintain high levels of cGMP compliance and expect that all 5s principles are followed including material flow and min/max expectations. * Facilitate and drive prompt completion of company mandated and role specific Compliance Wire trainings. * Participate in regular feedback sessions and progress reviews with managers for continuous training process improvement. * Participate in all required professional development courses offered. * Perform other duties as assigned by Manager/Supervisor. * Attendance to work is an essential function of this position. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: * Must be a minimum of Level 2 Line Leader to apply. * Consistent high performance in production floor processes and the use of current technology. * Basic Mathematical Skills * Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs. Proficiency in Microsoft Office Suite preferred. * Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. * Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations. Preferred: * Ability to follow instructions and respond to management direction. * Ability to work independently and/or part of a team. * Ability to adapt to changing work environments. * Ability to demonstrate attention to detail. For candidates in Illinois: The hiring rate for this position is $19.96-$22.46 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $20-22.5 hourly 60d+ ago
  • Accounting Controller

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Summary: This position will direct staff and manage all accounting activities to ensure compliance with generally accepted accounting principles, corporate policies, and external audits. In this position you will be responsible for all accounting functions to include but not limited to payroll, accounts payable, accounts receivable, and the monthly closing and preparation of reports in support of all financial statements. You will report to and work closely with the Executive Finance Director ("EFD"), the corporate accounting function and other stakeholders in the organization. This position requires strategic financial leadership, operational partnership, and compliance oversight in a dynamic, profitable, and growth-oriented environment. Key Responsibilities: * You will be responsible for all aspects of accounting (payroll, accounts payable, accounts receivable, billing, general ledger, fixed assets, audit, etc.). * Direct and supervise a team of people and proactively manage and coach the team providing employee development opportunities. * Manage and deliver timely monthly financial close process, including preparing journal entries, ensuring all costs incurred are properly recorded, perform account balance reconciliations and report preparation. * Oversee variance analysis and review expenses by financial statement line item for reasonability, investigate unusual amounts, make any corrections as necessary, and determine root cause and solutions. * Interact at all levels and with budget owners or other stakeholders to produce timely, efficient and accurate month-end close and all internal management and financial reporting incl. lease accounting. * Participate in the ongoing development & establishment of accounting policies and procedures and operational strategies including the review and implementation of process and system changes. * Drive continuous process improvements leveraging digital technology and support the development and enhancement of the ERP platform (JDE) to ensure systems integrity, financial effectiveness and controls. * Collaborate with external auditors to ensure successful audit results and compliance. * Define and maintain department KPI's. * Ensure compliance with internal control policies. * Assist with compilation of information for preparation of tax returns. * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. * Performs other duties and corporate finance projects as assigned by Manager. Knowledge, Skills and Abilities: * Relevant accounting experience in Manufacturing and/or Supply Chain. * Apply GAAP accounting standards related to revenue recognition, lease accounting and asset capitalization. * Experience with accounting software JDE or similar ERP platform is a plus. * Ability to quickly comprehend a complex organizational structure, including the general ledger structure and various financial systems, is essential. * Proven ability to leverage current technology to drive process efficiency and improve accuracy * Advanced analytical skills in combination with excellent written and oral communication skills. * Exceptionally well organized, flexible and easily adaptable to changing conditions. * Ability to work under pressure, meet deadlines and manage conflicting priorities. * Advanced and demonstrated proficiency with Excel. * Self-motivated with the ability to multi-task, work independently and with minimal direction. * High energy, high ownership of work products and dedication and commitment to driving results. * Work on-site in Rockford, IL. * "Roll-up-your-sleeves" attitude. Competencies Required: * Confident, fact-based decision maker. * Pro-active, looking for new solutions, opportunities and insights. * Approaches problems from different perspectives to suggest and implement solutions. * Forecast issues pro-actively to prevent potential impacts; both internally and externally. * Facilitates communication between team members to ensure efforts are aligned. * Takes accountability for delivering on commitments; owns mistakes and uses them as opportunities for learning and development. * Ability to solve complex problems. * Adept at using logic and reasoning to work through problems and analyze information. * Pro-active approach and leadership style. * Holds self and others accountable for specific deliverables and continuously raises the bar in terms of quality of work-product delivered. Minimum Qualifications: * CPA (CA, CMA or CGA) designation with 10+ years related work experience. * Manufacturing experience required. * Pharmaceutical Industry experience preferred. The base salary hiring range for this position is ($122,000-$150,000) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-LM1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $122k-150k yearly 12d ago
  • Accounting Manager

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Summary The accounting manager will direct a staff and manage all accounting activities to ensure compliance with generally accepted accounting principles, corporate policies, and external audits. In this position you will be responsible for all accounting functions to include but not limited to payroll, accounts payable, accounts receivable, and the monthly closing and preparation of reports in support of all financial statements. You will report to and work closely with the Executive Finance Director ("EFD"), the corporate accounting function and other stakeholders in the organization. Key Responsibilities: * You will be responsible for all aspects of accounting (payroll, accounts payable, accounts receivable, billing, general ledger, fixed assets, audit, etc). * Direct and supervise a team of people and pro-actively manage and coach the team and providing employee development opportunities. * Manage and deliver timely monthly financial close process, including preparing journal entries, ensuring all costs incurred are properly recorded, perform account balance reconciliations and report preparation. * Perform Variance Analysis and review expenses by financial statement line item for reasonability, investigate unusual amounts, make any corrections as necessary, and determine root cause and solutions. * Interact at all levels and with budget owners or other stakeholders to produce timely, efficient and accurate month-end close and all internal management and financial reporting incl. lease accounting. * Participate in the ongoing development & establishment of accounting policies and procedures and operational strategies including the review and implementation of process and system changes. * Drive continuous process improvements leveraging digital technology and support the development and enhancement of the ERP platform (JDE) to ensure systems integrity, financial effectiveness and controls. * Collaborate with external auditors to ensure successful audit results and compliance * Define and maintain department KPI's * Ensure compliance with internal control policies. * Assist with compilation of information for preparation of tax returns * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. * Performs other duties and corporate finance projects as assigned by Manager. Knowledge, Skills and Abilities: * Relevant accounting experience in Manufacturing and/or Supply Chain. * Experience with accounting software JDE or similar ERP platform is a plus * Ability to quickly comprehend a complex organizational structure, including the general ledger structure and various financial systems, is essential * Proven ability to leverage current technology to drive process efficiency and improve accuracy * Advanced analytical skills in combination with excellent written and oral communication skills. * Exceptionally well organized, flexible and easily adaptable to changing conditions. * Ability to work under pressure, meet deadlines and manage conflicting priorities. * Advanced and demonstrated proficiency with Excel. * Self-motivated with the ability to multi-task, work independently and with minimal direction. * High energy, high ownership of work product and dedication and commitment to driving results. * "Roll-up-your-sleeves" attitude. Competencies Required: * Makes confident, fact-based decisions. * Pro-active, looking for new solutions, opportunities and insights. * Approaches problems from different perspectives to suggest and implement solutions. * Forecasts issues pro-actively to prevent potential impacts; both internally and externally. * Facilitates communication between team members to ensure efforts are aligned. * Takes accountability for delivering on commitments; owns mistakes and uses them as opportunities for learning and development. * Ability to solve complex problems. * Adept at using logic and reasoning to work through problems and analyze information. * Pro-active approach and leadership style. * Holds self and others accountable for specific deliverables and continuously raises the bar in terms of quality of work-products delivered. Minimum Qualifications: * CPA (CA, CMA or CGA) designation with 7+ years related work experience in a manufacturing environment, preferably in the Pharmaceutical Industry. The base salary hiring range for this position is ($97,280 - $109,440) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-AK2 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $97.3k-109.4k yearly 60d+ ago
  • Quality Control Coordinator

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Title: Quality Control Coordinator Location: Assembly Drive, Rockford, IL 61109 Shift: 1st Shift SUMMARY The Quality Coordinator assists with coordinating quality activities to ensure that goals and objectives of the team are accomplished within prescribed time frames. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management. Essential Duties and Responsibilities: * Prepares and distributes required documentation for requested production work orders. * Perform documentation review of completed orders to ensure compliance with cGMP's and customer requirements. * Reviews and interprets customer standards, procedures, and specifications for dissemination relative to batch records, forms and material specifications. * Prepares customer required samples for shipment according to approved shipping instructions. * Prepares and submits batch records, accountability reports and necessary documentation to customers to facilitate product release. * Organize internal and customer approval of batch records and specs. * Perform record reviews of both completed and in-process orders to ensure compliance with cGMP's and customer requirements. * Perform Line Clearance inspections of equipment and production suites. * Help identify, communicate, track and resolve document related issues with other departments and customers. * Function as one of the customer points for comments or questions pertaining to batch records. * Initiating supplier non-conformance reports and effectuates material control. * Reviews and integrates planned deviation requests into batch records when needed. * Adherence to PCI and cGMP policies, procedures, rules and regulations. * Attendance to work is an essential function of this job. * May perform label creation duties including generating computerized labels. * May perform duties of Quality Auditor as assigned by Supervisor/Manager. * Other duties as assigned by Supervisor/Manager. * Shift is Monday through Friday 8:00 am to 5:00 pm. Qualifications: Required: * High School Diploma or GED * 1-3 years related experience and/or training. * Basic Mathematical Skills * Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables. * High Standard of Report Writing Preferred: * Ability to follow instructions and respond to management direction. * Ability to work independently and/or part of a team. * Ability to display excellent time management skills. * Ability to demonstrate attention to detail. * A college degree with a concentration in a scientific discipline is preferred. * The candidate must be able to demonstrate basic proficiency with computers, business software (e.g. MS Office) and technical software (e.g. Master Control). Ability to create, use and interpret scientific tables, charts, and graphs. Any Lean Six Sigma or process improvement training is a plus. For Illinois residents: the hiring rate for this position is $18.15 to $20.42 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). Equal Opportunity Employer/Vet/Disabled Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $18.2-20.4 hourly 45d ago
  • IC&V Technician 1 (NMSR)

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Location: New Milford School Rd. Shift: 1st (10 hours) Summary of Objective: Sets up, installs, and maintains electrical control systems including, but not limited to, Servo systems (for example, Allen Bradley, Emerson, Elau), OITs (for example, Allen Bradley, Panelview, Panelview Plus, RSView), PLCs (Allen Bradley SLC, Compact, Control Logix), loop controllers, sensors, ID readers, vision systems, VF and DC drives, labelers, lasers, thermal and inkjet printers, and robotics by checking power and wiring; performing power up procedures; firing laser and ensuring code is printing properly; installing and incorporating modules into machines; and servicing equipment and correct any identified issues. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. * AC/DC Control Circuits: Knowledge of electrical devices in AC/DC control circuits (e.g., switches, relays, indicators, motor starters, overloads, contactors, fuses). This includes knowledge of types of devices, limits, and functions. * AutoCAD: The ability to draft equipment drawings and diagrams for design purposes using AutoCAD. * Calibration Procedures and Certifications: Knowledge of the equipment used to rest machine calibrations and the parameters necessary to receive calibration certifications. * Drawings and Diagrams: The ability to read, interpret, and use the information presented in drawings, diagrams, schematics, and blueprints to determine appropriate activities, tools, and next steps in the production process. * Electrical Component Diagnostics: Knowledge of and the ability to troubleshoot and diagnose electrical defects at the component level (e.g., transformers, relays, controllers). * Electrical Knowledge: Knowledge of the basic principles of electricity, wiring, conduit and controls, motors and breakers, and high-low voltage systems. * Electrical Systems: Knowledge of 3-phase electrical systems, including components, repair processes, and installation procedures. * Hand-eye Coordination: The ability to coordinate one's eyes with one's fingers, wrists, or arms to move, carry, or manipulate objects or to perform other job-related tasks. * Hand Tools: Knowledge of and the ability to use a variety of basic hand tools (e.g. wrenches, hammers, screw drivers, knives, scissors, and box cutters). * Pneumatic Components and Diagrams: Knowledge of pneumatic systems and diagrams. This includes knowledge of functions, components, and safety procedures. * Inspection Techniques and Tools: Knowledge of and the ability to apply inspection techniques (e.g. formalized inspection standards, inspection instructions, batch record instructions, best practices), and to use inspection tools efficiently. * Lockout/Tagout (LOTO) Procedures: Knowledge of the processes and procedures to lock out equipment while cleaning, repairing, or servicing. * Machine/Equipment Knowledge: Knowledge of mechanical components, connections, and interdependencies. This includes knowledge of basic machine operations, gears, and drive shafts, and basic electrical wiring. * Machine Maintenance: The ability to perform routine and predictive maintenance on equipment and machines, and determine what maintenance is needed. * Manual Dexterity: The ability to quickly move your hands, your hands together with your arm, or your two hands to grasp, manipulate, or assemble objects. * Material Handling Equipment: Knowledge of and the ability to use material handling equipment, including forklifts, aerial lifts, and pallet jacks. * Measuring Devices: The ability to read and use micrometers, measuring tools, gauges, indicators and calibration stickers. * Mechanical Aptitude: General knowledge of machines and equipment functionality, including how and which tools could be used on such equipment machines. This includes the ability to learn new systems quickly and understand how parts relate and how they impact system functionality. * Packaging Techniques: Knowledge of packing materials, systems, and machinery. This includes the ability to use packaging and labeling equipment to package products in accordance with company guidelines. * PLC Programming: Knowledge of and the ability to read and write programmable logic code for PLCs. This includes knowledge of Allen Bradley and Automation Direct programming, and other control systems. * Power Tools: The ability to properly and safely operate, maintain, repair, clean, and store power tools and equipment (e.g., chop-saw, hand drills, table saws, sanders). * Preventative Maintenance: The ability to identify equipment maintenance needs by using PM Work Orders. This includes the ability to communicate these needs to the appropriate persons. * Production Processes: Basic knowledge and development of plant production processes and layouts, which includes cross-departmental coordination, communication, and planning within our area of responsibility. * Servo Drives: The ability to commission, program, and diagnose motion systems. * Vision-Systems: Knowledge of machine vision systems, including the ability of program code-reading systems. * Visual Acuity: The ability to see details (e.g., letters, numbers, codes, color, symbols, marks, labels, signs) clearly, to accomplish work tasks in a safe and efficient manner. * This position may require overtime and/or weekend work. * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules. * Attendance to work is an essential function of this position * Performs other duties as assigned by Manager/Supervisor. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Required: * Skills testing requirements met at the approved grade level for the position. * Associate's Degree in a related field and/or 1-3 years related experience and/or training. * Basic Mathematical Skills * Intermediate Computer Skills: Ability to perform more complex computer tasks and knowledge of various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables. * High standard of report writing. Preferred: * Ability to effectively present information to various people as the job requires. * Ability to follow instructions and respond to management direction. * Ability to identify and resolve problems in a timely manner. * Ability to work independently and/or as part of a team. * Ability to display excellent time management skills. * Ability to display a willingness to make decisions. * Ability to display original thinking and creativity. * Ability to hold oneself in a professional manner. * Ability to adapt to changing work environments. * Ability to set and achieve challenging goals. * Ability to exhibit sound and accurate judgment. * Ability to demonstrate attention to detail. Other titles known: Mechatronics & Robotics Technician, Controls Engineer, Controls Technician, Electronic Technician, Industrial Electrician, PLC Programmer, Electrical Controls Technician The hiring rate for this position is $24.58-$27.65 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-SW1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $24.6-27.7 hourly 48d ago
  • Cleaning Specialist

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Job Description Job Title: Cleaning Specialist Location: Assembly Shift: 1st Shift Summary of Objective: Dedicated and detail-oriented Cleaning Specialist to join our team. In this role, you will be responsible for ensuring the cleanliness and sterilization of our production equipment tooling; ensuring functionality of our machinery and adherence to the production schedule, which is crucial for maintaining optimal production efficiency. Your work will play a vital role in supporting our commitment to quality and safety standards. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities are the following but other duties may be assigned. * Perform thorough cleaning and sanitization of all production equipment tooling, including the disassembly and reassembly of product contact and non-product contact parts as specified by cleaning protocols. * Follow established cleaning procedures for all production equipment tooling to prevent cross-contamination and ensure compliance with hygiene standards. Follow established policies, procedures, and safety regulations without deviation. * Follow strict safety guidelines, wearing appropriate Personal Protective Equipment (PPE). * Safely and effectively use appropriate cleaning agents and chemicals, following specific mixing and usage guidelines. * Mix and prepare cleaning solutions according to safety guidelines. * Use and dispose of cleaning chemicals and other hazardous materials safely and responsibly, in accordance with safety data sheets (SDS). * Visually inspect cleaned tooling/equipment to ensure the production equipment tooling is free of product debris or residue from previous production run prior to releasing. Inspect tooling/equipment to identify potential quality issues, damage, or areas needing attention or immediate repair. * Wrap and secure tooling/equipment to maintain 60-day sanitization period while being transported and stored. * Maintain accurate records of cleaning activities to support operational transparency. * Maintain clean room sanitization through daily, weekly, monthly, and annual cleaning process routines. * Monitor and replenishes clean room inventory and coordinates inventory order requests with the lead/supervisor. * Ensure compliance with cGMP, corporate standards/PCI Quality System (PQS), site policies/procedures, regulatory requirements, and industry standards. Communicate regularly and effectively. Work cross functionally to ensure communication within the business is always up-to-date and utilizes all available channels. * Effective communication skills to coordinate with team members and report issues to supervisors. * Maintains attention to detail and quality while completing multiple or repetitive tasks and meeting product timelines. * Partner with the PCI Validations department to prepare, execute, and close out validation documentation for tooling and process validation. * Partner with Quality Systems to issue and reconcile PCI functional department logbooks. (Production, Maintenance, Quality). * Perform documentation and records review of completed logbooks to ensure compliance with cGMP's and customer requirements. * Ensure all documentation aligns with quality standards, regulatory requirements, and company policies. * Strong understanding of quality assurance principles and regulatory practices is essential for this role. * Use and effectively navigate PCI EDMS to obtain controlled documents and training relating to job role. * Reads, understands and communicates information contained in controlled documents. * Complete and attend required annual bloodborne pathogen training to stay informed about dangers and safe procedures. * Responsible for the safe and thorough cleaning, disinfection, and removal of blood and other potentially infectious materials (OPIM) from a variety of settings. * Participate in all required PAPR training sessions, medical evaluations, and fit testing to ensure competence and proper function of the equipment. * Follow all required safety protocols, including wearing a PAPR in designated areas or during specific tasks that pose a respiratory hazard. * The skill to prioritize tasks and work efficiently to meet deadlines. * The capacity to work effectively with minimal supervision. * Attendance at work is an essential function of this position. * This position may require overtime and/or weekend work. * Performs other duties as assigned by Manager/Supervisor. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: * Skills testing requirements met at approved grade level for position. * Basic Mathematical Skills * Familiarity with cleaning agents and safety protocols. * 1-2 years of experience in Quality and/or providing support in a manufacturing environment. * Strong attention to detail and ability to follow instructions accurately. * Ability to adapt to changing priorities and work efficiently in a fast-paced setting. * Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. * Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations. Preferred: * Ability to work independently and/or as part of a team. * Proven experience in a manufacturing or industrial clean room. * Proven experience in a quality role, preferably in a manufacturing or industrial environment. * Ability to follow instructions and respond to management direction. * Ability to display a willingness to make decisions. * Ability to display excellent time management skills. * Strong work ethic and commitment to maintaining a clean and safe work environment The hiring rate for this position is $19.96 - $22.45/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-DT1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $20-22.5 hourly 3d ago
  • Maintenance Mechanic 2 - 1st Shift (Mon-Thurs; 5:45am-4:00pm)

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Position Title: Maintenance Mechanic 2 Location: 18th Ave, Rockford, IL 61109 The Maintenance Mechanic's duties include installing, troubleshooting, maintaining, and repairing equipment while following all work practices and procedures. Mechanics will ensure and help maintain a safe work environment while supporting the internal customer to achieve the site's business goals and objectives. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Support the packaging lines by making routine and non-routine adjustments that ensure a high-quality product. * Collaborate with other departments and other Maintenance Mechanics to obtain information or experience to keep lines running at an efficient rate. * Perform preventive maintenance, changeovers, repairs, and running adjustments. * Systematically gather information from a variety of sources, analyze the information, identify implications of data, draw appropriate conclusions, generate viable, alternative solutions to a question or problem, and evaluate the consequences of choosing each alternative. * Assert personal ideas and opinions to convince others. This includes gaining others' support through one's own actions, examples, or persuasion in an ethical manner. * Define, diagnose, and resolve problems. This includes seeking, logically examining, and interpreting information from different sources to determine a problem's cause and developing a course of action to resolve the problem and to prevent its recurrence. * Provide guidance to others by responding to questions; observing work activity; giving direction when necessary; and providing on-the-job training. * Use a variety of hand tools and power tools to perform specific duties. * Detect faulty operations, defective material, and report those and any unusual situation to proper personal. * Read and interpret equipment manuals and work orders to perform required maintenance and services. * May require overtime and/or weekend work. * May require use of Personal Protective Equipment (PPE) and Powered Air Purifying Respirator (PAPR). * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. * Prompt escalation to supervisor of any safety issue, quality issue, or downtime following the established escalation protocol. * Perform Single Minute Exchange of Dies, (SMED) activities on packaging lines * Execute initiatives relating to OPEX objectives. * Analyze equipment failures to improve overall reliability of the equipment, while maintaining productivity. * Update setup documentation to ensure all settings are current and accurate. * Work with The Business Units and Scheduling to accurately maintain a timeline for any launches or validations of products. * Audit and maintain a high level of 5's in the facility to help maintain a safe, organized, clean high-performing workplace. * Document and drive actions for specific respected value stream. * Audit the centerline document system to insure sustainability and a high level of productivity. * Attend Tier I Daily Directional Setting (DDS) meeting. Give feedback and follow-ups when outages occur from the centerline document. QUALIFICATIONS: Required: * Skill testing requirements met at approved grade level for position * Must have at least 2-3 years applicable maintenance experience, preferably in a manufacturing environment or 2-year Technical School. * Basic Mathematical and computer skills. Ability to perform basic computer tasks and can operate common computer programs. * Minimum professional proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. * High reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. * Ability to interpret a variety of instructions that may be provided in various forms. Preferred: * Ability to identify and resolve problems in a timely manner; work independently and/or as part of a team; hold oneself in a professional manner; demonstrate attention to detail; and drive for results. * Packaging experience. The hiring range for this position is $24.58 to $29.19/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $24.6-29.2 hourly 3d ago
  • Sales Intern

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Create a more accurate sales data system so that reporting data is accurate. Having accurate data aids in decision making and allows others within the organization to reach out to correct individuals on the BD team. Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $30k-37k yearly est. 22d ago
  • Microbiology Laboratory Internship

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. JOB DESCRIPTION: Position Title: Microbiology Laboratory Intern Location: Assembly Drive. Rockford, IL 61109 Department: Lab Shift: 1st Reporting To: Director, Laboratory Responsible For (Staff): None Brief Project Description: The Laboratory will have an intern to learn vital skills and assist in the Microbiology Department in day-to-day testing. This testing will include biological indicator testing, preparation of basic microbiology medium(s), collection of environmental monitoring samples from various packaging environments and water testing (total plate count and coliforms). The Microbiology Laboratory intern will work in conjunction with the Senior Microbiologist and Microbiologist to assist in the daily operations of the Microbiology Laboratory. This is a first shift, M-F position. ESSENTIAL DUTIES AND RESPONSIBILITIES: Learn day-to-day operations of the Microbiology Laboratory and assist Microbiologists in daily testing activities (biological indicator, total plate count, coliform testing, etc). Preparation of basic microbiological medium to be used in testing in addition to preparing poured plates for the Microbiologists to be used in testing. Perform environmental monitoring testing in various packaging environments with various testing equipment. Understanding technical writing requirements for working in a Laboratory/GMP environment. Assist in the day-to-day Laboratory activities such as washing dishes, operating the dishwasher, putting away supplies/reagents, operation of the autoclave, etc. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor. Special Demands: * Stationary Position: None * Move, Traverse: 3/4 of the day and up. * Operate, activate, use, prepare, inspect, or place: 3/4 of the day and up. * Install, place, adjust, apply, measure, use, or signal: 3/4 of the day and up. * Ascend/Descend or Work Atop: 3/4 of the day and up. * Position self (to) or Move (about or to): 3/4 of the day and up. * Communicate or exchange information: 3/4 of the day and up. * Detect, distinguish, or determine: 3/4 of the day and up. On an average day, the individual can expect to move and/or transport up to 25 pounds between 1/2 and 3/4 of the day. QUALIFICATIONS: Required: * Working toward Bachelor's Degree in related field. * College Level Math Skills * Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. Preferred: * Ability to effectively present information to various people as the job requires. * Ability to work independently and/or part of a team. * Ability to display original thinking and creativity. * Ability to hold oneself in a professional manner. The hiring rate for this position is $20.00hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $20 hourly 23d ago
  • Clinical Regulatory Affairs Specialist 2

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives involving matters of government and regulations, with respect to the FDA, DEA, MHRA, EEU, State of Illinois, and other regulatory agencies. This position hosts audits for current and prospective clients. This position does not have any supervisory responsibilities. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Write and implement procedures according to the current Code of Federal Regulations. * Assure that company policies are properly followed and applied by all appropriate personnel. * Assists the Regulatory Affairs Manager by hosting audits, developing appropriate corrective actions documented through the audit reports and ensuring proper implementation. * Oversee regular inventories of Controlled Substances for ARCOS reporting and required inventory reports. * Acts as a subject matter expert to other internal resources for concepts within 21CFR 210 & 211 as well as the Control Substances Act. * Create, review and maintain appropriate Clinical Customer Quality Agreements both globally and site specific. * Review and maintain appropriate Site Master Files. * Manage and monitor Audit Corrective Actions. * Write audit responses pertaining to customer and/or internal observations, and track completion of actions. * Review investigations associated with DEA Controlled Products. * Submit applicable registration applications. * Prepare and present monthly Clinical metrics including Customer specific and overall departmental values. * This position may require overtime and/or weekend work. * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. * Attendance to work is an essential function of this position * Performs other duties as assigned by Manager/Supervisor. QUALIFICATIONS: Required: * Bachelor's Degree in a related field and/or 5-10 years related experience and/or training. * Basic Mathematical Skills * Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. * High Standard of Report Writing Preferred: * Ability to work independently and/or as part of a team. * Ability to demonstrate attention to detail. * Ability to identify and resolve problems in a timely manner. * Ability to hold oneself in a professional manner. The base salary hiring range for this position is ($69,920 - $78,660) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-RS1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $69.9k-78.7k yearly 60d+ ago
  • Maintenance Clerk - 2nd Shift

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective: Administer the daily activities related to part issuance for the maintenance department. Assist Technical Maintenance Planner and Inventory Control Analyst in the administration of departmental projects. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. * Deliver MRO parts to PRTs on the lines in a timely fashion. Create Work Orders to document repair, time and parts issued. * Assist in determining needed parts that are not stocked, coordinate expedited delivery if necessary. Determine appropriate stocking levels. * Work with vendors on parts that need recoating/re-rubbering/repairing. Also work with vendors who accept old parts as trade in. Coordinate with radio vendor on repairs/warrantied work. Ensure scrap material is picked up in a timely manner. * Make vinyl, and engraved signs per internal customers instructions. Maintain stock levels of all needed sign supplies. Make Asset Tags as requested. * Assist in receiving stock items with entry to system, replenishment of shelves. * Perform routine spare parts cycle counting on a weekly basis. * Perform Maintenance and repair on gearboxes, glue nozzles and other repairable equipment. Coordinate with Machine Shop on sharpening of all blades. * This position may require overtime and/or weekend work. * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. * Attendance to work is an essential function of this position * Performs other duties as assigned by Manager/Supervisor. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: * Skills testing requirements met at approved grade level for position. * Basic Mathematical Skills * Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs. * Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. * Basic Reasoning: Ability to apply common sense understanding to carry out uninvolved written or oral instructions. Ability to deal with problems that involve only a few concrete variables in standardize situations. Preferred: * Ability to adapt to changing work environments. * Ability to work independently and/or part of a team. * Ability to display excellent time management skills. * High School Diploma or GED. The hiring rate for this position is $18.15 -$20.42/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $18.2-20.4 hourly 2d ago
  • Business Unit Inter

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Job Title: Business Unit Intern Department/Group: Project Management Location: Assembly The hiring rate for this position is $20.00hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). Execute documentation preparation for 24/7 production environment. Manage lot & expiration form creation, administrative planning tasks, and outbound finished goods shipments. Identify potential process improvements to improve efficiency. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Support cGMP documentation creation and transactions as it pertains to lot/expiration form creation, outbound finished good shipments, and inventory reporting Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor. Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions * Stationary Position: From 1/2 to 3/4 of the day. * Move, Traverse: From 1/4 to 1/2 of the day. * Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day. * Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day. * Ascend/Descend or Work Atop: None. * Position self (to) or Move (about or to): From 1/4 to 1/2 of the day. * Communicate or exchange information: 3/4 of the day and up. * Detect, distinguish, or determine: Up to 1/4 of the day. On an average day, the individual can expect to move and/or transport up to 10 pounds less than 1/4 of the day. This position may have the following special vision requirements. * Close Vision ☐ Distance Vision ☐ Color Vision ☐ Peripheral Vision ☐ Depth Perception * Ability to focus ☒ No Special Vision Requirements Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time. * Work is primarily performed at a desk and/or in an office environment for 3/4 of the day and up. The noise level in the work environment is typically, moderate. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: * Working toward Bachelor's Degree in related field. * College Level Math Skills * Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. Preferred: * Ability to effectively present information to various people as the job requires. * Ability to work independently and/or part of a team. * Ability to display original thinking and creativity. * Ability to hold oneself in a professional manner. Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $20 hourly 23d ago
  • Validation Analyst 1

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Validation Analyst I is responsible for overall validation project management of small customer account(s) under heavy supervision. Responsible for generation and execution of validation protocols, assistance in customer audits, and determination of customer validation needs. This job has no supervisory responsibilities. * Performs validation activities to assure compliance to government and customer requirements. * Prepares validation protocols, validation statements, reports, summaries, and master validation plans for new customer / product / system project launch and maintains existing validated processes / programs at multiple sites as well as organizing and coordinating internal and customer approvals, as needed. * Ensures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required. * Prepares change control and validation history report for audits. * Attends conference calls and meetings. Effectively communicates project goals and progress to Validation Supervisor / Manager. * Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete project. * Primary contact for quality validation activities and managing expectations. * Reviews and interprets standards, procedures and specifications for dissemination relative to validation protocols. * Knowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements. * Required to complete and pass a "Documentation Boot Camp" course within 6 months. * This position may require overtime and/or weekend work. * Attendance to work is an essential function of this position. * Performs other duties as assigned. * "Limited Risk Projects" are generally defined as projects/customer accounts that have the following. * Business needs of customer/project require standard time commitments. * Low level of uncertainty in managing customer expectations. * Standard validation approach as documented in the Validation Plan. * Established criteria that are subject to minimal interpretation. * After basic training, this position will be required to specialize in 1 or more Validation areas of focus: * Process/Cleaning Validations * HVAC/Utility Validations * Computer Validations * Required: * High School Diploma or GED and/or 1-3 years related experience and/or training. * Basic Mathematical Skills * Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs. * Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. * Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations. * Preferred: * Process/Cleaning Validation Focus: Background in Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Devices. Must be able to properly gown and work in an active packaging operation. * HVAC/Utility Validation Focus: Familiarity with HVAC wiring diagrams, control design, calibration, instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems. * Computer Validation Focus: Ability to perform complex computer tasks and have some experience with computer systems considered to have an impact on cGMP, cGXP, Annex 11 and PCI guidelines For Illinois residents: the hiring rate for this position is $19.96 to $22.46 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). Equal Opportunity Employer/Vet/Disabled Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $20-22.5 hourly 16d ago
  • Process Engineer Intern

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Job Title: Process Engineer Intern Department/Group: Operations Location: NMSR The hiring rate for this position is $xx.xx/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). Summary of Objective: The Process Engineer Intern will play a crucial role in evaluating and analyzing production processes to optimize efficiency and productivity. This position will involve collecting and analyzing data related to output rates and capabilities of specific production lines, contributing to process improvement initiatives, and collaborating with cross-functional teams to drive continuous improvement. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. * Collect data using Factory MES to determine the average output rate of designated production lines. * Gather validated data to record the validated capability of a group of focus lines, ensuring accuracy and reliability. * Analyze collected data to identify trends, patterns, and opportunities for process optimization. * Collaborate with senior engineers and cross-functional teams to develop and implement process improvement initiatives. * Assist in conducting experiments, trials, and tests to validate process improvements and enhancements. * Prepare reports, presentations, and documentation to communicate findings and recommendations effectively. * Participate in meetings, workshops, and training sessions to enhance technical skills and knowledge. * Adhere to safety protocols, quality standards, and regulatory requirements in all job functions. * Perform other duties and tasks as assigned by supervisors or project leads. * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. * Attendance to work is an essential function of this position * Performs other duties as assigned by Manager/Supervisor. Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions * Stationary Position: From 1/2 to 3/4 of the day. * Move, Traverse: From 1/4 to 1/2 of the day. * Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day. * Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day. * Ascend/Descend or Work Atop: None. * Position self (to) or Move (about or to): From 1/4 to 1/2 of the day. * Communicate or exchange information: 3/4 of the day and up. * Detect, distinguish, or determine: Up to 1/4 of the day. On an average day, the individual can expect to move and/or transport up to 10 pounds less than 1/4 of the day. This position may have the following special vision requirements. * Close Vision ☐ Distance Vision ☐ Color Vision ☐ Peripheral Vision ☐ Depth Perception * Ability to focus ☒ No Special Vision Requirements Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time. * Work is primarily performed at a desk and/or in an office environment for 3/4 of the day and up. The noise level in the work environment is typically, moderate. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: * Working toward a Bachelor's Degree in a related field. * College Level Math Skills * Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. Preferred: * Ability to effectively present information to various people as the job requires. * Ability to work independently and/or part of a team. * Ability to display original thinking and creativity. * Ability to hold oneself in a professional manner. Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $33k-41k yearly est. 23d ago
  • Maintenance Operations Intern

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Summer Intern will develop and lead a Preventative Maintenance Optimization project. Individuals will also set up a robust JDE parts tracking process to reduce stock outages and reduce order prep time. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Works with Manager to review project plans to achieve assignment goals, including understanding project activities, deadlines and key stakeholders. Develop documents, files and materials as needed for the project. Write instructions, records activities and verify. Coordinates with coworkers as a team member to support achievement of project goals. Interacts via email, telephone, and meetings. Assists with preparing and facilitating meetings and working sessions to gather information. Research and analyze equipment usage from various reports or log books. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules Attendance to work is an essential functions of this position Perform other duties as assigned by Manager/Supervisors Develop the process of taking pictures of repair parts Create pictures and attach to the MN parts in JDE Navigate JDE to see pictures from the production floor Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions * Stationary Position: From 1/4 to 1/2 of the day. * Move, Traverse: From 1/4 to 1/2 of the day. * Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day. * Install, place, adjust, apply, measure, use, or signal: None. * Ascend/Descend or Work Atop: None. * Position self (to) or Move (about or to): Up to 1/4 of the day. * Communicate or exchange information: From 1/2 to 3/4 of the day. * Detect, distinguish, or determine: 3/4 of the day and up. On an average day, the individual can expect to move and/or transport up to 10 pounds less than 1/4 of the day. This position may have the following special vision requirements. * Close Vision ☐ Distance Vision ☐ Color Vision ☐ Peripheral Vision ☐ Depth Perception * Ability to focus ☒ No Special Vision Requirements Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time. * Work is primarily performed at a desk and/or in an office environment. for 1/4 to 1/2 of the day. * Work near moving mechanical parts for up to 1/4 of the day. The noise level in the work environment is typically, moderate. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: * High School Diploma and/or 3 months - 1 year relatead experience and/or training. * Basic Mathematical Skills * Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs. * Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers. * High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. * Currently enrolled in a college 4-year program. Preferred: * Ability to work independently and/or as part of a team. * Ability to hold oneself in a professional manner. * Ability to adapt to changing work environments. * Ability to follow instructions and respond to management direction. * Ability to effectively communicate and present information to various teams at various levels. The hiring rate for this position is $20.00/hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $20 hourly 12d ago
  • Manager, Quality Clinical Svc

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective: Plans, directs, and coordinates Quality activities of a designated Clinical Customer Focused Team to ensure that goals and objectives of the team are accomplished within prescribed time frames and in budget. Select, supervise, empower, coach, develop and retain a team of qualified individuals including: Quality Specialist(s) and Quality Coordinator(s) while partnering with the Sr. Clinical Project Manager to ensure that we deliver a quality product, on time. Drives project success through active leadership to provide PCI a competitive advantage in long-term quality customer management. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities are included in the following but other duties may be assigned. * Select, supervise, empower, coach, develop and retain a team of qualified individuals through effective employee development, performance management, succession planning and recognition. * Ensure the appropriate team structure is in place by performing workload analysis to manage headcount and to ensure we deliver on customer and business commitments. * Establish quality team and individual goals and objectives in alignment with Clinical Customer Focused Team goals and customer requirements. * Ensure strong alignment and coordination with other business units and functional groups. Collaborate on best practices with other Clinical Quality Managers and leadership. * Facilitate the daily quality of team performance to ensure goals and objectives are met and to build a culture of safety, quality, performance, customer service and continuous improvement. * Manage the training and development of the team including cross training initiatives and on-boarding of new employees to the team. * Provide support for customer audits, visits and conference calls. Work with Clinical Customer Focused Team to develop systemic corrective actions to any deviations noted. * Oversee investigations, consumer complaints, CAPAs, DEA activities, NMR issues, etc. * Collaborate with the other team members to manage the team performance metrics and customer scorecard. * Collaborate with the appropriate Account Executive and Sr. Project Manager to coordinate and facilitate the customer Quarterly Business Review's. * Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by Design. * Adherence to PCI and cGMP policies, procedures, rules and regulations. * This position may require overtime and/or weekend work. * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. * Attendance to work is an essential function of this position. * Performs other duties as assigned by Manager/Supervisor. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: * Bachelor's Degree in a related field and/or 7-10 years related experience and/or training. * Statistical and Advanced Mathematical Skills * Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms. Preferred: * Project Accomplishment Experience The hiring rate for this position is $77,600-$87,300 plus eligibility for an 10% annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan. #LI-SWI Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $77.6k-87.3k yearly 9d ago
  • Complaint and Investigation Engineer

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective: Summary Overall responsibility of the Complaints and Investigations Engineer is to compile information pertaining to consumer complaints and deviations and analyze the systems, processes and procedures to properly respond to the reported and identified defects or issues. This position helps drive project success and identify improvements to provide PCI a competitive advantage in long-term quality customer management. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. * Primary customer contact responsible for receipt and logging of consumer complaints and product related investigations in EQMS. * Responsible for maintaining complaint and investigation tracking systems. * Verify validity of complaint information provided by customers. * Communicate status of complaints and investigations at performance meetings. * Compile information necessary to log for trending only complaints as well as complaints which require a formal response into the complaints system. * Employ data driven tools and methodologies to perform root cause analysis when investigating complaint responses and deviations. * Interpret technical specifications, product requirements and design concepts for components, assemblies, and products to identify opportunities and develop recommendations to improve product and process design. * Write Deviation Notifications for complaints not caused by PCI. * Enter, monitor, track, extend, and close complaint and investigation actions in EQMS. * Populate, maintain and update priority lists utilized by organization and publish as needed. * Populate, maintain and update various spreadsheets utilized for trending of products, defects, lines, etc. * Compile data and generate complaint and investigation related metrics (prepare graphs and charts from various data sources). * Coordinate and maintain documents associated with complaints and investigations. * Coordinate retain sample request, retrieval, inspection, and return. * Filing and maintaining archived documents and returned complaint samples. * Address and resolve quality events to solve problems and improve systems * Develop and implement corrective and preventative action plans. * Document quality event resolution in a formal report. * Function as a resource for statistical analysis. * Support Quality Control in maintaining GMP compliance and system improvement. * Support Customer audit activities. * Evaluate statistical data as it pertains to investigation and complaint reports. * Monitor and respond to customer questions/concerns. * Complete Retain Only Review form as requested by the customer. * This position may require overtime and/or weekend work. * Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. * Attendance to work is an essential function of this position * Performs other duties as assigned by Manager/Supervisor Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required: * Bachelor's Degree in a related field and/or 1-3 years related experience and/or training. * College Level Mathematical Skills * Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables. * Preferred * Ability to adapt to changing work environments. * High Standard of Report Writing The hiring rate for this position is $62,960-$70,830 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan. #LI-SW1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $63k-70.8k yearly 22d ago
  • IC&V Technician 1

    PCI Services 4.1company rating

    PCI Services job in Rockford, IL

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Weekend B: Friday, Saturday and Sunday ( 7:00pm-7:00 am) Includes an additional 24% shift premium. Summary of Objective: The Instrument Control and Vision Technician's duties include setting-up, installing, troubleshooting, maintaining and repairing equipment while following all work practices and procedures. Technicians will maintain a safe work environment, while supporting the internal/external customers and site goals and objectives. This is an entry level position into I.C.&V, the ideal candidate will be required to understand and perform the basic vision set-ups and basic troubleshooting along with the basic comprehension of electrical troubleshooting. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned. Knowledge of electrical devices in AC/DC control circuits (e.g., switches, relays, indicators, motor starters, overloads, contactors, fuses). This includes knowledge of types of devices, limits, and functions. PLC Programming: Knowledge of and the ability to read and write programmable logic code for PLCs. Vision-Systems: Knowledge of machine vision systems, including the ability of program code-reading systems. Servo Drives: The ability to understand the functionality of servo-drives. The ability to read, interpret and use the information presented in drawings, diagrams, schematics and blueprints to determine appropriate activities, tools and next steps in the production process or systems being used; and keeping licensing up to date. Electrical Systems: Knowledge of 3-phase electrical systems, including components, repair processes, and installation procedures. Preventative Maintenance: The ability to identify equipment maintenance needs by using PM Work Orders. This includes the ability to communicate these needs to the appropriate people. Pneumatic Components and Diagrams: Knowledge of pneumatic systems and diagrams. This includes knowledge of functions, components, and safety procedures. Lockout/Tagout (LOTO) Procedures: Knowledge of the processes and procedures to lock out equipment while cleaning, repairing or servicing. Production Processes: Basic knowledge and development of plant production processes and layouts, which includes cross-departmental coordination, communication, and planning within our area of responsibility. Power Tools: The ability to properly and safely operate, maintain, repair, clean, and store power tools and equipment (e.g., chop-saw, hand drills). Manual Dexterity: The ability to quickly move your hands, your hands together with your arm, or your two hands to grasp, manipulate, or assemble objects. Hand-eye Coordination: The ability to coordinate one's eyes with one's fingers, wrists, or arms to move, carry, or manipulate objects or to perform other job-related tasks. Visual Acuity: The ability to see details (e.g., letters, numbers, codes, color, symbols, marks, labels, signs) clearly, to accomplish work tasks in a safe and efficient manner. This position may require overtime and/or weekend work. Collaborate with the Maintenance Mechanics in problem solving and equipment set-up. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position. Performs other duties as assigned by Manager/Supervisor. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Required: * Skills testing requirements met at approved grade level for position. * Associate's Degree in a related field and/or 1-3 years related experience and/or training. * PLC (Programmable Logic Controller) experience * Machine Electrical troubling experience * Basic Mathematical Skills * Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. * Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. * Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables. * High standard of report writing. Preferred: * Ability to effectively present information to various people as the job requires. * Ability to follow instructions and respond to management direction. * Ability to identify and resolve problems in a timely manner. * Ability to work independently and/or as part of a team. * Ability to display excellent time management skills. * Ability to display a willingness to make decisions. * Ability to display original thinking and creativity. * Ability to hold oneself in a professional manner. * Ability to adapt to changing work environments. * Ability to set and achieve challenging goals. * Ability to exhibit sound and accurate judgment. * Ability to demonstrate attention to detail. * The hiring rate for this position is $24.58-$27.65 per hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.* #LI-SW1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
    $24.6-27.7 hourly 60d+ ago

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