The Ritedose jobs - 27 jobs

The Bulk Operations Technician- Basic Skills is responsible for starting, operating, cleaning, and assisting the BFS Technician in performing maintenance on production equipment. Responsible for timely documentation of work performed. Responsibilities: Obtain and keep a good working knowledge, assist in performing routine, preventative, and unscheduled maintenance on the following production equipment: Blow-Fill-Seal Machines Resin Handling Equipment Preparing the BFS machines for batch filling. Tasks typically include: changing code magazines, ensuring proper filters are in place and properly tested, connecting the appropriate holding tank to the fill suite, steam sterilization, filter drying, starting the BFS and making initial mechanical and filling adjustments. Monitor the BFS machines and support equipment during the batch filling. Perform routine shift checks and document appropriately. Make adjustments to ampoule weight, forming, and fill volume during batch filling as needed to maintain process control. Performing shutdown procedures at the completion of the batch filling. Tasks typically include: disconnecting the holding tank from the fill suite, in-line WFI cleaning, internal surface cleaning, product filter integrity testing, steaming molds, and changing filters if necessary. Perform filter integrity test on air filters and document appropriately. Perform routine preventative maintenance on the BFS equipment Maintain housekeeping of area and equipment. Maintain complete and accurate documentation of activities to support product disposition. Participate in the internal and external training program. Maintain a professional team-oriented working relationship with fellow employees. Follow Ritedose SOPs, safety and health guidelines and c-GMP Guidelines. Perform routine maintenance on BFS machines. Physical Requirements: Ability to frequently lift and carry up to 40 pounds of equipment, parts or supplies. Qualifications 2 year technical degree or equivalent experience in a manufacturing environment Mechanical or electrical experience in a manufacturing environment. Ability to establish priorities and operating equipment quality expectations. Ability to participate and develop a team-oriented working relationship within the operation.

Collegium Pharmaceutical is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. We have a leading portfolio of responsible pain management and neuropsychiatry medications. POSITION OVERVIEW The ADHD Specialist responsibility is to compliantly meet and strive to exceed all quarterly and annual sales objectives by executing territory specific sales strategies and plans aimed at driving utilization within their defined geography. RESPONSIBILITIES Achieve territory sales goals/targets on quarterly and/or annual basis. Applies resources (call activity, speaker programs, payer access tools etc.) against best business opportunities, tracks impact and adjusts accordingly. Utilizes different modes of communication: Face-to face, Virtual, or phone to engage customers (HCPs & staff). Analyzes market to understand local dynamics impacting the business and executes against trends that can impact the business. Develops and executes territory business plans and call plans aligned with meeting territory and national objectives. Keeps current on local and national payer access environment and identifies opportunities for pull-through in their local market. Demonstrates thorough understanding of disease state, treatment approaches, competition, and our product, to serve as a valued resource to our customers. Partners with key stakeholders internal/external to help remove barriers to access. Participates in industry meetings, conventions and exhibits as necessary to build relationships and strong awareness of brand and company. Leverages selling model to build a call continuum over time with logical and sequential steps to gain commitment and action from customers. Takes ownership by actively seeking out challenges and resolving problems to build solutions that consider implications on the customer and the larger organization. Setting high goals for personal and group accomplishment; using measurement methods to monitor progress toward goals; tenaciously working to meet or exceed goals while deriving satisfaction from that achievement and continuous improvement. Leveraging business tools to evaluate data using strategic and critical thinking skills to build business / call plans to drive performance Ensuring that the customer perspective is a driving force behind business decisions and activities; crafting and implementing service practices that meet customers' and own organization's needs. Using appropriate interpersonal styles and communication methods to gain acceptance of a product, service, or idea from prospects and clients. Keeping the organization's vision and values at the forefront of associate decision making and action; ensure all compliance standards and company policies and procedures are adhered to. REQUIRED LEADERSHIP BEHAVIORS Leadership Behaviors are a core set of behaviors that vary based on Level in the organization categorized under Head, Heart, and Guts. Head Know our Business Think Critically Decide Execute Heart Collaborate Develop Communicate Embrace Authenticity Guts Be Disruptive Innovate Evolve Be Tenacious COMPETENCIES Setting high goals for personal and group accomplishment; using measurement methods to monitor progress toward goals; tenaciously working to meet or exceed goals while deriving satisfaction from that achievement and continuous improvement. Acting as a tenacious high-performing sales professional who excels at identifying and seizing new opportunities within their market and demonstrative relentless drive and determination to achieve sales targets and expand market presence. Leveraging business tools to evaluate data using strategic and critical thinking skills to build business / call plans to drive performance Ensuring that the customer perspective is a driving force behind business decisions and activities; crafting and implementing service practices that meet customers' and own organization's needs. Using appropriate interpersonal styles and communication methods to gain acceptance of a product, service, or idea from prospects and clients. Keeping the organization's vision and values at the forefront of associate decision making and action; ensure all compliance standards and company policies and procedures are adhered to. QUALIFICATIONS Bachelor's degree required. 2-4 years of pharmaceutical sales or equivalent life sciences sales experience required and experience in specialty sales strongly preferred: Neuroscience, psychiatry; ADHD/Pediatric psychiatry Strong account based selling skills with demonstrated success in prior sales roles Working knowledge of strategies and tactics to pull-through local formulary wins. Understanding of prior authorization process and experience partnering with key healthcare providers and office personnel on manufacturer sponsored market access support programs preferred. Have a valid driver's license and be insurable. Pay Range$113,300-$129,403 USD Collegium is an equal opportunity employer. It is the policy of Collegium, in all of its relations with its employees and applicants for employment, to base all employment-related decisions upon valid job-related factors, without regard to age, national origin, citizenship status, ancestry, race, color, religion, creed, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or expression (including transgender status), sexual orientation, military or veteran status, physical or mental disability, genetic information, or any other status protected by applicable federal, state, or local law. This policy applies to hiring, training, promotion, compensation, disciplinary measures, access to facilities and programs, and all other personnel actions and conditions of employment. By this policy, Collegium seeks to ensure that all employees have the opportunity to make their maximum contribution to Collegium and to their own career goals. This policy provides for an equal employment opportunity program that will simultaneously serve the requirements of society, the law, sound business practices and individual dignity. If you have questions or concerns about equal employment opportunities in the workplace, you are encouraged to bring these issues to the attention of the Head of Human Resources. We will not allow any form of retaliation against employees who raise issues of equal employment opportunity. To ensure our workplace is free of artificial barriers, violation of this policy may result in disciplinary action, up to and including termination.

Job Purpose: * Provide real-time QA oversight across BFS and aseptic manufacturing to ensure compliant, accurate, and efficient execution of GMP production activities. * Ensure full adherence to FDA, cGMP, and internal Quality System requirements through on-floor presence, documentation oversight, and cross functional coordination. * Lead, develop, and support the Quality Operations team, promoting a strong culture of compliance, ownership, and right-first-time performance. * Drive operational and quality excellence through proactive issue identification, timely decision-making, and effective cross functional partnerships. * Support continuous improvement initiatives to strengthen documentation practices, reduce deviations, and enhance audit readiness. * Oversee and support Visual Inspection operations Essential Duties and Responsibilities: * Provide daily oversight of BFS and aseptic operations, including observation of critical process steps, cleanroom behaviors, and adherence to established parameters. * Ensure batch execution aligns with cGMPs, SOPs, and documentation standards; review in-process documentation for accuracy, completeness, and right the first time expectations. * Maintain a high state of inspection readiness for regulatory, state, and customer audits through routine walkthroughs, documentation checks, and reinforcement of quality behaviors. * Provide QA oversight of Facilities and Engineering work performed in or impacting GMP areas, including documentation verification and approvals in validated electronic systems. * Support deviation investigations, including documentation of events, fact gathering, root cause analysis, and CAPA implementation. * Ensure timely and accurate review of batch records, logbooks, and supporting documentation; identify trends and error patterns for corrective action. * Collaborate with respective departments to resolve realtime issues and support continuous improvement of processes, documentation, and material flow. * Provide coaching, mentoring, and training for QA and Production personnel regarding documentation accuracy, procedural compliance, and GMP expectations. * Develop, monitor, and report key quality metrics such as right the first time, documentation errors, and operational compliance trends. * Promote contamination control, aseptic discipline, and strong adherence to cleanroom requirements across all shop floor operations. * Communicate quality issues and significant observations promptly to Quality leadership to support timely decision-making and escalation when required. * Ensure visual inspectors are properly trained and qualified for operations. * Verify adherence to approved inspection procedures and support development and maintenance of work instructions and defect libraries. * Perform any other duties related to the Quality Assurance function as necessary or assigned. Job Specifications and Qualifications: Knowledge & Skills: * Strong understanding of cGMPs, FDA regulations, Quality Systems, and documentation requirements supporting sterile manufacturing. * Knowledge of sterility assurance concepts, cleanroom behavior, and contamination control within aseptic or BFS environments. * Experience reviewing batch records, assessing documentation accuracy, and supporting deviation and CAPA processes. * Ability to lead, coach, motivate, and develop Quality Operations personnel. * Strong analytical, problem-solving, and root cause analysis skills. * Effective communication, technical writing, and cross-functional collaboration capabilities. * Proficiency with Microsoft Word, Excel, PowerPoint, and electronic Quality Systems. * Strong attention to detail, time management, and organizational skills. Education/Experience: * Bachelor of Science degree preferred. * 5+ years of Quality Assurance experience in sterile pharmaceutical manufacturing preferred. * 3+ years of supervisory or management experience in a GMP environment preferred. * Experience supporting regulatory inspections and interacting with auditors. * Familiarity with BFS or aseptic production environments strongly preferred. Working Conditions / Physical Requirements: * Requires routine walking through production areas, standing, bending, typing, and lifting up to 40 lbs. * Requires gowning and work within cleanroom environments.

Job Purpose: Secondary Packaging's main objective is to place primary packaged products into outer packaging that provides additional protection for distribution and retail. The secondary packaging process ensures the safe, compliant, and efficient transport of the pharmaceutical products. Essential Duties and Responsibilities: * Monitor the operation of Secondary Packaging equipment to determine trends (i.e. vials per minute and pallets packaged per shift. * Responsible for overseeing changeovers and end of lot procedures. * Responsible for reconciliation in the MBR. * Responsible for training new personnel on your shift. * Responsible for starting, stopping and repairing minor problems with Secondary Packaging equipment. * Initiate and manage any document, equipment, or process change related to non-conformance investigations as corrective/preventive action. * Coordinate training sessions on new documents or processes. * Ensure completion and implementation of CAPAs (corrective/preventive actions). * Coordinate and update the daily packaging schedule in the absence of the Operations Manager. * Initiate, create, and manage any document, equipment, or process change as delegated by Operations management. * Writes or reviews manufacturing procedures and related document. * Prepare and review internal documentations for management and production staff. * Participates in internal GMP audits and supports customer and regulatory audit response. * Assists with additional work duties or responsibilities as evident or required. * Performs other duties as assigned or apparent. Supplemental Functions: * Work under the direction of the Director or designee. * Assure the efficient performance of all department equipment. * Assist with housekeeping as needed. * Adhere to GMPs and hold those around them accountable. Job Specifications and Qualifications: Knowledge & Skills: * Knowledge of the Pharmaceutical of Manufacturing Industry preferred. * Must be able to pass a Drug Test. * Must speak, write, and read English. * Specific expertise, skills and knowledge gained through education and experience. * Ability to take strategic objectives and accept accountability to drive results through effective actions. * Ability and willingness to change direction and focus to meet shifting organizational and business demands. * Ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. * Ability to create new products and processes that add value to the business by generating new ideas, applying creative, and analytical approaches. * Ability to prioritize tasks, manage time efficiently, and meet deadlines. * Familiar with relevant industry regulations and compliance standards. * Incumbents required to wear safety glasses, hearing protection and other non-specified protective equipment as necessary. * Strong critical thinking, analytical, problem-solving, and interpersonal skills. * Strong organizational skills with the ability to manage multiple projects or assignments simultaneously. Education/Experience: * High school diploma or equivalency is required. * Prefer 2yrs of manufacturing or pharmaceutical experience but not required. Working Conditions / Physical Requirements: * This position requires lifting (up to 50lbs), bending, climbing, reaching, good vision, standing, sitting, walking, gripping, talking, and hearing.

Job Purpose: Quality Operations Clean Room Technicians Tier I are to monitor filling operations in compliance with company policies and Standard Operating Procedures, as well as FDA and cGMP regulations. Qualified individuals will be responsible to ensure the accuracy and completeness of batch records, and perform personnel monitoring, general operations filling in manual hoods, and other duties as necessary. Technicians will assist with additional work duties or responsibilities as evident or required. Essential Duties and Responsibilities: * Monitors aseptic techniques of personnel within the clean room. * Monitor Outsourcing filling operations within the clean rooms. * Verifies syringe filling rejects of Outsourcing products and performs quality attribute inspections as needed. * Maintains quality assurance documentation. * Review/sign appropriate sections designated for Pharmacist/QA designee signatures within the batch records. * Promotes teamwork both within the QA Team and other departments. * Monitors all filling areas and personnel for adherence to all cGMP, SOP's and safety regulations. * Keep line and work station clean and orderly to ensure no product line contamination. * Perform line clearance including equipment, components and label verification. * Perform room releases for filling rooms for Outsourcing areas. * Communicate quality - related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor/Management. * Review all completed production batch record documentation to ensure completion and compliance. * Reviewing Logbooks for GDP and accuracy. * Performs general operation QA functions for manual filling processes. * Ability to perform personnel monitoring within the clean room. * Trained and authorized to enter samples into LabVantage. Supplemental Functions: * Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations. * Assist with development of solutions for chronic problems within quality assurance * Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management. * Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. * Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. * Assist in other activities (as needed) for Quality Assurance management. Knowledge & Skills: * Detail oriented. * Good computer skills in MS Outlook, MS Word, MS Excel, Internet, Email and basic typing skills. * Good visual acuity and observation skills. * Good written, oral and comprehensive communication skills. * Able to handle diversity of projects. * Specific expertise, skills and knowledge within quality assurance gained through education and experience. * A board perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities. * The ability and willingness to change direction and focus to meet shifting organizational and business demands. * The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. * The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. * Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary. Education/Experience: * High School Diploma or GED * Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of GMP preferred. Working Conditions / Physical Requirements: * Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25lbs), reaching (waist to head), vision (20/20), standing (40%), sitting (20%), walking (40%), typing and hearing.

Apply Description Job Purpose: The purpose of this position is to support quality control testing and research and development activities as needed by conducting laboratory testing for raw materials, in-process materials, finished product, and stability samples in accordance with approved analytical methods. Essential Duties and Responsibilities: Conduct routine and complex laboratory testing for raw materials, in-process materials and samples, finished product samples, and stability samples in accordance with approved analytical methods. Conduct and execute laboratory work and testing using best-practice analytical techniques and follow laboratory GDP and cGMP requirements Accurately analyze and interpret data using appropriate specifications and test methods. Accurately peer review notebooks and verify raw data to support sample release, including data generated in electronic software systems. Accurately enter data using appropriate reporting systems and release forms. Mentor and train Chemists as needed to support laboratory operations. Assist in troubleshooting equipment, analyses, etc. Support and contribute to investigation documentation, as needed. Supplemental Functions: Relies on instructions and pre-established guidelines to perform job functions. Performs other similar duties as required. Works under supervision. Job Specifications and Qualifications: Knowledge & Skills: Strong analytical skills, problem-solving ability, and attention to detail. Sound understanding of cGMP regulations pertaining to laboratory controls and thorough knowledge of USP and compendia standards. Ability to read, understand, review, and update Standard Operating Procedures, Forms, and Specifications and assist in designing new procedures as necessary independently, subject to management guidance. Ability to perform testing and lead root cause analysis for laboratory investigations for OOS and atypical QC test results, subject to management guidance. Ability to effectively communicate within Chemistry Laboratory Staff and Management, as well as other departments. Acknowledge and identify continuous improvement opportunities in all work activities. Initiate and follow through to implement, track, and achieve on-time completion of testing to support sample release to meet business needs and demands. Ability to effectively use a multitude of resources to perform job functions accurately. Education/Experience: BS or MS in Chemistry, Biochemistry, or related field required with 2-5 years of pharmaceutical experience preferred. Experience outside of pharmaceuticals in chemistry quality control or R&D will be considered for the highly qualified candidate. Experience with conducting analysis by FT-IR, UV/Vis spectroscopy, and wet chemistry techniques is required. Highly skilled in advanced techniques such as HPLC, GC, and ICP testing, needing little or no guidance and supervision. Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 40 lbs.), standing, sitting and walking throughout the facility. This position encounters the following environmental factors: hazardous materials including HPLC solvents, chemical reagents, acids, and other non-specified hazardous materials that are project specific. This position requires safety glasses and other non-specified personal protective equipment to be worn as necessary.

Job Purpose: The Sterile Filling Technician is responsible for performing aseptic filling and related sterile operations within a 503B outsourcing pharmaceutical manufacturing facility. This role ensures products are prepared, filled, and packaged in compliance with FDA 503B regulations, cGMP standards, and company SOPs to ensure product quality and patient safety. __________________________________________________________________________________________ Essential Duties and Responsibilities: Sterile Filling & Operations Ø Perform aseptic filling of injectable pharmaceuticals in cleanroom environments (ISO 5, ISO 7). Ø Operate and monitor sterile filling equipment (e.g., filling machines, cappers, and autoclaves). Ø Conduct manual and automated sterile filling processes according to batch records and SOPs. Ø Support environmental monitoring by maintaining strict aseptic technique. Ø Participate in line clearance, equipment set-up, in-process checks, and end-of-run reconciliation. Compliance & Documentation Ø Complete all batch records, logbooks, and electronic documentation in real time and with accuracy. Ø Adhere to FDA 503B regulations, cGMP, and internal quality policies. Ø Report deviations, non-conformances, or potential quality issues to supervision immediately. Ø Support regulatory inspections and internal audits as needed. Cleanroom & Equipment Maintenance Ø Follow gowning procedures and aseptic practices required for sterile areas. Ø Assist in cleaning, sanitizing, and maintaining cleanroom areas and equipment. Ø Perform equipment setup, operation, and minor troubleshooting under supervision. Teamwork & Continuous Improvement Ø Work collaboratively with Production Scheduling, Sterile Room, Quality, Microbiology, Engineering, and other Manufacturing teams to ensure smooth sterile production runs. Ø Participate in ongoing training programs to maintain qualifications for cleanroom operations. Ø Suggest process improvements to enhance efficiency, safety, and compliance. Supplemental Functions: Ø Performs all other duties as assigned or apparent. Job Specifications and Qualifications: Education / Experience: Ø High School Diploma or GED required; Associate or Bachelor's in Life Sciences preferred. Ø Minimum 1-2 years' experience in sterile pharmaceutical manufacturing, 503B outsourcing, or hospital compounding strongly preferred. Ø Familiarity with cGMP, FDA 503B guidance, and aseptic technique required. Skills & Competencies: Ø Strong knowledge of sterile gowning and aseptic technique. Ø Ability to work in controlled cleanroom environments. Ø Excellent attention to detail, documentation accuracy, and adherence to SOPs. Ø Strong teamwork and communication skills. Licensing and Certifications: Ø Registered Pharmacy Technician Certification Ø Ability to maintain Gowning Certification _____________________________________________________________________________ Working Conditions / Physical Requirements: Ø Work performed primarily in classified cleanroom environments with strict gowning requirements. Ø Ability to lift up to 40 lbs and stand for extended periods. Ø Requires routine handling of sterile materials, chemicals, and equipment. Ø Shift work, weekends, and overtime may be required based on production demands.

Apply Description Job Summary The BFS Line Technician I plays' a vital role in ensuring the efficient and compliant operation of Blow-Fill-Seal machinery used in the production of sterile pharmaceutical products. This position is responsible for operating, monitoring, and maintaining BFS downstream equipment, ensuring product quality, and adhering to all Current Good Manufacturing Practices (CGMP), safety regulations, and company protocols. Key Responsibilities Equipment Operation Set up and operate BFS downstream machinery according to established SOPs and Batch Records. Monitor machine performance and production output to ensure efficiency and compliance. Perform routine adjustments and troubleshoot minor issues to maintain continuous operation. Reset equipment alarms and ensure all materials are properly staged for production. Quality Assurance & Documentation Accurately complete Batch Records, logbooks, setup sheets, and other documentation in a timely manner. Identify and escalate product quality or equipment concerns to supervisors. Ensure all work is completed in strict adherence to CGMP standards. Support investigations into deviations and assist in implementing corrective actions. · Review MBRs and log book for accuracy and GMP standard. Safety & Housekeeping Adhere to all safety protocols and wear proper personal protective equipment (PPE) when needed. Maintain cleanroom and production areas to meet internal and regulatory cleanliness standards. Perform and document routine housekeeping and participate in facility inspections. Teamwork & Communication Collaborate with Quality, Maintenance, Packaging, and other cross-functional teams to ensure smooth operations. Participate in training sessions to build technical and procedural knowledge. Provide guidance and training to new or junior operators as needed. Training & Development Complete required training and maintain certifications in alignment with company and regulatory requirements. Stay updated on procedural changes and complete retraining within designated timeframes. Provide mentorship and training to junior machine operators and new team members in equipment operation, safety protocols, and industry best practices. Other Duties Perform additional responsibilities as assigned to support production goals and departmental needs. Qualifications & Requirements Knowledge, Skills, & Abilities Basic mechanical aptitude and understanding of automated manufacturing equipment. Ability to interpret SOPs, technical documents, and Batch Records. Strong attention to detail with a focus on accuracy and quality. Effective verbal and written communication skills. Team-oriented with the ability to work independently when required. Flexibility to work shifts, weekends, or overtime based on production needs. Available for 12-hour shifts (0600-1830 or 1800-0630), including nights, weekends, or holidays as needed. Education & Experience High school diploma or GED required. Technical certifications or training in manufacturing or mechanical systems preferred. Previous experience in pharmaceutical or sterile manufacturing environments is a plus. Familiarity with BFS technology is highly desirable. Work Conditions & Requirements Must be able to lift up to 50 lbs and stand for prolonged periods in a cleanroom environment. Must wear all required PPE, including gloves, gowns, masks, and goggles. Available for 12-hour shifts (0600-1830 or 1800-0630), including nights, weekends, or holidays as needed. Why Join Nephron? Cutting-edge manufacturing environment Commitment to safety, quality, and innovation Growth and development opportunities Team-driven culture with a mission to make affordable medication accessible to all

Apply Description Corporate Statement: Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron's products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmics, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention. As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company's longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and Puerto Rico, with additional sales channels throughout South America, the Middle East, and Europe. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust. ____ Job Purpose: Ø Performs Quality Attribute Inspections of the product through the packaging process in compliance with company policies/procedures, FDA and cGMP regulations. Ø Ensures the accuracy and completeness of batch records. Ø Performs other duties as assigned or apparent. ____ Essential Duties and Responsibilities: Ø Review Batch Records and applicable documentation to ensure complete, thorough and accurate data. Ø Responsible for ensuring a high level of employee accountability and performance. Ø Maintains quality assurance documentation including shift pass downs. Ø Keep QA work station clean and orderly. Ø Perform packaging line clearances. Ø Pull Retain, Stability, and Lab samples. Ø Perform or verify Quality Finished Product Attribute Inspections. Ø Perform AQL Calculations. Ø Verify component Exhibits Ø Verify all documents are present within the batch record. Ø Support validation and manufacturing studies, including special sampling and testing. Ø Communicate with Management any quality issues identified with product Supplemental Functions: Ø Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations. Ø Assist with development of solutions for chronic problems within quality assurance Ø Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management. Ø Adherence to cGMPs is required at all times. All personnel own the quality of the product delivered and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. Ø Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. Ø Assist in other activities (as needed) for Quality Assurance management. ____ Job Specifications and Qualifications: Skills: Detail oriented. Technical writing skills required. Good written, oral and comprehensive communication skills. Operating computer and relevant software;. Must be proficient in MS Word, Excel, and PowerPoint; Abilities: The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication; and provides participation, learning, feedback and recognition. The ability to effectively manage one's self, demonstrates integrity, be productive under pressure, and achieve development goals. Ability to handle contending priorities and managing partner expectations The ability and willingness to change direction and focus to meet shifting organizational and business demands. Assist in other activities (as needed) for Quality Operations management. Must have the ability to make recommendations to effectively resolve problems or issues by using judgment that is consistent with applicable standards, practices, policies, procedures, regulation or government law. Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. Education/Experience: Minimum of High School Diploma or GED required. ____ Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 25 1bs.), standing, sitting and walking throughout the facility. _____ The intent of this job description is to provide a representative summary of the types of duties and responsibilities that will be required of the positions given this title and shall not be construed as a declaration of the specific duties and responsibilities of any particular position. Employees may be requested to perform job-related tasks other than those specifically presented in this description. Nephron Pharmaceuticals is an equal employment opportunity employer and does not discriminate against employees or job applicants on the basis of race, religion, color, sex, sexual orientation, age, national origin, mental or physical disability of a qualified individual, veteran or military status, pregnancy, marital status, familial status, genetic information, or any other consideration made unlawful by applicable federal, state or local law. Nephron Pharmaceuticals is a drug free workplace.

The Microbiologist I is responsible for all duties related to performing environmental monitoring, personnel monitoring, microbial enumeration, microbial identification, and sampling of utilities. The Microbiologist I is also responsible for performing all the microbiological testing related to raw materials, utilities, and in-process product testing. Other responsibilities include data entry, data review, ensuring calibration of equipment, maintaining and ordering inventory of laboratory supplies, and maintaining the Microbiology laboratory by ensuring its cleanliness and order. Please note that the scheduled shift for this position will be 7PM-5:30AM, with rotating weekends. Level 1 - Less than 12 months experience or no experience - Environmental Monitoring Completion - Utilities completion - Microbial Identification (subculture, Gram-stain, ID entry, VITEK MS assist) and enumeration - Raw Material Testing including APIs Responsibilities: Responsible for performing all microbiological testing of raw materials, utilities, and in-process, and final products/stability (as applicable) for commercial and method development. Responsible for performing daily, weekly, semi-weekly, and monthly environmental monitoring of the manufacturing environment and other areas. Responsible for performing enumeration, organism identification including culturing, isolating, entry, and maintaining of organisms. Document and review of raw and final data to ensure complete and proper documentation according to procedures and applicable cGMPs. Notify Microbiology Laboratory management immediately of out of specification (OOS) results. Responsible for routine maintenance and preventative maintenance of laboratory equipment. Notify Microbiology Laboratory management of laboratory equipment problems or calibration issues. Responsible for reviewing and entering microbiological data into finished product batch records and other applicable laboratory documents (i.e. laboratory notebooks). Document and review of raw and final data to ensure complete and proper documentation according per procedures and applicable cGMPs. Responsible for maintaining and entering microbiological data (including Identification) into the Quality database and ensuring all data has been entered by review. Responsible for assisting with investigations for environmental monitoring excursions (action/alert level investigations), deviations, and OOS results as requested by the Microbiology Laboratory management. Responsible for the general maintenance and cleaning of the Microbiology Laboratory (including identification and warehouse areas) including good housekeeping and a safe working environment. Responsible for temperature monitoring, maintenance, and notification of calibration of laboratory equipment. Assist in regulatory audits as requested by Microbiology Laboratory Management. Assist in training of new employees on all applicable SOPs and tasks. Responsible for assisting with ordering and maintaining inventory of laboratory supplies including organization, labeling, and discard of materials. With guidance from Microbiology Laboratory management, assist in review of SOPs. Follow Standard Operating Procedures, safety, health, and cGMP Guidelines. Qualifications B.S. degree in Microbiology or related field. Minimum 0 - 1 year experience. Ability to understand/follow all applicable standard operating procedures and cGMPs routinely. Proficient with current word processing, spreadsheets, and database software. Demonstrated knowledge of standard laboratory techniques and procedures as evidenced by prior work experience or on the job training. Ability to operate standard and advanced laboratory instrumentation as evidenced by prior work experience or on the job training. Ability to participate in and contribute to a team-oriented work environment by developing positive working relationships within quality organization and between other departments.

Job Purpose: The Production Change Control Manager is responsible for overseeing and managing change control activities related to manufacturing operations, including production processes, equipment, facilities, materials, and associated documentation. This role ensures compliance with FDA regulations, cGMPs, and internal quality systems by evaluating the impact of proposed changes, implementing appropriate controls, and maintaining product quality, safety, and regulatory compliance. The Production Change Control Manager serves as a subject matter expert (SME) for change control within manufacturing and provides guidance to cross-functional teams to ensure changes are properly assessed, documented, approved, and implemented Essential Duties and Responsibilities: * Manage and oversee production-related change control activities in accordance with FDA regulations, cGMPs, and company quality policies. * Facilitate the review, coordination, and approval of change records related to manufacturing processes, equipment, facilities, materials, utilities, and production systems. * Evaluate and facilitate review of proposed production changes to assess potential impact on product quality, process performance, validation status, regulatory filings, and compliance. * Ensure all changes are thoroughly documented, including change requests, impact assessments, risk assessments, implementation plans, and effectiveness checks. * Ensure change controls are appropriately linked to validation, qualification, calibration, maintenance, and training requirements, as applicable. * Review controlled documents (SOPs, batch records, work instructions, forms, and labels) to ensure accuracy, completeness, and compliance with approved production changes. * Participate in Change Review Board (CRB) meetings, including presentation of production change metrics, trends, and KPIs. * Present quarterly change control trends and performance metrics at Quality Management Review (QMR) meetings. * Investigate and resolve issues or delays related to change control approvals by collaborating with cross-functional stakeholders. * Monitor the effectiveness of production change implementations and identify opportunities for process improvement. * Ensure data integrity, traceability, and accuracy of all change control records. * Support manufacturing initiatives, campaigns, and special projects requiring change control oversight. * Communicate quality-related risks, issues, or noncompliance related to production changes to Quality Management or designee. * Participate in continuous improvement efforts to enhance the efficiency and effectiveness of production change control processes. * Perform other duties as assigned or required to support manufacturing and quality objectives. Supplemental Functions: * Support and participate in customer, internal, and regulatory audits and inspections, specifically related to production change control. * Educate and train manufacturing and support personnel on production change control procedures, documentation standards, and best practices. * Conduct system access and change control training for new production and support employees. * Periodically review production change control activities and metrics to identify trends, risks, and improvement opportunities. Job Specifications and Qualifications Knowledge & Skills: * Strong technical background with solid knowledge of Quality Assurance, cGMPs, FDA regulations, and QMS-based change control systems. * Hands-on experience managing production change controls within electronic Quality Management Systems (eQMS). * Excellent written and verbal communication skills with strong interpersonal abilities. * Strong analytical, critical-thinking, and problem-solving skills, with high attention to detail and data integrity. * Ability to manage multiple priorities, meet deadlines, and perform effectively in a fast-paced manufacturing environment. * Ability to work independently and collaboratively across cross-functional teams. * Proficient in technical writing and use of Microsoft Word, Excel, and Adobe Acrobat. * Demonstrates professionalism, integrity, and discretion in handling confidential quality and regulatory information. Education/Experience: * Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipline required. * Advanced degree or Quality/Regulatory certification (e.g., ASQ, CQE, CQA) preferred. * 5+years of experience in a regulated manufacturing environment (pharmaceutical, biotech, medical device, or related industry). * 3+ years of hands-on experience managing change control within a QMS or electronic QMS (eQMS). * Demonstrated experience evaluating changes to manufacturing processes, equipment, facilities, utilities, and materials. * Working knowledge of cGMP, FDA regulations, and quality systems governing production operations. * Experience supporting regulatory inspections, customer audits, and internal audits. * Proven ability to collaborate with Manufacturing, Engineering, Validation, Maintenance, and Quality teams. * Experience leading or participating in Change Review Boards (CRB) and presenting change control metrics or KPIs preferred. Working Conditions / Physical Requirements: * This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility. * Willingness to change direction and focus to meet shifting organizational and business demands. * Individual may require to wear specified protective equipment if necessary * Hours of work: Monday thru Friday on 8 hours shift, or as needed based on company demand.

Apply Description The Manager of Financial Planning and Analysis (FP&A) will lead our financial modeling, forecasting, and analysis functions. They will have a deep understanding of financial strategy, exceptional attention to detail, and proven experience in credit modeling, restructuring, or FP&A within a professional services or consulting firm environment. This role requires a blend of strategic thinking, hands-on financial analysis, and teamwork. Essential Duties and Responsibilities: Ø Strategic Financial Leadership: o Develop and implement financial strategies that align with long-term business objectives. o Analyze operational challenges and recommend solutions to optimize financial performance. Ø Operational Efficiency: o Identify inefficiencies in operational processes and recommend cost-saving measures. o Develop actionable insights to improve overall financial health and organizational efficiency. Ø Teamwork: o Foster a collaborative, team-oriented culture that encourages innovation and high performance. Supplemental Functions: Ø Performs other similar duties as required. ____ Job Specifications and Qualifications: Ø Financial Analysis and Modeling: o Build, maintain, and enhance complex financial models, including: § 13-week cash flow forecasting. § Company annual and long-range financial model. § Covenant compliance analysis. § Profitability and liquidity assessment. o Perform sensitivity analyses to evaluate the impact of various financial scenarios. o Analyze financial statements to identify trends, risks, and opportunities for improvement. o Collaborate with stakeholders to understand and refine model assumptions. o Maintain expertise in asset-based lending environments and borrowing base certificates. Education/Experience: Bachelor's degree in Finance or a related field, with five (5+) years of experience of progressive finance experience. (Master's degree preferred) Licensing and Certifications: Certified Public Accountant (CPA) optional Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 20 1bs.), standing, sitting and walking throughout the facility.

The Project Manager provides overall management of projects within TRC. The project manager will focus on company projects as they impact all departments, as well as future TRC business. The role will ensure projects are defined and managed in a clear and concise manner so that all participants, including managers, team members, and vendors, understand the project expectations, resources, and timelines. Responsibilities: Ensures a uniform definition of all company projects including objective, scope, approach, members, responsibilities, and timelines. Establish and maintain project schedules and report any variances as soon as recognized. Establish and maintain internal/external meeting agendas and minutes. Understands and assists teams identify critical path to ensure efficient and timely project success. Ensures and promotes multi-departmental communication required for cross functional projects. Identifies and assesses project impact to all departments as well as future company goals. Reports project information that may impact timelines, cash flow, product quality, resources, and other relevant information. Support organizational Project Management Office (PMO) processes/projects as needed. Qualifications: Bachelors in Physical Sciences, Engineering, Health Care, Life Sciences or Project Management or Associates Degree with ten (10) years of continuous working experience in Pharmaceuticals. 3-5 years project management experience in Pharmaceutical CDMO/CMO industry with PMP Certification preferred. Knowledge of project management tools and techniques including Six Sigma desired. Knowledge of cGMP and CFR Guidelines. Strong interpersonal/group written and verbal communication skills.

Apply Description Job Purpose: Secondary Packaging Maintenance Technicians are responsible for repairing, maintaining, troubleshooting issues on the Packaging machines and documenting all work while adhering to all safety procedures. Essential Duties and Responsibilities: Perform preventative maintenance on automated packaging lines Ensuring procedures are followed when performing maintenance. Perform electrical and mechanical maintenance on fully automated equipment. Ability to troubleshoot a variety of equipment and problem solving skills Use time management wisely and effectively Maintain and /or repair of conveyors, gear boxes, motors, inkjet printers, sensors and robotics. Daily production line walkthroughs to ensure problems are caught before production demands are jeopardized. Complete On the Job Training in a timely manner Ability to follow cGMP's and good documentation practices. Communicate with a daily pass down to other members of maintenance, production and management Supplemental Functions: Work under the direction of Secondary Packaging Shift Maintenance Lead. Assure the efficient performance of all department equipment. Assist with housekeeping as needed. Adhere to GMPs and hold those around them accountable. Education/Experience: NOTE: The primary accountabilities and knowledge, skills and abilities listed are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed below. Specific tasks or responsibilities will be documented in the incumbents' performance objectives as outlined by the incumbents' immediate supervisor or manager. High school diploma or 2 years minimum of electrical or mechanical maintenance in a manufacturing/production environment. Knowledge of the Pharmaceutical Industry preferred Must pass a Drug Test. Must speak, write, and read English. Specific expertise, skills and knowledge within maintenance gained through education and experience. The ability to take strategic objectives and accept accountability to drive results through effective actions. The ability and willingness to change direction and focus to meet shifting organizational and business demands. The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. The ability to create new products and processes that add value to the Business by generating new ideas and applying creative and analytical approaches. Position requires lifting (up to 50lbs), bending, climbing, reaching, good vision, standing, sitting, walking, gripping, talking, and hearing. Incumbents required to wear safety glasses, hearing protection and other non-specified protective equipment as necessary. Salary range: Based on experience 12 Hours Shifts, Days or Nights, Must be flexible to work across all shifts Available to work on-call per managements request. Working Conditions/ Physical Requirements: Position requires lifting (up to 50lbs), bending, climbing, reaching, good vision, standing, sitting, walking, gripping, talking, and hearing.

Apply Description Job Purpose: Quality Operations Clean Room Technicians Tier I are to monitor filling operations in compliance with company policies and Standard Operating Procedures, as well as FDA and cGMP regulations. Qualified individuals will be responsible to ensure the accuracy and completeness of batch records, and perform personnel monitoring, general operations filling in manual hoods, and other duties as necessary. Technicians will assist with additional work duties or responsibilities as evident or required. Essential Duties and Responsibilities: · Monitors aseptic techniques of personnel within the clean room. · Monitor Outsourcing filling operations within the clean rooms. · Verifies syringe filling rejects of Outsourcing products and performs quality attribute inspections as needed. · Maintains quality assurance documentation. · Review/sign appropriate sections designated for Pharmacist/QA designee signatures within the batch records. · Promotes teamwork both within the QA Team and other departments. · Monitors all filling areas and personnel for adherence to all cGMP, SOP's and safety regulations. · Keep line and work station clean and orderly to ensure no product line contamination. · Perform line clearance including equipment, components and label verification. · Perform room releases for filling rooms for Outsourcing areas. · Communicate quality - related observations, issues, problems, discrepancies and any violations of company policies or procedures to the Supervisor/Management. · Review all completed production batch record documentation to ensure completion and compliance. · Reviewing Logbooks for GDP and accuracy. · Performs general operation QA functions for manual filling processes. · Ability to perform personnel monitoring within the clean room. · Trained and authorized to enter samples into LabVantage. Supplemental Functions: · Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations. · Assist with development of solutions for chronic problems within quality assurance · Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management. · Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions. · Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed. · Assist in other activities (as needed) for Quality Assurance management. Knowledge & Skills: · Detail oriented. · Good computer skills in MS Outlook, MS Word, MS Excel, Internet, Email and basic typing skills. · Good visual acuity and observation skills. · Good written, oral and comprehensive communication skills. · Able to handle diversity of projects. · Specific expertise, skills and knowledge within quality assurance gained through education and experience. · A board perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities. · The ability and willingness to change direction and focus to meet shifting organizational and business demands. · The ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition. · The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. · Incumbents are required to wear hearing protection and other non-specified protective equipment as necessary. Education/Experience: · High School Diploma or GED · Minimum of 1 year of pharmaceutical Quality Assurance/Production experience or 2 years related experience preferred. Knowledge of GMP preferred. Working Conditions / Physical Requirements: · Position requires reaching (waist to head), bending (waist to floor), lifting (up to 25lbs), reaching (waist to head), vision (20/20), standing (40%), sitting (20%), walking (40%), typing and hearing.

Apply Description Job Purpose: The Sterile Filling Technician is responsible for performing aseptic filling and related sterile operations within a 503B outsourcing pharmaceutical manufacturing facility. This role ensures products are prepared, filled, and packaged in compliance with FDA 503B regulations, cGMP standards, and company SOPs to ensure product quality and patient safety. __________________________________________________________________________________________ Essential Duties and Responsibilities: Sterile Filling & Operations Ø Perform aseptic filling of injectable pharmaceuticals in cleanroom environments (ISO 5, ISO 7). Ø Operate and monitor sterile filling equipment (e.g., filling machines, cappers, and autoclaves). Ø Conduct manual and automated sterile filling processes according to batch records and SOPs. Ø Support environmental monitoring by maintaining strict aseptic technique. Ø Participate in line clearance, equipment set-up, in-process checks, and end-of-run reconciliation. Compliance & Documentation Ø Complete all batch records, logbooks, and electronic documentation in real time and with accuracy. Ø Adhere to FDA 503B regulations, cGMP, and internal quality policies. Ø Report deviations, non-conformances, or potential quality issues to supervision immediately. Ø Support regulatory inspections and internal audits as needed. Cleanroom & Equipment Maintenance Ø Follow gowning procedures and aseptic practices required for sterile areas. Ø Assist in cleaning, sanitizing, and maintaining cleanroom areas and equipment. Ø Perform equipment setup, operation, and minor troubleshooting under supervision. Teamwork & Continuous Improvement Ø Work collaboratively with Production Scheduling, Sterile Room, Quality, Microbiology, Engineering, and other Manufacturing teams to ensure smooth sterile production runs. Ø Participate in ongoing training programs to maintain qualifications for cleanroom operations. Ø Suggest process improvements to enhance efficiency, safety, and compliance. Supplemental Functions: Ø Performs all other duties as assigned or apparent. Job Specifications and Qualifications: Education / Experience: Ø High School Diploma or GED required; Associate or Bachelor's in Life Sciences preferred. Ø Minimum 1-2 years' experience in sterile pharmaceutical manufacturing, 503B outsourcing, or hospital compounding strongly preferred. Ø Familiarity with cGMP, FDA 503B guidance, and aseptic technique required. Skills & Competencies: Ø Strong knowledge of sterile gowning and aseptic technique. Ø Ability to work in controlled cleanroom environments. Ø Excellent attention to detail, documentation accuracy, and adherence to SOPs. Ø Strong teamwork and communication skills. Licensing and Certifications: Ø Registered Pharmacy Technician Certification Ø Ability to maintain Gowning Certification _____________________________________________________________________________ Working Conditions / Physical Requirements: Ø Work performed primarily in classified cleanroom environments with strict gowning requirements. Ø Ability to lift up to 40 lbs and stand for extended periods. Ø Requires routine handling of sterile materials, chemicals, and equipment. Ø Shift work, weekends, and overtime may be required based on production demands.

Apply Description Job Purpose: Secondary Packaging's main objective is to place primary packaged products into outer packaging that provides additional protection for distribution and retail. The secondary packaging process ensures the safe, compliant, and efficient transport of the pharmaceutical products. Essential Duties and Responsibilities: Monitor the operation of Secondary Packaging equipment to determine trends (i.e. vials per minute and pallets packaged per shift. Responsible for overseeing changeovers and end of lot procedures. Responsible for reconciliation in the MBR. Responsible for training new personnel on your shift. Responsible for starting, stopping and repairing minor problems with Secondary Packaging equipment. Initiate and manage any document, equipment, or process change related to non-conformance investigations as corrective/preventive action. Coordinate training sessions on new documents or processes. Ensure completion and implementation of CAPAs (corrective/preventive actions). Coordinate and update the daily packaging schedule in the absence of the Operations Manager. Initiate, create, and manage any document, equipment, or process change as delegated by Operations management. Writes or reviews manufacturing procedures and related document. Prepare and review internal documentations for management and production staff. Participates in internal GMP audits and supports customer and regulatory audit response. Assists with additional work duties or responsibilities as evident or required. Performs other duties as assigned or apparent. Supplemental Functions: · Work under the direction of the Director or designee. · Assure the efficient performance of all department equipment. · Assist with housekeeping as needed. · Adhere to GMPs and hold those around them accountable. Job Specifications and Qualifications: Knowledge & Skills: Knowledge of the Pharmaceutical of Manufacturing Industry preferred. Must be able to pass a Drug Test. Must speak, write, and read English. Specific expertise, skills and knowledge gained through education and experience. Ability to take strategic objectives and accept accountability to drive results through effective actions. Ability and willingness to change direction and focus to meet shifting organizational and business demands. Ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. Ability to create new products and processes that add value to the business by generating new ideas, applying creative, and analytical approaches. Ability to prioritize tasks, manage time efficiently, and meet deadlines. Familiar with relevant industry regulations and compliance standards. Incumbents required to wear safety glasses, hearing protection and other non-specified protective equipment as necessary. Strong critical thinking, analytical, problem-solving, and interpersonal skills. Strong organizational skills with the ability to manage multiple projects or assignments simultaneously. Education/Experience: High school diploma or equivalency is required. Prefer 2yrs of manufacturing or pharmaceutical experience but not required. Working Conditions / Physical Requirements: This position requires lifting (up to 50lbs), bending, climbing, reaching, good vision, standing, sitting, walking, gripping, talking, and hearing.

Job Purpose: Provide strategic and operational leadership for Quality Operations supporting aseptic manufacturing, including Blow-Fill-Seal (BFS) and conventional sterile filling processes. Ensure full compliance with FDA 503B regulations, cGMP requirements, and applicable regulatory standards by establishing, maintaining, and continuously improving robust Quality Systems. Oversee quality oversight of facilities, utilities, equipment, and environmental monitoring programs to ensure sterility assurance and a sustained state of control. Lead and develop a high-performing Quality Operations organization, fostering a strong culture of quality, data integrity, inspection readiness, and continuous improvement. Partner cross-functionally with Manufacturing, Engineering, and Supply Chain to enable compliant, efficient operations, ensure uninterrupted supply, and serve as the primary Quality representative during regulatory inspections and audits. Essential Duties and Responsibilities: * Provide Quality Operations leadership for aseptic manufacturing, including Blow-Fill-Seal (BFS), conventional sterile filling, visual inspection, and secondary packaging operations. * Ensure compliance with FDA 503B regulations, cGMP requirements, and data integrity standards across all manufacturing and quality activities. * Own and maintain site Quality Systems, including deviations, investigations, CAPA, change control, complaints, and document control. * Provide Quality oversight and approval for batch record review, product disposition, validation activities, and aseptic process controls. * Support sterility assurance programs, including environmental and utilities monitoring, contamination control strategy, and aseptic process simulations. * Lead inspection readiness and serve as the primary Quality representative during FDA, customer, and regulatory audits. * Partner with Manufacturing, Engineering, and Technical Services to support equipment qualification, process changes, capital projects, and technology transfers impacting filling, inspection, and packaging operations. * Lead, develop, and mentor the Quality Operations team while driving a strong culture of quality, compliance, and continuous improvement. * Oversee Quality review and approval of facilities, utilities, and equipment qualification, calibration, maintenance, and lifecycle management activities. * Establish and monitor Quality metrics and KPIs to assess performance, identify trends, and drive continuous improvement initiatives. * Lead, coach, and develop the Quality Operations team, ensuring appropriate staffing, training, and succession planning. * Ensure effective supplier quality management, including qualification, audits, and oversight of critical vendors and contract service providers. * Review and approve procedures, protocols, reports, and quality agreements to ensure regulatory compliance and operational alignment. * Drive a culture of quality, accountability, and continuous improvement across the site. * Escalate quality risks appropriately and ensure timely, effective mitigation to protect patient safety and product quality. Knowledge & Skills: * Comprehensive understanding of FDA regulatory frameworks covering both 503B Outsourcing Facility requirements and cGMP operations, including 21 CFR Parts 210/211 and applicable guidance documents. * Strong expertise in sterility assurance, aseptic processing, environmental monitoring, and contamination control strategies within sterile manufacturing, visual inspection, and secondary packaging. * Experience leading FDA inspections, regulatory audits, and customer audits, with strong inspection readiness and response capabilities. * Proven ability to apply quality risk management principles and data-driven decision-making to ensure product quality and patient safety. * Strong leadership, coaching, and organizational development skills, with the ability to build and sustain high-performing Quality teams. * Effective cross-functional collaboration skills, partnering with Manufacturing, Engineering, Technical Services, and Supply Chain. * Experience with change control, deviation investigations, and CAPA systems within a GMP-regulated manufacturing environment. * Experience with quality approval for process validation and equipment qualification (IQ/OQ/PQ), media fills, cleaning validation, and lifecycle process management. * Proficiency with quality metrics, KPIs, and continuous improvement methodologies to drive compliance and operational excellence. * Strong leadership capabilities with experience coaching and developing high-performing teams across operations and quality. * Prior experience supporting regulatory inspections (FDA, state board of pharmacy, or third-party audits). * Must be detailed oriented and have excellent organizational skills. * Must have excellent communication and technical writing skills. * Ability to drive continuous improvement initiatives while maintaining regulatory compliance and quality standards. * Strong organizational skills with the ability to manage multiple priorities in a fast-paced, regulated environment. Education/Experience: * Bachelor's degree in Engineering, Life Sciences, Pharmacy, Chemistry, or a related scientific/technical discipline required. * Minimum of 10+ years of progressive experience in Quality Assurance / Quality Operations within a cGMP-regulated pharmaceutical or biotechnology environment. * At least 5+ years of leadership experience managing Quality teams supporting sterile manufacturing operations. * Hands-on experience with aseptic processing, visual inspection, and secondary packaging. * Proven experience overseeing Quality Systems such as deviations, investigations, CAPA, change control, and document control. * Experience supporting equipment qualification, process validation, environmental monitoring, and sterility assurance programs. * Strong background in inspection readiness, audit management, and regulatory interactions. * Hands-on experience supporting FDA inspections, regulatory audits, and responses to inspection observations (e.g., FDA Form 483). * Strong background in operational excellence, continuous improvement, and performance management. * Demonstrated ability to lead cross-functional teams while maintaining Quality unit independence and regulatory compliance. * Salary Range: Based on experience Working Conditions / Physical Requirements: * Position requires bending, typing, climbing, lifting, reaching, vision, standing, sitting (10%), walking, and hearing.

Multi-Craft Technician will maintain and trouble-shoot equipment within the manufacturing department. The technician will be fully trained in the operation of all manufacturing equipment before being trained specifically on the technical maintenance and repair Standard Operating Procedures (SOP's). Responsible for electrical and mechanical troubleshooting of fluid delivery, extrusion, hydraulic, electrical, mechanical, and conveyance systems in a clean room manufacturing environment. The technician will be required to maintain Operating Technician proficiency and in case of emergency, may be required to assist starting and ending of batch processing. Also, required to provide rebuilding of miscellaneous cylinders, valves, pumps, etc. Responsibilities: • Maintain Operator-Level training status for all departmental equipment. • Maintain Multi-craft Technician training status for all technical work instructions and SOP's. • Perform preventive maintenance as well as trouble-shooting on all equipment. • Provide detailed documentation of work completed, parts used, and shift summary. (Microsoft Office / CMMS) • Use of the Computerized Maintenance Management System for writing work orders and pulling parts from stock. • Read schematics and equipment manuals on a daily basis for trouble-shooting and procuring proper replacement parts. • Perform routine shift checks of production equipment and document appropriately. • Make technical adjustments to extrusion, molding, and filling systems as needed to maintain process control. • Be available to perform and assist with emergency maintenance as required. • Maintain compliance with all gowning, environmental monitoring, and personnel monitoring requirements. • Be able to work efficiently in finding value-added activities on a daily basis without close supervision. • Follow written and verbal procedures as directed by the area leadership team. • Follow Standard Operating Procedures, good housekeeping practices, cGMP and health/safety guidelines. Physical Requirements: • Ability to frequently lift and carry up to 70 pounds of equipment, parts or supplies. • Ability to ascend or descend machinery using feet, legs, hands and arms up to 8 feet high. • Ability to maneuver into, around and out of machinery with limited access space. Qualifications • 2 year technical degree or equivalent experience in a technical manufacturing maintenance environment. • Mechanical and electrical experience in a manufacturing environment is preferred. • Ability to diagnose and repair hydraulic, fluid delivery, controls, extrusion, and 3-phase electrical systems. • Ability to read mechanical, electrical, and hydraulic schematics to trouble shoot and repair these systems as required.