Quality Systems Manager jobs at Biolife Plasma Services

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Quality Control Manager to join our talented team at our office located in Cary, North Carolina. In this role, you will use your technical knowledge and skills to effectively train, supervise, communicate, execute, and manage the IPS Construction Quality Control and Quality Assurance (QA/QC) program for ongoing Construction Projects. This is a leadership role responsible for working with the On-Site Construction Management Team to ensure the established project standards are followed. Additional Responsibilities Develops, plans, manages, and administers the implementation of project-specific Construction QA/QC Plans with the CM team, contractors, and clients. Trains the project team on their criteria and implementation. Develops special Inspection Test Plans and System Completion records that will be incorporated into the QA/QC project-specific plans. Reports and publish quality reports, audits, and initiatives to the Project Manager and review with the project team prior to publication. Ensures Corporate Quality initiatives and goals are achieved. Develops a system to compile, monitor, track, and confirm deficiencies and successes of work performed by direct-hire and subcontract work crews. Evaluates testing, sampling methodologies, technologies, and equipment to confirm correct applications are implemented. Reviews utility matrices developed to start up and commission systems and skids. Directs the tracking of deficiencies, test results, or other regularly reported quality control data. Manages non-conformance reporting activities and tracks efficiencies from identification through resolution. Monitors performance of quality control systems to ensure effectiveness and efficiency. Verifies that the construction of systems and equipment are installed in accordance with approved construction documents. Reviews plans and specifications to ensure requirements are met for each construction process. Understand and apply federal, state, and local codes, policies, laws, and regulations. Identifies quality problems or areas for improvement and recommends solutions. Assists in performing system walk downs/final inspections; closeout and startup; establishes system completion punch list items; and, ensures all deficiencies are corrected. Attends pre-construction and construction meetings noting areas/topics that may present future problems/risks and present to the project manager for consultation. Implements the corporate safety culture and principles into the QA/QC programs. Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights! Qualifications & Requirements B.S. in a Science, Engineering, Construction management, or related field. Quality Assurance and Quality Control Management training and experience with 15 years of field experience in construction and/or engineering. Strong knowledge of applicable regulatory guidelines within the construction safety and pharmaceutical industry along with the ability to interpret complex issues and provide recommended courses of action. Proficient skill level in Microsoft Office Suite. Preferred Qualifications First Aid/CPR training. Primavera P6 and MS Project knowledge. Commissioning and System startup experience. Safety You will travel 50% of the time, or as necessary to complete duties. You may be assigned to a client for an extended period of time (1-2 years). OSHA 10 certification (IPS will provide tools) must be maintained during employment. Overnight travel is possible. You will focus on construction field activity and office time will be limited. You will visit Client sites and will be required to adhere to stated safety rules. This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas All interviews are conducted either in person or virtually, with video required. About Us IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do. Specialties Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services. All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer. Connect With Us! If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!

STAQ is currently hiring for a Quality Control Manager in the Denver area Monday to Friday, 8 AM to 5 PM Salary: $105K-$110K/year STAQ Pharma is a 503B Outsourcing Facility located in Denver. STAQ Pharma produces sterile injectable medications for adults and pediatric patients, compounded under cGMP standards. STAQ's ownership and board are composed of large hospital systems ensuring the priority focus remains on delivering needed medications in a safe and timely manner. We are looking for exception people to join the STAQ team. This role is responsible for leading all Quality Control (QC) activities at the site. The QC Manager will encourage and motivate associates to be successful and focused on Safety, Transparency, Availability, and Quality (STAQ) objectives. Roles and Responsibilities Establish an environmental monitoring program for the facility utilizing a risk-based approach to new and existing procedures. Develop, manage, and improve QC processes and procedures to ensure compliance with all applicable laws, regulations, and STAQ Quality standards in support of cGMP standards for pharmaceutical manufacturing (503B). Prepare, review, manage, and approve controlled documents (SOPs, protocols, logbooks, reports, etc.) relevant to STAQ QC operations. Lead and draft investigations/deviations/change controls/OOS/CAPAs as they relate to environmental monitoring or Quality Control deviations. Provide expertise and support to the Operations, Regulatory, and Quality teams. Subject matter expert during audits or inspections as it relates to microbiology/environmental monitoring. Recruit, retain, and mentor direct reports to comprise the QC team. Promote personal and professional growth of team members. Support the batch disposition process including management of reserve samples and QC samples for batch release testing. Manage the budget for the QC Lab department to meet financial objectives. Lead the Stability Program including study management, protocol development & evaluation, timely completion of stability tests, data trending, etc. Collect, submit, ship, and manage appropriate raw material, microbiological and finished goods samples to third party testing laboratories. Coordinate and facilitate operations within the internal laboratory to ensure Environmental Monitoring samples are performed, tested, reviewed, and trended appropriately. Conduct routine and non-routine viable, non-viable and surface environmental monitoring in all classified areas of the facility. Analyze and interpret trends and identify opportunities to improve processes and achieve state of control. Focus on responsiveness, ability to multi-task, attention to detail, effective problem-solving skills, consistent follow-up, and ability to make timely and sound decisions. Implement methods of continuous improvement in daily work and in evaluation of company processes and performance. Other duties as assigned. Preferred Qualifications and Education B.S. or B.A. in Microbiology or a closely related field / or equivalent experience. Minimum five (5) years' experience in a quality control environment. Experience in a cGMP pharmaceutical/aseptic manufacturing environment. Must demonstrate understanding and/or working knowledge of regulations/guidelines such as FDA, USP, ICH, etc. Proficiency/experience with environmental monitoring program for aseptic manufacturing facility, including personnel monitoring, and qualification program. Preferred Experience and Skills Working knowledge of aseptic/sterile manufacturing techniques. Ability to coordinate multiple priorities in a fast-paced environment. Strong communication skills with the ability to interact with all levels across the organization. Demonstrated excellent interpersonal skills and flexibility. Familiarity with 21 CFR Part 11/210/211. Additional Notes Join a dynamic team at the leading edge as we build out a new 137K sq. ft. manufacturing facility. This position will work closely with cross functional teams and report quality data to the department heads for each team, as needed Timeline: We will be accepting applications on an ongoing basis until position is filled.

GxP Quality Auditor / Senior Quality Lead Employment Type: Full-Time, On-Site Salary Range: $87,780 - $145,307/year A leading life sciences organization is seeking a GxP Quality Auditor / Senior Quality Lead to support compliance and quality governance across multiple manufacturing lines. This company partners with global pharmaceutical and biotech firms to deliver solutions that ensure regulatory excellence and operational integrity. Position Summary The GxP Quality Auditor / Senior Quality Lead will play a critical role in maintaining compliance with global regulatory standards and driving quality initiatives. This position requires expertise in pharmaceutical compliance, bracketing strategies, and regulatory interpretation in a GMP-regulated environment. Key Responsibilities Coordinate between site and global teams to align SOPs and bracketing strategy Provide regulatory and technical interpretation to ensure compliance with FDA, EMA, and HMRA requirements Develop and defend bracketing justification for multiple manufacturing lines and isolators Facilitate governance meetings, escalate risks, and report status to leadership Review and approve protocol templates, summaries, and reports for finalization Qualifications Bachelor's degree in a scientific or industry-related field Minimum 7+ years of experience in pharmaceutical manufacturing or compliance Proven experience developing bracketing and matrixing strategies Strong knowledge of FDA, EMA, and HMRA regulations Familiarity with cGMP and facility/equipment validation requirements Excellent technical writing and communication skills Ability to work full-time on-site in Greenville, NC Why Join This Team? Competitive compensation and performance-based incentives Comprehensive benefits package including medical, dental, vision, and retirement plans Paid time off, holidays, and professional development opportunities Collaborative culture with strong career growth potential

JOB PURPOSE : Responsible for the staffing, organization, operation, budget, and maintenance of all activities related to QA monitoring of production activities, assuring that materials and products are inspected and released in compliance with cGMP guidelines, USP and FDA, EU requirements. Responsible for first shift QA In-Process and In-coming Groups, getting all the QA batch record documents approved for timely release of finished products and timely release of incoming materials. Work closely with Operations (Filling and Packaging) and other groups as necessary to troubleshoot issues in the warehouse, filling and packaging floors and ensure timely reporting of events. Work closely with compliance group at times of external audits (FDA or vendors). Ensure that non-compliant situations are thoroughly investigated. KEY ACCOUNTABILITIES: Regular and predictable onsite attendance and punctuality. Directs the incoming and in-process QA groups. Makes final accept/reject disposition on incoming materials, including but not limited to raw materials, components, production commodities. Assures batch is manufactured Ensures that records are reviewed and released in a timely manner. Coordinates communication for status of incoming materials and resolves issues related to accept/reject disposition of materials. Coordinates communication of production status to next shift; attends daily update meetings as required. Manages personnel for in-process filling and inspection/packaging monitoring. Provides QA review and approval of manufacturing investigations, as necessary, assuring timely review, follow-up, tracking and trending of MIRs. Provide guidance to the investigator, as required Reviews and approves SOPs, Job-Aids, Specifications, FMEA documents, Change Controls and Validation documents (Protocols, GTR's, Commissioning Documents, FAT's), engineering documents. Expedites and prioritizes product releases by coordinating the Review of QA documentation to meet customer service requirements. Conducts routine investigation and departmental meetings to facilitate the performance of release function, with respect to incoming materials. Develop and implement Quality Systems Improvements through participation in cross functional teams. Performs and/or assures cGMP and technical training for and certification of staff. Places lots on HOLD if Quality issues are detected and notifies senior management. Assists the QA management in developing on department budget. Attends interdepartmental meetings representing Quality Assurance and makes sound quality decisions. Manages attendance records for all direct reports. QUALIFICATIONS: College Degree within a science related discipline such as a B.S. in Pharmacy, Science, Engineering or other related fields is required with 10+ years' experience, or Masters' Degree in Microbiology, or biological science with 3-6 years' experience Ph.D. in relevant field with 0-3 years' experience Preferred: Additional college courses in Microbiology, cGMPs, Statistics or Quality Management are beneficial EXPERIENCE: Minimum: Experience in the Pharmaceutical Industry in the field of Quality Assurance or Production is a must SKILLS: Must have history of strong documentation skills and attention to detail Familiarity with cGMPs and CFR for US and EU Excellent organizational skills and ability to multi-task and perform work in a timely manner Demonstrates ability to lead a department, projects and meetings effectively Ability to work in a team environment with good communication skills and ability to communicate effectively with peers, and senior management General computer skills and ability to prepare presentations and address large groups Demonstrated attention to details and accuracy The incumbent must possess the strong knowledge of quality assurance systems. Dealing with FDA, third party during inspection is a must Mentoring abilities as well as effective communication, (written and oral) are required. What We Offer*: Annual performance bonus, commission, and share potential Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave *Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms. Equal Opportunity Employer: Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Alexander Technology Group is looking for a Quality Engineer for a client based in the Portsmouth, NH area. This is full-time (perm) On-site in Portsmouth, NH Key Responsibilities: Develop and maintain quality systems for combination products. Ensure compliance with FDA, ISO 13485, cGMP, and other standards. Lead risk assessments, root cause analyses, and corrective actions. Oversee testing, validation, and documentation processes. Collaborate with R&D, manufacturing, and regulatory teams. Conduct training on QA practices and support continuous improvement. Perform inspections and product testing to ensure quality standards. Qualifications: Bachelor's in Engineering, Life Sciences, or related field. Strong knowledge of regulatory requirements and quality tools (e.g., Six Sigma, CAPA, FMEA). Excellent problem-solving and communication skills. Able to work independently in a small team environment. Preferred: Experience with design control, eQMS, and statistical tools. ASQ CQE certification. 3+ years in QA/QE roles with combination products. If interested, please send resume to ************************

The Global Quality Large Molecule Analytical Sciences (GQLMAS) team is responsible for the establishment and performance of commercial large molecule analytical techniques, including method development, validation, troubleshooting, transfers as well as stocking and supplying critical reagents to global laboratories. We collaborate with both internal teams and outsourced partners. Our team is fast paced, highly motivated, and focused on advancing our Company's large molecule pipeline as well as supporting growth and performance of existing licensed products. Specific job responsibilities could include analytical method development, troubleshooting, validation, sample testing supporting process development/changes, and logistical support for sample management and shipments, all while providing hands-on experience in a GMP environment. Interested candidates should have the following Experience with pipettes, balances, pH meters, biosafety cabinets, and/or fume hoods. Experience with documenting experimentations including objectives, reagents, procedure, results, and conclusions. Experience in one or more of the following analytical laboratory techniques: Cell culture techniques: mammalian cell culture, cell-based assays, virus plaque, virus TCID50, Attribute testing: ELISA, BCA, Bradford, UPLC/HPLC, cIEF, CE, LC-MS, UV-Vis, DLS, MALS/RI, CCIT, ICP-MS Microbial techniques: kinetic turbidimetric/chromogenic, sterility, environmental monitoring, microbial limits testing Or interest in learning logistics of Good Manufacturing Practices (GMP) sample movement. Ability to work independently and within a cross-functional teams. Ability to learn new techniques. Good technical, communication (oral and written), interpersonal, and teamwork skills. Required Education and Experience: Candidates must be currently working toward B.S. in Biology, Biochemistry, Chemistry, Logistics or a related field. Education Minimum Requirement: Minimum of three (3) years in a BS -OR- in a MS program in one of the following disciplines: Biology Biochemistry Chemistry Molecular Biology Virology Logistics Candidates must be successful candidates will possess strong interpersonal and writing skills, with attention to detail and the ability to work independently. Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company. Salary range: The salary range for this role is $39,600.00-$105,500.00 USD MD2026 FTP2026 Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Intern/Co-op (Fixed Term) Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Required Skills: Assay, Assay, Biochemistry, Business, Cell-Based Assays, Cell Cultures, Clinical Research, Cloud Data Catalog, Communication, Data Analysis, Database Management, Data Science, Data Security, Data Visualization, Data Wrangling, Detail-Oriented, Event Planning, GMP Compliance, Immunochemistry, Key Performance Indicators (KPI), Laboratory Techniques, Mammalian Cell, Mammalian Cell Culture, Molecular Biology, Production Process Development {+ 5 more} Preferred Skills: Job Posting End Date: 11/3/2025 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Nature and Scope Reporting to the, QA Operations & Quality Systems Director, the QA Release Senior Manager focuses on final release of all components, materials, and products utilized and produced at American Regent sterile manufacturing plants and laboratories. This position is also responsible for oversight of activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and their adherence to established Quality and Compliance requirements. This is a multi-disciplinary management role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at three different American Regent sites in the Columbus, Ohio area. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. * Manage and assign QA staff in incoming, in-process, final inspection, and batch release. Includes the inspection & sampling of raw materials, finished products, and components. Is directly responsible for batch releases. * Oversee GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. * Ensures oversight for the successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners. * Act as a liaison between QA and other departments on quality issues related to release of incoming, in-process, and final products and report back to the QA Operations & Quality Systems Director. * Initiation, review and approval of cGMP documentation including: procedures, policies, change controls, deviations. * Develop and manage quality metrics to optimize performance, identify trends, and communicate to Senior level Management. * Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel. * Identifies and resolves potential cGMP issues which may impact quality and reports results to Senior level Management. * Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. * Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements in the markets where product is sold. * Ensures Quality Assurance goals and objectives are identified and met * Act as a liaison between American Regent QA and third-parties on quality issues and report back to the QA Operations & Quality Systems Director * Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * Bachelors' degree in Life Science or equivalent course of study is required. * 10 years progressive experience in QA Pharmaceutical environment required. * 5-10 years management experience required. * Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices. * Excellent oral and written communication skills including strong technical writing skills. * Strong organizational skills, planning skills and team-building. * Ability to work independently and deliver timely results. * Ability to lead cross functional teams, resolve conflicts and disagreements. * Ability to travel between each of the Ohio facilities (in the greater Columbus area). American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: * All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. * Our recruiting process includes multiple in person and/or video interviews and assessments. * If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. * We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope Reporting to the, QA Operations & Quality Systems Director, the QA Release Senior Manager focuses on final release of all components, materials, and products utilized and produced at American Regent sterile manufacturing plants and laboratories. This position is also responsible for oversight of activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and their adherence to established Quality and Compliance requirements. This is a multi-disciplinary management role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at three different American Regent sites in the Columbus, Ohio area. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. Manage and assign QA staff in incoming, in-process, final inspection, and batch release. Includes the inspection & sampling of raw materials, finished products, and components. Is directly responsible for batch releases. Oversee GMP activities of Contract Manufacturing Organizations (CMO) finished product manufacturing and ensuring conformance to established Quality and Compliance requirements. Ensures oversight for the successful life cycle development and commercialization of pharmaceuticals at external manufacturing partners. Act as a liaison between QA and other departments on quality issues related to release of incoming, in-process, and final products and report back to the QA Operations & Quality Systems Director. Initiation, review and approval of cGMP documentation including: procedures, policies, change controls, deviations. Develop and manage quality metrics to optimize performance, identify trends, and communicate to Senior level Management. Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel. Identifies and resolves potential cGMP issues which may impact quality and reports results to Senior level Management. Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. Ensures all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements in the markets where product is sold. Ensures Quality Assurance goals and objectives are identified and met Act as a liaison between American Regent QA and third-parties on quality issues and report back to the QA Operations & Quality Systems Director Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Bachelors' degree in Life Science or equivalent course of study is required. 10 years progressive experience in QA Pharmaceutical environment required. 5-10 years management experience required. Strong working knowledge of Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices. Excellent oral and written communication skills including strong technical writing skills. Strong organizational skills, planning skills and team-building. Ability to work independently and deliver timely results. Ability to lead cross functional teams, resolve conflicts and disagreements. Ability to travel between each of the Ohio facilities (in the greater Columbus area). American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: · All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. · Our recruiting process includes multiple in person and/or video interviews and assessments. · If you are unsure about the legitimacy of a message, contact John Rossini at *************************** before responding. · We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make *********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. Lonza Pharma & Biotech is looking for a Manager, QA Compliance & Validation to join our Quality Assurance team in Bend, OR. This is an exciting opportunity to lead a high-performing QA team and ensure compliance across pharmaceutical development and manufacturing. Your work will help shape processes that improve lives worldwide. What you will get An agile career and dynamic working culture. An inclusive and ethical workplace. Competitive compensation programs that recognize high performance. Medical, dental, and vision insurance. Access to global benefits: *************************************** Key Responsibilities: Support internal and external audits and regulatory inspections as a QA expert. Train staff on cGMP and regulatory standards. Oversee compliance evaluations for development and manufacturing activities. Identify and validate corrective and preventive actions (CAPA). Develop workflows and compliance metrics to improve efficiency. Supervise QA staff and manage quality systems documentation. Review and approve regulatory documents. Key Requirements: Bachelor's degree or equivalent experience. Significant experience in the pharmaceutical or biotech industry. Strong compliance and regulatory knowledge. Prior management experience with leadership skills. Familiarity with GMP (Good Manufacturing Practices) preferred. Excellent communication and collaboration skills. Ability to work independently and as part of a team. Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Build your best future with the Johnson Controls team Join a culture that prioritizes your physical, financial, and emotional wellbeing. At Johnson Controls, your voice and ideas are valued, and your next great opportunity awaits! The North American Chiller organization is a growth engine for Johnson Controls seeing robus growth year over year. What we offer: Competitive salary and bonus Paid vacation/holidays/sick time Comprehensive benefits package including 401K, medical, dental, and vision care On-the-job/cross training opportunities Encouraging and collaborative team environment Commitment to safety through our Zero Harm policy This role is eligible for relocation to our New Freedom, PA facility What you will do You will play a pivotal role responsible for leading the successful launch of innovative chiller products throughout North America. This position demands a strategic leader who will coordinate a geographically diverse team of NPI Engineers in Mexico and the USA. As the central point of contact for vital cross-functional collaboration, the NPI Manager will work closely with Engineering, Manufacturing, Supply Chain, Quality Assurance, and Product Management teams to ensure that all new products fulfill performance, cost, and quality metrics while adhering to strict project timelines and compliance requirements. How you will do it Direct and oversee the complete lifecycle of NPI programs from initial concept development to production ramp-up, ensuring alignment with business objectives and customer expectations. Manage and mentor a team of three NPI Engineers, providing technical guidance, support on project milestones, and professional development to enhance team capabilities. Utilize Advanced Product Quality Planning (APQP) methodologies, including Failure Mode and Effects Analysis (FMEA), Control Plans, Production Part Approval Process (PPAP), and Process Capability Studies to ensure robust product and process design. Lead the creation and validation of labor routings, material summaries, and tooling requirements necessary for pilot and production builds, ensuring operational efficiency. Collaborate with the Program Management Team, Product Line Managers, Engineering, Operations, Supplier Management, and other stakeholders to ensure product launch success and compliance with ISO 9001, IATF 16949, and internal quality standards. Monitor and analyze Key Performance Indicators (KPIs), manage potential risks, and drive resolutions to maintain project progress and meet launch deadlines. Integrate Voice of the Customer (VOC) feedback into product validation processes to ensure alignment with market and customer needs, enhancing overall product acceptance. What we look for Strategic Thinking: Proactively identifies challenges and develops solutions aligned with long-term business objectives. Influence and Collaboration: Cultivates relationships across various functions and regions, fostering consensus within a matrixed environment. Accountability: Takes ownership of project outcomes and promotes a culture of responsibility and continuous improvement. Communication: Delivers clear and effective communication to diverse stakeholders, bridging technical and non-technical aspects at all organizational levels. Adaptability: Excels in dynamic environments, adjusting strategies to meet shifting business needs and priorities. Cultural Awareness: Exhibits sensitivity and effectiveness in leading a multicultural team across North America. University degree or equivalent combination of education and experience. 8 Years suggested minimum experience. Performance Metrics: Field Quality Performance of new products, particularly during installation and initial deployment phases. Manufacturing First Pass Yield, reflecting the quality performance during initial production runs. Average Issue Resolution Time, ensuring timely management of critical issues during development and launch phases. Preferred: Quality Management Systems Auditor certification (ISO 9001 or IATF 16949 preferred) Bilingual in English and Spanish is a strong plus Lean Six Sigma Certification (Green Belt or higher) Project Management Professional (PMP) Certification or equivalent APQP/PPAP Training Certification FMEA and Risk Management Certification Proficiency in Quality Software Tools (e.g., Minitab, Q-DAS, Windchill) HIRING SALARY RANGE: $97,000-130,000+ (Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, location and alignment with market data.) This role offers a competitive Bonus plan that will take into account individual, group, and corporate performance. This position includes a competitive benefits package. For details, please visit the About Us tab on the Johnson Controls Careers site at ***************************************** #LI-onsite Johnson Controls International plc. is an equal employment opportunity and affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, genetic information, sexual orientation, gender identity, status as a qualified individual with a disability or any other characteristic protected by law. To view more information about your equal opportunity and non-discrimination rights as a candidate, visit EEO is the Law. If you are an individual with a disability and you require an accommodation during the application process, please visit here.

About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA 3900 Duckhorn Dr, Sacramento, CA 95834 About the Job: Title of the Position: Quality Assurance Manager-Parenteral (Full Time) At Nivagen as Quality Assurance manager you will be responsible for overseeing and managing all QA activities related to the manufacturing of sterile injectable (parenteral) products. This includes ensuring compliance with cGMP regulations, internal quality standards, and applicable regulatory requirements (e.g., FDA, EMA, MHRA). The QA Manager will lead a team in managing quality systems such as deviations, CAPAs, change control, batch release, validation oversight, and audit readiness. The role requires close collaboration with production, QC, regulatory affairs, and engineering teams to ensure consistent product quality and continuous improvement. Responsibilities: Perform on-the-floor QA tasks within the manufacturing areas as needed, collaborating with manufacturing and other departments to provide routine quality support, and maintain inspection readiness. Provide triage support across departments to address moderate quality issues, ensuring timely escalation to management when necessary. Review and approve deviations, including the associated investigation reports, and corrective/preventative actions. Review and approve change controls for appropriateness, completeness and alignment with quality, validation, and regulatory expectations. Review and approve sampling protocols, risk assessments, and master batch records. Author, review and approve SOPs as appropriate for both Operations and Quality. Assist with additional tasks, including (but not limited to) Master Data management / approval, GMP area walkthroughs, product changeover activities. Participate in internal audits, support regulatory inspections or customer audit activities, as needed. Maintain and update quality-related documents, records, and reports within the quality management system (QMS), ensuring accuracy, consistency, and regulatory compliance. Assist in the development or assignment of training to key stakeholders related to QMS. Contribute to the preparation of Periodic Quality Reviews. Assume responsibility for any additional quality-related activities delegated to the hub, ensuring effective management in alignment with Quality standards. Support the implementation of a quality culture and best practices within the affiliate organization Qualifications: Education/Experience: Candidates with a Bachelor's degree must have at least 10 years of relevant experience; those with a Master's degree require 5+ years of experience. Strong background in manufacturing and quality assurance within the pharmaceutical or biotechnology industry is essential. Knowledge, Skills, and Abilities: Knowledge of cGMPs, Production Processes, Quality Systems, and FDA regulations Knowledge of current Good Manufacturing Practices and the applicable GxP regulations and standards. Proactive approach and strong critical thinking skills. Must be able to work in a team environment within own team and interdepartmental teams. Excellent communication and interpersonal skills. Experience in quality administered systems. Strong organizational skills and attention to detail. Experience with regulatory compliance and documentation. Ability to mentor and review the work of other colleagues. Knowledge of electronic systems such as Compliance wire., Veeva, Track wise, SAP, LIMS, Maximo, Microsoft Office etc. Job Requirements: This role is primarily day shift, Monday - Friday, with 24/7 support of manufacturing as quality issues arise. Good judgment and correct decision making based on company procedures/standards, technical experience, and industry guidance / regulatory requirements. Collaboration skills and the ability to independently engage with a wide range of colleagues, and management to gather the input and background knowledge needed to complete assignments. Must be able to gown for entering controlled areas. Must be able to wear specialized protective clothing, wear PPE (safety shoes/glasses/etc.). Flexibility is required as work hours and starting times may vary to provide coverage on different shifts to meet business needs. Overtime and weekend work may be required. Individuals must be available via cell phone (on-call). Must live or be willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: Pay range $85,000-$95,000 per Year / $40/hr. (for hourly basis) Relocation assistance available Annual bonus Eligibility (Based on yearly company and personal performance) Medical, dental and vision coverage Paid time off plan 401k savings plan with No matching Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

7,000 Diseases - 500 Treatments - 1 Rare Pharmacy PANTHERx is the nation's largest rare disease pharmacy, and we put the patient experience at the top of everything that we do. If you are looking for a career in the healthcare field that embraces authentic dedication to patient care, you don't need to look beyond PANTHERx. In every line of service, in every position and area of expertise, PANTHERx associates are driven to provide the highest quality outcomes for our patients. We are seeking team members who: Are inspired and compassionate problem solvers; Produce high quality work; Thrive in the excitement of the ever-challenging environment of modern medicine; and Are committed to achieving superior health outcomes for people living with rare and devastating diseases. At PANTHERx, we know our employees are the driving force in what we do. We cultivate talent and encourage growth within PANTHERx so that our associates can continue to explore their interests and expand their careers. Guided by our mission to provide uncompromising quality every day, we continue our strategic growth to further reach those affected by rare diseases. Join the PANTHERx team, and define your own RxARE future in healthcare! Location: Pittsburgh, PA (Hybrid) Classification: Exempt Status: Full-Time Reports To: Director, Quality Purpose The Quality Manager, New Programs, is a key member of the Quality team supporting the design, implementation, and oversight of new drug programs in concert with the Implementation, Operations, IT, and Clinical teams. This role ensures that all service agreements, business rules, and accreditation requirements (URAC, ACHC, and NABP) are accurately incorporated into workflows and procedures, while ensuring patient safety and quality of care. The Quality Manager, New Programs, will validate patient information system workflows, identify process gaps, support program launch activities, and conduct post-launch audits to ensure compliance and continuous improvement. Responsibilities Promotes a culture of safety, transparency, and continuous learning in alignment with Just Culture and continuous quality improvement principles. Leverages pharmacy background and working knowledge of accreditation standards to support new programs during the implementation process. Reviews and interprets manufacturer service agreements and business rules to identify quality impacts for the program and ensure alignment with pharmacy operations and accreditation requirements. Collaborates with cross-functional teams (implementation, operations, clinical, IT, and training) to validate workflows in the patient information system and to ensure seamless integration of quality practices. Tests patient system workflows for new drug program launches, ensuring accuracy, efficiency, and compliance. Identifies and escalates process gaps or risks that may negatively impact patient care, program performance, or accreditation compliance. Conducts quality audits following program launches to ensure a consistent, high-quality patient experience and compliance with service agreements, operational standards, and internal SOPs. Leads and supervises one or more Quality Specialists in auditing programs after launch. Documents findings, trends, and corrective actions, and provides recommendations for process improvement. Attends external implementation meetings to understand patient journey developments and manufacturer expectations Shares findings from internal and external audits, assesses impact, and provides recommendations for changes. Collaborates with leadership to align quality initiatives with business objectives and patient safety priorities. Serves as the subject matter expert for URAC, ACHC, and NABP accreditation standards. Supports internal audits and on-site or virtual accreditation surveys. Other duties as assigned. Required Qualifications: Bachelor's degree in pharmacy, nursing, or a related field; or equivalent experience. Minimum of three (3) years of experience in specialty pharmacy, quality, accreditation, or program implementation. Strong analytical and problem-solving skills with attention to detail. Ability to interpret service agreements, contracts, and accreditation requirements. Proficiency in patient information systems, workflow validation, and process auditing. Excellent written and verbal communication skills. Ability to work collaboratively across departments and with external stakeholders. High degree of self-direction and ability to work independently with little or no supervision. Working knowledge of quality improvement and performance management concepts. Demonstrated ability to lead projects of at least moderate complexity. Ability to manage multiple projects simultaneously, adjusting priorities as needed to meet project deadlines. Preferred Qualifications: Previous experience in a quality role. Experience with process design. Experience with program launches in specialty pharmacy or pharmaceutical manufacturer partnerships. Prior experience supporting accreditation surveys and audits. CPHQ (Certified Professional in Healthcare Quality). Work Environment: This job works in a professional office and home office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and fax machines. Physical Demands: While performing the duties of this job, the employee is regularly required to sit, talk or hear. The employee frequently is required to stand; walk; use hands and fingers to handle or feel; and reach with hands and arms. Visual acuity is necessary for tasks such as reading or working with various forms of data. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential function of the job.

Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals. At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in the Lincoln community. We are a clean, modern site that continues to innovate and grow. Benefits Include: 4 weeks accrued paid vacation and 13 paid holidays. 401(k) match with company profit sharing. Tuition reimbursement and Student Loan repayment program. Great Health, personal, and family benefits starting day 1. Position Summary The Materials Release QA Manager is responsible for QA oversight of incoming inspection, warehousing and shipping, sampling and release of raw materials, packaging and labeling components, and contracted intermediates/finished goods. This position is responsible for the direct supervision of the teams performing these functions. As needed, the Materials Release QA Manager will interface directly with customer and internal auditors, regulatory inspectors and provide guidance and support in the interpretation and enforcement of regulatory guidelines. Hours: 1st shift. Position Responsibilities Oversee and manage the incoming inspection and raw material release teams. Ensure the accurate and efficient preparation of all release documents (raw material, certificates/declarations, etc.). Ensure all materials are compliant with the registered specifications and that releases occur in timely manner. Support the quality of materials and products in a GMP environment. Create and revise material specifications. Ensure the appropriate specifications are in-place. Monitor and identify regulatory/compendial changes affecting raw material requirements. Support Periodic Product Reviews (PPRs) for Raw Materials and Packaging Components Identify and communicate metrics (e.g., release timelines); track RFT on incoming shipments. Identify and escalate areas of risk, particularly those with vendors and materials. Identify and drive to resolution areas of risk associated with vendors and materials. Support the qualification of new vendors/materials. QA oversight of the in-coming materials and outgoing finished goods warehouses. Support site project initiatives. Lead/participate in investigations and change management activities. Support regulatory agency, customer, and internal audits. Support market action activities. Maintain the department Standard Operating Procedures and compliance with the Zoetis Quality standards. Other responsibilities, as assigned. Education and Experience B.A. or B.S. in Sciences or related field and at least 10 years of relevant experience. Technical Skills and Competencies Required Experience with label printing and/or plastic molding (preferred). Leadership and/or supervisory (preferred) experience. Knowledge of USDA, FDA, and EU regulations, with an emphasis on FDA regulations and requirements. Experience in change management processes, regulatory compliance, quality operations, manufacturing for vaccines and/or bio/pharmaceutical manufacturing operations. Demonstrated investigation, problem solving and risk assessment/management skills. Organizational skills, attention to detail. Excellent verbal and written communication skills . Works effectively in a team-based environment. Demonstrated ability to work with internal and external colleagues. Demonstrated knowledge of the Deviation (ETS), Change Control (ETS), Veeva Vault, ERP (SAP) and Laboratory Information Management (LIMS) systems. Physical Position Requirements Ability to sit, stand and walk. Some travel may be required. Occasional overtime/weekend work Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Zoetis Reference Laboratories Quality Manager, East Region Hybrid - Onsite in Louisville and potential for remote days The ZRL Quality Manager will carry out the important role of overseeing the Quality Management System for the East Region, including spoke labs and the Louisville location (ZRL's largest hub laboratory). Responsibilities will include training staff on the QMS and topics related to quality, non-conforming event (NCE) management, internal auditing, document control, policy/SOP writing, quality metric compilation/reporting, liaising with key leaders in other parts of the organization (e.g., medical, customer service, operations) and other quality related duties as assigned. The non-conforming event management duties will include triaging and tracking reported non-conforming events and working with all levels of ZRL staff to ensure timely, appropriate and effective investigation and implementation of corrective/preventive actions (CAPAs). The Quality Manager will carry out investigations and formulate/implement CAPAs for non-technical issues as assigned and work with technical staff to ensure appropriate issue resolution. Job Duties: Triaging, tracking and resolving reported non-conforming events Training staff on Quality Management System and topics related to quality Compilation and reporting of quality metrics Internal auditing, on location in Louisville and traveling to other ZRL labs Writing policies/SOPs and Document Control Duties Other duties as assigned Education/Experience: Bachelor's degree in a natural science (biology, vet science, chemistry, biochemistry, etc) is required. At least three (3) years' experience in Quality Assurance related role required. At least one (1) year on the bench in a veterinary or clinical laboratory required. Experience in Non-conforming Event Management (investigations, root cause analysis and CAPAs), SOP/policy writing, quality metric development/reporting and internal auditing preferred. Training in systems thinking and/or Just Culture preferred. Certification as MLS/MT/MLS/CLS, ISO auditor and/or ASQ preferred. Technical Skills Required: Proficient in Microsoft Office and internet required. Relationship building and cross functional collaboration Effective oral and written communication Indirect leadership and ability to influence change Preferred skills: Experience configuring and using compliance software (MediaLab is utilized) Excel, Power BI and/or other similar software to perform statistical analyses and produce metric reports and dashboards Internal auditing and delivering summary reports Physical Position Requirements: Ability to sit/stand/walk for long periods of time Occasional domestic travel required Full time RegularColleague Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

Summary/objective The Engineering and Facilities (E&F) Planning Coordinator works closely with project team members, members of the leadership team and key customers to help deliver major organizational projects and key initiatives efficiently. The E&F Planning Coordinator manages the technical and administrative tasks, such as scheduling, resource forecasting and planning, document and information distribution, report collation and communication support. The E&F Planning Coordinator, Engineering/Facilities provides direct support to the Facilities and Engineering Team. This position is integral to the successful coordination, alignment, and management between the departments/disciplines related to engineering, design, fabrication, building operations (facilities), EH&S, radiation safety and cGMP quality regulations. You are an open minded, committed team player who is able to meet people where they are and utilize communication and tools to masterfully guide them to the goal. Words used to describe you include self-starter, resilient, exhibits patience and grace. You are energized by completing tasks well and on time, enabling teams to reach optimal outcomes. You are someone who lives and breathes keeping things organized and supporting others in being successful. Essential functions Work independently and with members primarily in or related to the engineering/facilities, accelerator, EH&S, radiation safety including but not limited to project leads within the technical teams, and members in the leadership team.. Maintain portfolio of medium complexity projects supporting manufacturing and continuous improvement. Development of templates and standards for electronic project tracking and resource estimation. Masterfully manage up, down, and across the organization to optimize outcomes and proactively contribute to a fun, nurturing, motivating culture. Provide information and regular support to stakeholders. Serve as point of contact for various working groups; Share relevant documentation and reports with project teams. Develop in-depth understanding of project scope and particulars i.e. timeframes, project teams, etc. Schedule project activities for internal team and contractors. Maintain senior leadership and execution level schedules for project success. Understand formal escalation and review processes. Provide support to project managers and business leaders. Thorough project documentation; Creating and reviewing of reports. Positively influence a diverse team of skilled professionals. Within the department and across the organization, foster a culture of respect, safety, quality, and continuous improvement aligning with the mission, vision, and values of the organization. Competencies Excellent communication and interpersonal skills - you know how to develop & maintain strong relationships with all levels/teams of the organization. Models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal. Understand how to integrate into a new team/organization - appreciate the history of current state, know how and when to make suggestions, as well as using just the right pace to reach the improved future state. Understand your own communication and learning styles, assess others' styles, and are able to find the right path to connect the two. Exceptional technology skills - you find working with any software very comfortable and you easily adapt to new products; Highly efficient with MS Office products; Expert skill with project tracking such as MS Project and Smartsheet is essential. Extremely attentive to details, particularly with written communications, and PowerPoint presentations. Highly responsive and resourceful. Ability to anticipate needs and use good business judgment in escalating priority issues. Extremely confidential; experienced in handling highly sensitive information discreetly. Accountable, responsible, and able to work independently. Very flexible, able to pivot quickly as priorities change. Professional demeanor; calm, polite, kind, well-spoken. Required education and experience Bachelor's degree in engineering, business, management, or related field or equivalent combination of work experience, certifications and/or degree. 8+ years' experience supporting project teams and providing technical and administrative support to others. Preferred education and experience Formal training/experience in agile project management. Formal training/experience with Scrum and Lean project management framework and tools. Project management certification such as CAPM, PMP, PMI-ACP, or CSM. MS Office certification. Educational or work experience with manufacturing, engineering, information systems. Work Environment This job operates in a professional office environment. This role routinely uses standard office equipment. Physical 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. While performing the duties of this job, the employee is occasionally required to: Stand; walk; sit; stand and sit for prolonged periods Use hands and fingers to handle, or feel objects, tools or controls Vision abilities including near vision/acuity and visual color discrimination Talk and hear Reach with hands and arms Climb stairs Wear safety glasses, goggles, gloves, and Tyvek suit Ability to lift or move products and supplies, up to 25 pounds. Position Type/Expected Hours of Work/Travel Full-time position. Company's standard operating hours are Monday thru Friday 6a - 6p with production related activities requiring 24/7/365 shifts. This position is a part of shift work including nights, weekends, and holidays. Niowave has multiple locations within the Lansing area. Travel between locations is expected in the role. .Other duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionDescription: At Cosmos Corporation, we make health and wellness products that help people and pets live better lives. From our O'Fallon, Missouri headquarters, we manufacture high-quality, natural liquid products with ingredients people trust. We are looking for a new ideal team player as a Quality Assurance Manager in our Quality department! The Quality Assurance Manager is responsible for maintaining Cosmos's Quality Management System and maintaining customer expectations across internal teams and external stakeholders. You will be leading and coaching a small department while managing the document control system, supporting the implementation of new products, renewing certifications, issue resolution, improving quality standards, communicating with suppliers, and other responsibilities. Develop and maintain programs related to providing safe, high-quality products. Develop and facilitate Good Manufacturing Practices (cGMP) training for managers and employees. Maintain and manage current ISO 9001:2015 standards. Familiarity with FDA Regulations, including 21 CFR 211. Maintain and continuously improve the Quality Management System. Address and resolve nonconformities and complaints, identify trends, and compliance information to managers and supervisors. Continuous review, update, and train on standard operation procedures (SOPs) and work instructions (WIs). Ownership and maintenance of Cosmos's Hazard Analysis and Critical Control Point (HACCP) Plan. Lead and perform internal and external audits and report findings to internal stakeholders at a regular cadence and provide recommendations for adjustments based on findings. Responsible for upholding customer, consumer, regulatory agency, and certification body expectations related to Cosmos' business processes and products. Provide timely insight and input through involvement with the new product development and product line extensions. Maintains the Document Control Program, including files and tracking databases. Ownership and management of Cosmos's Supplier Quality Program by tracking supplier data, performing supplier audits, collaborating with the Supply Chain Team, and participating in Vendor Reviews. Provide leadership, coaching, and support for direct reports. Lead, support, and respond to customer, regulatory, and third-party audits of the Cosmos Manufacturing Facility. Requirements: You will hold a Bachelor's Degree in food science or a related field. Preventive Controls Qualified Individual (PCQI) Certification is preferred. Five plus years of experience in the field of quality assurance, quality regulations, and implementation and experience in leading a team. Competencies Technical Capacity. Organizational Skills. Teamwork Orientation. Communication Proficiency. A Week In The Life Your work schedule will be Monday through Friday starting at 8:00 a.m. to 5:00 p.m. Weekly tasks for your role will be group huddles, leading and participating in project team meetings, oversight of document control, non-conformance processes, cross-department collaboration through several touchpoints, planning and execution of new products on the manufacturing floor, and participating in issue resolution. On Wednesdays, you will head to the lunch room at 11:40 a.m. for the Cosmos Minute, where the entire company meets at 11:45 a.m. to learn about other team members and special company announcements at Cosmos. What's In It for You Comprehensive medical, dental, and vision insurance. 401(k) with company contribution. Paid vacation, sick leave, holidays, and 5 Mission Days. Short- & long-term disability, life insurance, and supplemental coverages. Development programs. A positive, purpose-driven culture where people truly care about one another. Cosmos is a company that supports and invests in its employees. We have a healthy workplace culture guided by a clear vision, mission, promise, and values! Our culture is intentionally fostered daily by how employees live out our values. The result is a place where employees genuinely enjoy coming to work every day! Equal Opportunity Employer Cosmos Corporation is an equal-opportunity employer. We prohibit discrimination and harassment of any kind as outlined by federal, state, or local laws. Cosmos Corporation makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Requirements You will hold a Bachelor's Degree in food science or a related field. Preventive Controls Qualified Individual (PCQI) Certification is preferred. Five plus years of experience in the field of quality assurance, quality regulations, and implementation and experience in leading a team. Competencies Technical Capacity. Organizational Skills. Teamwork Orientation. Communication Proficiency. A Week In The Life Your work schedule will be Monday through Friday starting at 8:00 a.m. to 5:00 p.m. Weekly tasks for your role will be group huddles, leading and participating in project team meetings, oversight of document control, non-conformance processes, cross-department collaboration through several touchpoints, planning and execution of new products on the manufacturing floor, and participating in issue resolution. On Wednesdays, you will head to the lunch room at 11:40 a.m. for the Cosmos Minute, where the entire company meets at 11:45 a.m. to learn about other team members and special company announcements at Cosmos. What's In It for You Comprehensive medical, dental, and vision insurance. 401(k) with company contribution. Paid vacation, sick leave, holidays, and 5 Mission Days. Short- & long-term disability, life insurance, and supplemental coverages. Development programs. A positive, purpose-driven culture where people truly care about one another. Cosmos is a company that supports and invests in its employees. We have a healthy workplace culture guided by a clear vision, mission, promise, and values! Our culture is intentionally fostered daily by how employees live out our values. The result is a place where employees genuinely enjoy coming to work every day! Equal Opportunity Employer Cosmos Corporation is an equal-opportunity employer. We prohibit discrimination and harassment of any kind as outlined by federal, state, or local laws. Cosmos Corporation makes hiring decisions based solely on qualifications, merit, and business needs at the time. Salary Description $75,000-$90,000/year

Join our Quality Operations team and play a key role in ensuring compliance and building strong partnerships with our customers. In this role, you will manage quality-related processes, lead customer meetings, and drive continuous improvement initiatives that support life-changing therapies. What you will get: An agile career and dynamic working culture An inclusive and ethical workplace Competitive compensation programs that recognize high performance Medical, dental, and vision insurance Opportunities for professional growth and development Our full list of global benefits can be found here: ************************************** What you will do: Serve as the primary QA liaison for assigned customers Manage change controls, deviations, investigations, and CAPAs Lead Joint Quality Team meetings and track action items Review and approve quality documents, including agreements and batch records Support customer audits and ensure compliance with data integrity principles Collaborate with internal teams to resolve quality issues Track and present customer metrics and KPIs What we are looking for: Bachelor's degree in a scientific field or equivalent experience 5-10 years in GMP environments and quality assurance Strong understanding of compliance and regulatory requirements Excellent organizational and analytical skills Ability to manage multiple priorities in a dynamic environment Effective communication and relationship-building skills A proactive, detail-oriented mindset with a focus on quality About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences? Apply now.