Quality Assurance Coordinator jobs at Res-Care Premier - 533 jobs

A leading pharmaceutical company in San Diego seeks a Director, Quality Assurance (GCP) to oversee GCP QA systems, ensuring compliance with regulatory requirements. The role demands extensive experience in GCP as well as a strong leadership and auditing background. The ideal candidate will have a track record of developing quality strategies and collaborating across multiple teams. Competitive compensation includes a salary range of $176,000 - $220,000, alongside comprehensive health benefits and additional perks. #J-18808-Ljbffr

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. The Specialist, QA Shop Floor, Cell Therapy will oversee and partner with operational areas, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Shifts Available: 6pm - 6am, rotating scheduling including holidays and weekends, onsite Responsibilities: Provide routine Quality on-the-floor oversight and triage unexpected events with Manufacturing, Quality Labs, and Supply Chain operations. Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and to the group with clarity, brevity, and accuracy. Identify departures from approved procedures and respond to issues independently while escalating complex issues to senior members. Perform and document operational verification within Manufacturing Execution System (MES) per approved procedures. Observe manufacturing operations and identify departures from procedures, cleanroom behaviors and aseptic techniques. Provide quality oversight for pre-planned return to service plans. Perform area walkthroughs to identify quality issues, propose remediations and support implementation plans with area owners. Identify and propose improvements to programs, procedures, and practices. Review manufacturing batch records or QC testing records to ensure compliance with approved procedures. Review and provide feedback on documents such as forms, logbooks, and procedures. Maintain compliance with assigned learning plan. Provide integration support of newer team members. Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge Review and interpret the technical conclusions of a record/investigation and provide constructive feedback. Participate in quality and shift meetings. Build and maintain relationships with core partner functions and seek collaborative solutions. Share data/knowledge within team by acting as a champion for quality-culture. Knowledge and Skills: Must be action-oriented and proficient in decision-making, building relationships, problem-solving, and analytical thinking. Ability to understand, follow, and apply internal policies, procedures, and quality principles. Prior experience with quality processes, including batch record review, material disposition, change control, product complaints, deviations, investigations, and CAPA management. Ability to assess an unfolding situation, diagnose the problem, and propose practical solutions. Detail-oriented and task-focused with the ability to meet deadlines and prioritize assigned work. Ability to work in a fast-paced team environment with changing priorities with limited information and/or time-constraints. Effectively communicate with cross-functional peers and various levels of management through technical writing and verbal skills. Active listening skills to understand diverse working perspectives. Contributes to a positive team environment. Able to independently make decisions based on data and facts, and recognizes when to escalate Seeks opportunities for improvement to quality and operational problems. Ability to work within pharmaceutical cleanroom environments. Experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management. Experience with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or electronic logbooks/forms. Proficient with digital tools like Microsoft Power Automate, Smartsheet, Tableau, etc. Basic Requirements: Bachelor's degree in STEM field. High school diploma or associate's degree with equivalent combination of education and work experience is considered. 2+ years of relevant cGMP experience with 1+ year of manufacturing site experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing. * BMSCART #LI-ONSITE GPS_2025 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Devens - MA - US: $83,540 - $101,228 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Breaking Data is a boutique healthcare marketing agency serving leading pharmaceutical, biotech, and medical device companies. We specialize in scientific storytelling, creative strategy, and high-impact communications that bring complex brand narratives to life across print, digital, and training platforms. Founded by marketers, for marketers, we pride ourselves on delivering thoughtful, intuitive, and beautifully executed work. Our team is full of “A-teamers”: curious, collaborative, detail-driven people who care deeply about the craft and the quality of what we create. We believe co-location fuels creativity, alignment, and culture. While we offer flexibility, this role is intended for someone who can work 3 days onsite in our Cherry Hill, NJ office and 2 days remote. Senior Editorial and Quality Lead (Healthcare Agency)| Boutique Life Sciences Agency Location: US-Cherry Hill, NJ Employment Type: Full-time Benefits: Health Insurance Compensation, 401K program, Paid time off, and company holidays Opportunity Overview Breaking Data seeks a meticulous Senior Editorial and Quality Lead to serve as the central hub for editorial excellence across pharmaceutical and healthcare deliverables. This hands-on role owns quality control from post-writing drafts through design, reviews, and client approvals-focusing on grammar, style mastery, layout accuracy, and workflow efficiency. Ideal for an experienced editor passionate about the craft of editing. About the Role The Senior Editorial and Quality Lead will own editorial quality control as the central hub across all deliverables-from post-medical writing drafts through design layouts, internal strategy reviews, and client approvals. This hands-on role encompasses proofreading, light editing, layout verification, and workflow coordination for slides, print materials, digital assets, training modules, and long-form content, serving pharmaceutical and healthcare clients. Work closely with medical writers, designers, strategists, and account teams to ensure grammar, style, accuracy, and layout integrity meet the highest agency and client standards. Key Responsibilities Editorial Quality Control Proofread and edit copy developed by medical writers for grammar, clarity, consistency, spelling, accuracy, AMA Manual of Style, and client-specific guidelines. Verify references, superscripts, citations, medical terminology, numeric values, units, symbols, and data formatting. Perform light editing or rewrites to address minor issues and maintain project efficiency. Brand & Compliance Consistency Ensure content aligns with each client's editorial style, tone, branding expectations, and regulatory requirements (including PI/ISI placement when applicable). Confirm correct application of references, anchors, superscripts, and citation formatting. Design & Layout Review Review designed documents and slides (PowerPoint, InDesign, PDFs) to confirm clean, consistent formatting and layout. Verify alignment between copy and design elements (tables, charts, visuals, callouts); identify inconsistencies in spacing, bullets, alignment, superscripts, or content order that could alter meaning. Process & Workflow Execution Manage editorial checkpoints and coordinate handoffs across medical writers, designers, internal strategy reviewers, and clients on multiple concurrent projects. Implement QC edits directly; track and ensure all internal, client, and MLR feedback is accurately incorporated with proper version control and file naming. Serve as the final quality assurance step before client delivery. Requirements Minimum 4-5 years of editorial or proofreading experience in a healthcare, pharmaceutical, or medical communications agency setting. Strong knowledge of the AMA Manual of Style and the ability to apply client-specific style guides and branding requirements. Experience reviewing healthcare or scientific content with a high level of accuracy for terminology, data, units, and references. Demonstrated ability to manage multiple projects and deadlines in a fast-paced, detail-oriented environment. Proficiency in Microsoft Office, Adobe Acrobat Pro, and cloud-based document systems (eg, SharePoint/OneDrive). Exceptional attention to detail and a commitment to editorial precision and quality control. Strong communication and collaboration skills for working with medical writers, designers, strategists, and account teams. Education Bachelor's degree in English, Communications, Journalism, or a related field; a life sciences background is a plus but not required for this role. Work environment Our Cherry Hill, NJ office offers a flexible and collaborative environment. We align projects with each team member's core skills, striking a balance between fun and efficiency to achieve our goals and those of our clients. This is a hybrid position, with 3 days onsite and 2 days remote. Application Process To apply, please submit your resume (and, if available, editing samples) directly through this LinkedIn job posting. Candidates selected for the next steps will be asked to complete a brief editing exercise.

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. RayzeBio is seeking a Quality Control Environment Monitoring Supervisor, reporting to the Director- Microbiology Quality Control. The position will provide oversight for the environmental monitoring program supporting the GMP manufacturing operations related to radiopharmaceuticals. This role will be responsible for the day-to-day EM activities including viable/non-viable monitoring. The supervisor will ensure data trending are executed in compliance with regulations, and company quality standards, troubleshooting efforts, ensuring compliance with regulatory and QA system requirements, and maintaining high standards of quality for radioisotopes and radiopharmaceutical product release. The Environment Monitoring Supervisor will collaborate with the Radiation Safety Officer (RSO) to ensure laboratory compliance with the radiation safety program at the Indianapolis site. The position will require the applicant to work with and around ionizing radiation and hazardous chemicals. The position will be located at RayzeBio's manufacturing plant, in Indianapolis, IN. Job Responsibilities Manage EM program Supervise EM technicians /analysts performing viable, non-viable, personnel, settling plates monitoring in ISO- classified and controlled spaces. Schedule routine and non-routine EM activities to support manufacturing operations and facility readiness. Oversee execution of environmental and utility sampling including microbial identification workflows. Ensure laboratory activities follow SOPs, aseptic techniques, gowning procedures and safety requirements. Review and/or approve EM data, escalate excursions. Lead or support investigations for EM -related investigations, including root cause analysis and CAPA development to ensure timely close-out. Ensure EM program documentation such as SOPs, forms, maps are current and audit-ready. Ensure EM trending, monthly/quarterly reports are performed in a timely manner. Approval of SOPs, trend data, investigations, non-conformances, validation protocols, reports, validation/verifications and equipment qualifications. Develop and maintain appropriate documentation, particularly data analysis and team KPI's. Team Management Supervise a team of EM technicians /analysts. Assign tasks and prioritize workload to ensure timely completion of in an "on-time" and "right first time" manner. Foster a positive and collaborative work environment within the lab and with external stakeholders both within the site and outside the site. Coach team members, conduct performance evaluations and support career development. Continuous Improvement Support continuous improvement programs for EM such as new EM technologies and improve data visibility. Identify other opportunities for process improvements and implement changes to increase quality and efficiency within the Quality Control laboratories. Release of isotope, product and other studies Collaborate with Manager and/or Reviewer to ensure all documentation for release is reviewed. Work with Manager and/or Investigation Writer to ensure any discrepancies are resolved in a timely manner. Quality Assurance/Regulatory Compliance Assist in the routine calibration and maintenance of laboratory equipment. Ensure schedule compliance to ensure GMP readiness. Work with Quality Assurance and Management to implement internal audits. Participate in troubleshooting of issues and implement corrective actions to improve quality processes as a result of investigations or internal audits. Work with RSO and QA to ensure compliance with GMP regulations, safety guidelines, and quality standards (FDA, USP, NRC, EP, and other regulatory agencies as needed). Weekend work, early starts, or late ending times may be required. Up to 10% of travel may be required. Education and Experience ·BS in microbiology or related field with 5+ years of direct radiopharmaceutical experience or 5+ years of experience in pharmaceutical field, OR MS in microbiology or related field with 5+ years of experience in pharmaceutical field. ·At least a year of supervisory experience. ·A strong background in microbiology and aseptic manufacturing is required. Preferred Experience: ·Experience in radiopharmaceutical field ·Experience handling radioactive materials Skills: Highly motivated and organized professional with the ability to work independently or in a team environment. Proficient in viable and non-viable monitoring techniques Strong understanding of cleanroom classifications Attention to details and data integrity Experience with software such as Sherpa or LIMs or equivalent data systems Multi-disciplined scientist with GMP experience. Radiochemistry experience preferred. Experience with root cause techniques such as 6 M's, 5 Why's, fishbone, or similar preferred. Very personable with strong communication skills and cross-functional collaboration Ability to multi-task and prioritize work based on multiple workflows. Good organizational skills are required. Work with multiple computer systems, including Microsoft Office. Excellent professional ethics, integrity, and ability to maintain confidential information Physical Demands While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this job include close vision and distance vision. This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials. * Work Environment The noise level in the work environment is usually moderate. #LI-ONSITE If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: Indianapolis - RayzeBio - IN: $107,904 - $130,754 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit ************************************* Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: * Health Coverage: Medical, pharmacy, dental, and vision care. * Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). * Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off * US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) * Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. * Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to **************************. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: ********************************************* Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at ***************************************** Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at ********************. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1597921 : Quality Control Environment Monitoring Supervisor

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **JOB DESCRIPTION:** **Position Title** : QC Sample Coordinator I **Location:** Bedford, New Hampshire **Department:** Quality Control / Incoming materials **Reporting To:** QC Supervisor, Sample Management **Responsible For (Staff):** No This position will have responsibility for supporting activities in the QC Sample Management group, which includes use of material control procedures and specification documents, raw material sampling & inspection, participation in the coordination of testing with internal and external resources, and collection of data and material certificates for review by QA. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** + Ordering, receipt and management of QC Laboratory supplies, including chemicals, reference standards, and consumable materials in accordance with cGMP and procedural requirements + Inspection, review and receipt of incoming samples for testing. Verification of information against specifications, protocols, and other documentation to ensure compliance. + Maintain sample tracking and chain of custody records in accordance with cGMP and procedural requirements + Complete data entry in validated systems and business tools with a high degree of accuracy. + Request, assemble, and distribute QC testing data packets for support of in-process, lot release, raw material, and stability testing + Assist with coordinating external testing + Request and maintain Quality Control logbooks in accordance with cGMP and procedural requirements + Perform inspections on packaging components **QUALIFICATIONS:** **Required:** + 1-3 years relevant business experience + Proficient in MS Office. + Must have strong attention to detail as well as ability to work in a cross-functional team environment + Professional interpersonal skills and the ability to communicate well orally and in writing + Ability to multi-task in a dynamic environment with changing priorities **Preferred:** + Ability to work independently as well as on a team, with limited supervisory oversight + Master Control experience a plus + cGMP experience a plus \#LI-RS1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

The QA Coordinator - Investigations & CAPA supports site Quality Systems by executing and managing deviations, and CAPAs, compliance with FDA 21 CFR 210/211/11 and ICH Q10. This role drives timely, thorough investigations, applies root cause analysis, ensures effective CAPA implementation, Effectiveness and maintains inspection-ready documentation to uphold product quality and data integrity Reporting to: QA Supervisor Location: Plant Hours: Monday - Friday: 8:00am - 4:00pm Responsibilities/Essential Duties: Investigations and CAPA Management Leads or supports investigations for deviations, OOS/OOT events, nonconformances, and complaints to ensure timely, complete, and compliant documentation per 21 CFR 211.192 and ICH Q9/Q10. Performs structured Root Cause Analysis (5-Why, Fishbone, FMEA) to identify true root causes and prevent recurrence. Develops and manages Corrective and Preventive Actions (CAPAs) that are specific, measurable, and linked to verified root causes, ensuring implementation, verification, and documented effectiveness within defined timelines. Analyzes and trends investigation and CAPA data to identify systemic issues, recommends process or procedural improvements, and reports performance metrics to Quality leadership. Ensures all records meet ALCOA+ data-integrity standards and are inspection-ready. Promotes a culture of investigative rigor, continuous improvement, and accountability across Manufacturing, QC, and Engineering functions. Qualifications: Education & Experience Bachelor's degree in Life Sciences, Engineering, or related technical field required. Minimum 1-4 years of Quality Assurance experience in a cGMP-regulated pharmaceutical, OTC, or medical device environment. Demonstrated expertise in managing deviations and CAPAs, Experience with FDA inspections and supporting regulatory audits is highly preferred. Technical Skills In-depth knowledge of 21 CFR Parts 210, 211, 11, ICH Q7-Q10, and relevant USP chapters. Proficiency in root cause analysis tools and Six Sigma methodologies. Experience using electronic Quality Management Systems (eQMS) such as MasterControl, Veeva, or ETQ Reliance. Familiarity with data integrity requirements and ALCOA+ compliance. Key Competencies Investigative Rigor: Executes high-quality, inspection-ready investigations with accurate root cause identification. CAPA Execution: Ensures timely, effective, and risk-based corrective actions. Compliance Stewardship: Upholds data integrity and documentation standards across all QA systems. Collaboration: Works effectively across departments to align investigation outcomes with operational needs. Accountability: Tracks and deliveries on commitments with minimal supervision. Working Conditions: Primarily office-based with routine interaction in manufacturing and laboratory environments. May require off-shift or weekend support during audits, investigations, or operational escalations. Occasional travel may be required for training or supplier quality support Company Summary: Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments. What Revance invests in you: Competitive Compensation including base salary and annual performance bonus Paid time off, holidays, and floating holidays that can be used for whatever you choose Generous healthcare benefits, Employer HSA match, 401k match, wellness discounts and much more This section of the is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.” Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Job DescriptionDIRECT HIRE: A great opportunity for a Quality Assurance Assistant to join a dynamic team in the Allentown, PA. area. Hourly Rate: $19hr - $23hr Benefits: Medical, dental, vision, PTO, 401K, short-term disability, employee life Schedule: M-F, 40hrs +OT Roles & Responsibilities: Test and conduct routine and non-routine in-process inspection of production output, measure samples of finished product and check production quality verifications for completeness, timeliness and tolerances as well as complete product testing of finished goods Assist with incoming inspections for internal / external suppliers as directed Confirm discrete job special instructions are being followed or met Member of daily audit team for various product and process audits per checklist Participant in the revision and update of standard operating procedures Conduct and complete Internal Quality audits and may be involved in the development of testing method Ensure employees adhere to safety and quality standards Skills and qualifications: 1-3 years manufacturing experience: required (metal, paint/finishing industries: a plus) High School Diploma or GED: required ISO 9000 and 5S Program knowledge and experience Measuring tools knowledge and experience Customer focused mindset Proven hands-on shop floor experience; forklift experience Working knowledge Microsoft Office (Word, Excel, PowerPoint) Good work record; Strong work ethic Strong communication and interpersonal skills Good teamwork and time management skills Experience in a high volume fast paced environment Once you apply, please text "QAA" to ************ for a faster reply. INDH Powered by JazzHR OotkEOc0H6

DIRECT HIRE: A great opportunity for a Quality Assurance Assistant to join a dynamic team in the Allentown, PA. area. Hourly Rate: $19hr - $23hr Benefits: Medical, dental, vision, PTO, 401K, short-term disability, employee life Schedule: M-F, 40hrs +OT Roles & Responsibilities: Test and conduct routine and non-routine in-process inspection of production output, measure samples of finished product and check production quality verifications for completeness, timeliness and tolerances as well as complete product testing of finished goods Assist with incoming inspections for internal / external suppliers as directed Confirm discrete job special instructions are being followed or met Member of daily audit team for various product and process audits per checklist Participant in the revision and update of standard operating procedures Conduct and complete Internal Quality audits and may be involved in the development of testing method Ensure employees adhere to safety and quality standards Skills and qualifications: 1-3 years manufacturing experience: required (metal, paint/finishing industries: a plus) High School Diploma or GED: required ISO 9000 and 5S Program knowledge and experience Measuring tools knowledge and experience Customer focused mindset Proven hands-on shop floor experience; forklift experience Working knowledge Microsoft Office (Word, Excel, PowerPoint) Good work record; Strong work ethic Strong communication and interpersonal skills Good teamwork and time management skills Experience in a high volume fast paced environment Once you apply, please text "QAA" to ************ for a faster reply. INDH

Turning Point Community Programs is seeking a Quality Assurance Coordinator for our Transition Support Services (TSS) North program in Chico. Turning Point Community Programs (TPCP) provides integrated, cost-effective mental health services, employment and housing for adults, children and their families that promote recovery, independence and self-sufficiency. We are committed to innovative and high quality services that assist adults and children with psychiatric, emotional and/or developmental disabilities in achieving their goals. Turning Point Community Programs (TPCP) has offered a path to mental health and recovery since 1976. We help people in our community every single day - creating a better space for all types of people in need. Join our mission of offering hope, respect and support to our clients on their journey to mental health and wellness. GENERAL PURPOSE Under the administrative supervision of the Clinical Director, this position is responsible for ensuring that the program remains in compliance with Regional Center guidelines. Assists the Clinical Director in the quality management functioning of the Program. DISTINGUISHING CHARACTERISTICS This is an at-will administrative position within a program. Additionally, this position is responsible for the day-to-day completion of critical paperwork and assisting the Clinical Director. ESSENTIAL DUTIES AND RESPONSIBILITIES - (ILLUSTRATIVE ONLY) The duties listed below are intended only as illustrations of the various types of work that could be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related or a logical assignment to this class Completes Diagnosis updates as assigned. Completes MORS/8 Determinants assessments as assigned. Tracks progress notes and provides feedback directly to management team. Tracks assessments due and completion. Works in coordination with the Team Leaders and Clinical Director to ensure that all assessments and client plans are completed in a timely manner. Attends/Conducts Utilization Review meetings when the Clinical Director is not available. Coordinates with Clinical Director to implement recommendations. Responsible for tracking and reviewing results of internal utilization and review. Reviews charts to ensure that they meet state and legal/Regional Center requirements. Assists the Clinical Director and Program Director with developing the Quality Improvement plan and implementing changes. Assist the Clinical Director with filing, organizing and maintaining a record of KETs (Key Event Tracking) and inputting data into charted system. Assist the Clinical Director with filing, organizing and maintaining a record of Risk Management Binder (SIRs). In coordination with the Clinical Director and Program Director, reviews and evaluates customer satisfaction/performance outcome data. Ensures the safety, health, and well-being of the members. Completes paperwork as assigned in a timely manner. Meets the standards set for performance in all aspects of job duties. Provides support to other staff members as needed. Adheres to and upholds the policies and procedures of Turning Point Community Programs. Attends staff meetings unless approval for non-attendance is secured from the Clinical Director or Program Director. Schedule: Monday - Friday, 8:30 am - 5:00 pm Compensation: $26.00 - $27.59 per hour Interested? Join us at our open interviews on Wednesdays from 2-4PM, located at 10850 Gold Center Drive, Suite 325, Rancho Cordova, CA 95670 -or- CLICK HERE TO APPLY NOW!

Nature and Scope The QA Specialist - Deviations will be responsible for effectively ensuring non-routine events are investigated and documented in accordance with company SOPs, policies and cGMPs. This is a cross-functional position that interacts with all departments at American Regent. Ensures quality system compliance with GMPs, procedures and documentation within the company and in keeping with regulatory requirements and company procedures. The role is responsible for authoring, reviewing, and providing the final Quality approval for investigations into manufacturing and laboratory events/deviations. The role interacts with all levels of the organization and is expected to use professional judgment in appropriate issue escalation to management. 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. Ensures any non-routine events associated with the manufacture of safe, pure, and effective sterile pharmaceuticals are investigated and documented in accordance with company SOPs, policies and cGMPs and within assigned timelines. Identify trends, evaluate metrics, and provide support for internal audits under the direction of the QA Deviations Supervisor. Ensure deviation timelines are maintained through inter-department communication. Facilitate and lead assigned investigations involving multiple investigation areas. Facilitate and participate in initiatives to address compliance gaps identified during investigations with minimal assistance. Provide quality system level assessments and reviews, author and facilitate change requests. Initiate and complete or assign investigations and CAPAs related to Quality departments (Quality Operations, Quality Control, Quality Systems). Perform and guide root-cause analysis for events utilizing investigation tools (e.g., 5 whys, 6M, Fishbone Diagrams). Perform the QA review and final approval signature for assigned deviations/events, confirming the completeness, accuracy, and consistency of all work so that it meets the standards of quality. Identify errors and inconsistencies and initiate resolution to ensure high quality. Coordinate/provide oversight for the investigations system, including follow up with cross-functional stakeholders (assignees, internal customers, reviewers, and approvers). Act as a liaison between Operations and Quality in all matters related to investigations and CAPA. Under supervision assist with documentation for the closure of complaint investigations. Gather data for reports, metrics, Annual Product reviews and external requests. Generate and analyze metrics as assigned, employing statistical techniques as appropriate. Scheduling departmental meetings, maintaining meeting minutes and attendance. Maintain departmental records and files (both electronic and manual). Participate in cross-functional project teams as required. Support, coordinate, and assist with regulatory agency audits and inspections as required. Support and maintain quality programs, policies, processes, procedures, and controls ensuring compliance with current Good Manufacturing Practices (cGMP). Keep training curriculum current in ISO train. Ensure all work is performed and documented in accordance with existing company policies and procedures. 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. Bachelor's degree in a science or engineering field. ASQ Certification as a Quality Engineer or Six Sigma Black belt preferred. Minimum of 2-5 years of experience working in a Quality role within a cGMP manufacturing environment required. Knowledge and understanding of quality assurance principles, controls, and interactions between Quality Systems; FDA guidance, ICH, PIC/S, etc. Strong attention to detail, adherence to SOPs. Ability to work effectively in a collaborative environment. Ability to effectively work under dynamic constraints, with success in managing multiple activities concurrently and producing outstanding results. Strong organizational, interpersonal and communication skills (oral and written). Written skills must be audit-level appropriate for non-routine or complex issues. Ability to apply critical thinking to scientific problems and demonstrated knowledge. Ability to apply statistical quality management concepts. PC Skills Required (MS Word, Excel). Preference will be given to candidates with demonstrated knowledge of Quality software such as TrackWise, Veeva and Minitab. Excellent English communication skills, both oral and written, and comprehension are required. Ability to effectively present information to top management, employees, or customers. Physical Environment and Requirements Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees. Expected Salary range: $79,900-$85,000 The salary range displayed is the minimum and maximum salary range for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience. American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits. 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 **************************************.

DIRECT HIRE: A great opportunity for a Quality Assurance Assistant to join a dynamic team in the Allentown, PA. area. Hourly Rate: $19hr - $23hr Benefits: Medical, dental, vision, PTO, 401K, short-term disability, employee life Schedule: M-F, 40hrs +OT Roles & Responsibilities: Test and conduct routine and non-routine in-process inspection of production output, measure samples of finished product and check production quality verifications for completeness, timeliness and tolerances as well as complete product testing of finished goods Assist with incoming inspections for internal / external suppliers as directed Confirm discrete job special instructions are being followed or met Member of daily audit team for various product and process audits per checklist Participant in the revision and update of standard operating procedures Conduct and complete Internal Quality audits and may be involved in the development of testing method Ensure employees adhere to safety and quality standards Skills and qualifications: 1-3 years manufacturing experience: required (metal, paint/finishing industries: a plus) High School Diploma or GED: required ISO 9000 and 5S Program knowledge and experience Measuring tools knowledge and experience Customer focused mindset Proven hands-on shop floor experience; forklift experience Working knowledge Microsoft Office (Word, Excel, PowerPoint) Good work record; Strong work ethic Strong communication and interpersonal skills Good teamwork and time management skills Experience in a high volume fast paced environment Once you apply, please text "QAA" to ************ for a faster reply. INDH

Sanford, NC, USA Full-time ** Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. **Job Description** **POSITION RESPONSIBILITIES:** + Coordinate and perform workflow for laboratory operations support of multiple cGMP laboratories. + Timely and accurate cGMP compliant processing of incoming and outgoing samples and reference materials. + Accession samples into LIMS Sample Management and initiates sample chain-of-custody. + Successfully complete all responsibilities for on-time availability of samples and reference standard material in accordance with Sample Management SOPs and other associated SOPs. + Assist with the implementation of process improvement initiatives. + Ensure data integrity and traceability. + Generate and maintains records in a regulatory compliant manner. + Contribute to oversight of Sample Management laboratory. + Ability to independently follow standard protocols, performs associated tasks without errors per applicable SOPs. + Assist in distribution of all samples destined for various QC laboratories. + Perform sample aliquoting in a Biosafety cabinet using aseptic techniques as needed. + Support inventory control of all retain, reference and reserve samples, including stability samples. + Support for timely and effective investigation of area deviations or corrective actions. + Interact with other functional areas and/or vendors to resolve problems, enhance processes and service delivery. + Work through Protocol questions, issues, escalations and changes with relevant project team members. + Coordinate information and communications for designated projects at the site level, including identification and escalation of discrepancies as needed. + Operate effectively in both a team and individual setting. + Provide excellent written and oral communication skills. + Initiate and manage day-to-day tasks effectively. + Utilize excellent organizational skills and attention to detail. + Maintain laboratory 5S organization, perform additional duties as needed **Qualifications** **BASIC MINIMUM QUALIFICATIONS:** + Bachelor's degree in Scientific discipline or associate's degree and 0-1 years of industry experience or equivalent. + Ability to utilize email, word processing and spreadsheet software. + Ability to compute basic arithmetic operations: addition, subtraction, multiplication, and division. + Authorization for employment in the United States. **PREFERRED QUALIFICATIONS:** + Moderate understanding of ICH Guidelines as they pertain to Stability Studies and programs. + Knowledge of GMPs, safety regulations and data integrity preferred. + Proven fundamental use of LIMS systems + Knowledge of material receipt and inventory control. **Additional Information** Position is **Full Time, Wednesday-Sunday, 3pm-11:30pm** with overtime as needed **. Flexibility to train M-F 8am-5pm may be needed.** Candidates currently living within a commutable distance of **Sanford, NC** are encouraged to apply. Excellent full time benefits including comprehensive medical coverage, dental, and vision options. + Life and disability insurance + 401(k) with company match + Paid vacation and holidays **Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.**

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description POSITION RESPONSIBILITIES: * Coordinate and perform workflow for laboratory operations support of multiple cGMP laboratories. * Timely and accurate cGMP compliant processing of incoming and outgoing samples and reference materials. * Accession samples into LIMS Sample Management and initiates sample chain-of-custody. * Successfully complete all responsibilities for on-time availability of samples and reference standard material in accordance with Sample Management SOPs and other associated SOPs. * Assist with the implementation of process improvement initiatives. * Ensure data integrity and traceability. * Generate and maintains records in a regulatory compliant manner. * Contribute to oversight of Sample Management laboratory. * Ability to independently follow standard protocols, performs associated tasks without errors per applicable SOPs. * Assist in distribution of all samples destined for various QC laboratories. * Perform sample aliquoting in a Biosafety cabinet using aseptic techniques as needed. * Support inventory control of all retain, reference and reserve samples, including stability samples. * Support for timely and effective investigation of area deviations or corrective actions. * Interact with other functional areas and/or vendors to resolve problems, enhance processes and service delivery. * Work through Protocol questions, issues, escalations and changes with relevant project team members. * Coordinate information and communications for designated projects at the site level, including identification and escalation of discrepancies as needed. * Operate effectively in both a team and individual setting. * Provide excellent written and oral communication skills. * Initiate and manage day-to-day tasks effectively. * Utilize excellent organizational skills and attention to detail. * Maintain laboratory 5S organization, perform additional duties as needed Qualifications BASIC MINIMUM QUALIFICATIONS: * Bachelor's degree in Scientific discipline or associate's degree and 0-1 years of industry experience or equivalent. * Ability to utilize email, word processing and spreadsheet software. * Ability to compute basic arithmetic operations: addition, subtraction, multiplication, and division. * Authorization for employment in the United States. PREFERRED QUALIFICATIONS: * Moderate understanding of ICH Guidelines as they pertain to Stability Studies and programs. * Knowledge of GMPs, safety regulations and data integrity preferred. * Proven fundamental use of LIMS systems * Knowledge of material receipt and inventory control. Additional Information Position is Full Time, Wednesday-Sunday, 3pm-11:30pm with overtime as needed. Flexibility to train M-F 8am-5pm may be needed. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply. Excellent full time benefits including comprehensive medical coverage, dental, and vision options. * Life and disability insurance * 401(k) with company match * Paid vacation and holidays Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. May participate in investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Job Description Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc. Typically supports one Par business, at a single site Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time Accountability Responsibilities % of Time Analysis & Testing * Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. * Uses laboratory software for analyses 65% Lab Equipment * Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping * Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals * Under close supervision, learns to troubleshoot basic instrument problems 20% Investigations * With guidance, participates in OOS/OOT/NOE and other investigations * Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor * May assist in drafting, editing, and reviewing SOPs and laboratory investigations 10% Training * Maintains assigned training records current and in-compliance * May assist in the training of less senior laboratory staff 5% Compliance * Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting * Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs * Follows internal processes related to controlled substances continuous Safety * Follows EH&S procedures to ensure a safe work environment * Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous Total 100% Qualifications Education & Experience Minimal acceptable level of education, work experience and certifications required for the job * Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. * Some pharmaceutical laboratory experience preferred. Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. * Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. * Basic knowledge of wet chemistry techniques * Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS * Competency in Microsoft Office Suite Skills & Abilities Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc. * Ability to display and analyze data in a logical manner * Good verbal and written communication skills as well as good computer skills * Attention to details and accurate record keeping * Establish and maintain cooperative working relationships with others * Solid organizational skills * Ability to take initiative, set priorities and follow through on assignments Physical Requirements Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. * Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals * Must occasionally lift and/or move up to 15-25 lbs. * Ability to wear personal protective equipment, including respirators, gloves, etc. * Specific visions abilities are required by this job include close vision and color vision * Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview The Quality Assurance Data Coordinator will be responsible for supporting the QA department in respect to batch record preparation and labels. The QA Data coordinator will also be responsible for maintaining records and filing. This position reports to the QA Manager. Responsibilities Accountabilities and Responsibilities: Issue requested batch records for next day's production and attach necessary stamped labels Label coordination/management-design, etc. Order labels for Production, check in labels, maintenance of label storage according to cGMP regulations. Issue and track training records for all records, including batch records, SOPs and other miscellaneous required training Maintain MSDS Sheets WFI auditing and document maintenance Filing of SOPs, Product specs, RM specs and other miscellaneous filing as needed Log book updates and auditing Maintain work center logs and equipment logs in an orderly manner Track supplements and ensure proper closure and follow up Back up Admin Assistant as needed on batch record entry and other miscellaneous operations assignments File completed batch records and other filing as necessary. Maintain tight control of batch record fils Qualifications/Skills 3 or more years of office experience Strong computer skills Manufacturing office background preferred Education, Experience & Licensing Requirements High school diploma Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. #LI-RD1High school diploma Accountabilities and Responsibilities: Issue requested batch records for next day's production and attach necessary stamped labels Label coordination/management-design, etc. Order labels for Production, check in labels, maintenance of label storage according to cGMP regulations. Issue and track training records for all records, including batch records, SOPs and other miscellaneous required training Maintain MSDS Sheets WFI auditing and document maintenance Filing of SOPs, Product specs, RM specs and other miscellaneous filing as needed Log book updates and auditing Maintain work center logs and equipment logs in an orderly manner Track supplements and ensure proper closure and follow up Back up Admin Assistant as needed on batch record entry and other miscellaneous operations assignments File completed batch records and other filing as necessary. Maintain tight control of batch record fils

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about. Job Summary The Quality Control (QC) Coordinator is a key administrative and logistical support role within the Quality Control department, ensuring the efficient and compliant management of all product samples and associated data. This position serves as the central point of coordination for sample lifecycle activities, from receipt and inventory management to data archiving and external shipment, while strictly adhering to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). The coordinator works cross-functionally with Project Managers (PMs), laboratory personnel, and external testing sites to maintain data integrity and operational efficiency. Key Responsibilities and Duties: * Coordinate the receipt, logging, labeling, storage, tracking, and disposal of all QC samples. * Maintain accurate inventory records of all retain, stability, and release samples using LIMS or designated tracking systems. * Prepare documentation (sample submission forms, shipping request forms, etc.) and coordinate compliant shipment of samples to clients and external testing sites. * Manage the process for pulling stability samples at specified time points for testing initiation. * Systematically retrieve, archive, and track QC data packages, ensuring secure storage and accessibility. * Collaborate with departments to perform audit trail reviews on electronic instrument reports and raw data to ensure data integrity and 21 CFR Part 11 compliance. * Maintain and update trackers, logbooks, and databases reflecting current sample and testing statuses. * Serve as the liaison for sample data requests, collaborating with Project Managers and other stakeholders. * Provide administrative and logistical support to the Quality Control department and management team for ad-hoc projects and general coordination tasks as required. Job Qualifications * High school diploma or equivalent is required. An Associate or Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Life Sciences) or relevant higher education is strongly preferred. * 1-3 years' experience in a GMP/GLP environment (QC or sample management preferred) * Proficiency in LIMS, EDMS, and MS Office Suite (Excel, Word) preferred * Exceptional attention to detail and strong organizational skills. * Excellent communication skills for effective internal and external collaboration. * Ability to manage multiple priorities in a fast-paced environment. Compensation Data The pay rate for this role is $24.00 - $26.00 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location. About Charles River's CDMO Services With over 20 years of experience and industry-leading expertise, Charles River's cell and gene therapy Contract Development and Manufacturing Organization (CDMO) group supports biotechnology and pharmaceutical companies in advancing their complex programs from early development through commercialization. Our integrated, phase-appropriate CDMO capabilities-including plasmid DNA, viral vector, and cell therapy manufacturing-enable seamless development and faster timelines. With centers of excellence in the US and UK, we offer GMP-compliant and research-grade solutions, along with comprehensive analytical services and regulatory support. Whether clients need end-to-end development, standalone services, or insourced support, our CDMO team provides custom solutions to meet evolving program needs. From process development in Hanover to viral vector manufacturing in Rockville, large-scale cell therapy production in Memphis, and plasmid DNA services in Keele, we simplify the supply chain and accelerate cell and gene therapy breakthroughs. About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility. Equal Employment Opportunity Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws. It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_**********. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit *************** 231565

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. This position will have responsibility for supporting activities in the QC Sample Management group, which includes use of material control procedures and specification documents, raw material sampling & inspection, participation in the coordination of testing with internal and external resources, and collection of data and material certificates for review by QA. **Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. + Review all incoming material receipt packets to assess testing needs + Schedule and perform sampling of raw materials across the PCI Madison, WI Sites + Request quotes and purchase orders for testing performed externally + Assist with regular communications with 3 _rd_ party labs performing external testing + Complete and submit all applicable sample submission paperwork to the appropriate testing labs + Escalate testing failure or safety concerns to management in a timely fashion + Assist in deviation, out-of-specification or aberrant result investigations, as needed + Assist with the writing and revision of cGMP documents and Raw Material Specifications documents to meet industry standards + Assist with reviewing testing results to ensure accuracy and compliance. + Perform routine cleaning of sampling facilities + Routinely perform aseptic sampling inside a Biological Safety Cabinet + Perform dimensional inspections on packaging components + Perform routine data generation and problem solving + Order/restock laboratory and office supplies, as needed. + Complete assigned training in a timely fashion **Special Demands:** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. + Must be able to walk and drive between local sites + Must be able to physically wear laboratory protective attire and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves + Must be comfortable working with and handling hazardous materials in safety cabinets **Work Environment:** The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Laboratory, manufacturing, warehouse **Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. + 0-3 years relevant business experience + Proficient in MS Office. + Must have strong attention to detail as well as ability to work in a cross-functional team environment + Professional interpersonal skills and the ability to communicate well orally and in in writing + Ability to multi-task in a dynamic environment with changing priorities + Ability to work independently as well as on a team, with limited supervisory oversight + Master Control experience a plus + cGMP experience a plus Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **Position Title: Quality Control Coordinator** **Location: Assembly Drive, Rockford, IL 61109** **Shift: 1st Shift** **SUMMARY** The Quality Coordinator assists with coordinating quality activities to ensure that goals and objectives of the team are accomplished within prescribed time frames. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management. **Essential Duties and Responsibilities:** + Prepares and distributes required documentation for requested production work orders. + Perform documentation review of completed orders to ensure compliance with cGMP's and customer requirements. + Reviews and interprets customer standards, procedures, and specifications for dissemination relative to batch records, forms and material specifications. + Prepares customer required samples for shipment according to approved shipping instructions. + Prepares and submits batch records, accountability reports and necessary documentation to customers to facilitate product release. + Organize internal and customer approval of batch records and specs. + Perform record reviews of both completed and in-process orders to ensure compliance with cGMP's and customer requirements. + Perform Line Clearance inspections of equipment and production suites. + Help identify, communicate, track and resolve document related issues with other departments and customers. + Function as one of the customer points for comments or questions pertaining to batch records. + Initiating supplier non-conformance reports and effectuates material control. + Reviews and integrates planned deviation requests into batch records when needed. + Adherence to PCI and cGMP policies, procedures, rules and regulations. + Attendance to work is an essential function of this job. + May perform label creation duties including generating computerized labels. + May perform duties of Quality Auditor as assigned by Supervisor/Manager. + Other duties as assigned by Supervisor/Manager. + Shift is Monday through Friday 8:00 am to 5:00 pm. **Qualifications:** **Required:** + High School Diploma or GED + 1-3 years related experience and/or training. + Basic Mathematical Skills + Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs. + Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. + Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables. + High Standard of Report Writing **Preferred:** + Ability to follow instructions and respond to management direction. + Ability to work independently and/or part of a team. + Ability to display excellent time management skills. + Ability to demonstrate attention to detail. + A college degree with a concentration in a scientific discipline is preferred. + The candidate must be able to demonstrate basic proficiency with computers, business software (e.g. MS Office) and technical software (e.g. Master Control). Ability to create, use and interpret scientific tables, charts, and graphs. Any Lean Six Sigma or process improvement training is a plus. For Illinois residents: the hiring rate for this position is $18.15 to $20.42 hourly plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). _Equal Opportunity_ _Employer/Vet/Disabled_ Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job Overview This role serves as a senior Quality Assurance subject matter expert responsible for final review and approval of analytical and batch records, oversight of SAP quality transactions, and leadership of OOS, deviations, investigations, and CAPA activities in compliance with cGMP requirements. Key responsibilities include leading supplier and internal audits, supporting regulatory inspections and customer interactions, approving analytical and method development documentation, and ensuring data integrity and material release decisions. The position also provides mentorship to QA staff, supports critical quality decisions, and drives continuous improvement to maintain inspection readiness and regulatory compliance. Responsibilities Serve as a subject matter expert for In-Process and Finished Goods Analytical Records (AR) and Batch Records (BR) review and final approval. Provide advanced oversight and approval of SAP quality transactions, including material determination and disposition decisions. Lead and approve Out of Specification (OOS), Deviations, and Investigations utilizing TrackWise, ensuring root cause analysis and CAPA effectiveness. Issue, review, and approve inspection, repackaging, and rework records with minimal oversight. Plan, lead, and report Critical Supplier and Quality Service Provider (QSP) audits, including follow-up on corrective actions. Review and approve Raw Material Analytical Records and oversee material release decisions. Oversee Laboratory and Operations notebook issuance, ensuring compliance with data integrity and cGMP requirements. Act as a primary QA contact for customers, internal stakeholders, and regulatory inspections. Review and approve Method Validation, Analytical Development, and Method Development reports, providing compliance and technical guidance. Design, implement, and maintain cGMP training programs, including training materials, assessments, and effectiveness monitoring. Lead or co-lead internal cGMP audits, including risk assessments, audit planning, execution, reporting, and CAPA tracking. Provide mentorship, guidance, and technical support to QA Auditors and Inspectors. Serve as a senior after-hours QA resource on a rotational basis for critical quality decisions. Act as backup or escalation support for Raw Material inspections, sampling activities, and WFI water sampling when required. Support continuous improvement initiatives related to quality systems, audit readiness, and regulatory compliance. All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned. Qualifications/Skills Demonstrated expertise in cGMP regulations, including 21 CFR Parts 210/211, ICH Q7, and regulatory inspection readiness. Proven experience leading audits, investigations, and complex quality decisions with minimal supervision. Strong oral and written communication skills, including interaction with customers and regulatory agencies. Proficient in Windows-based systems, including word processing, spreadsheets, databases, and electronic quality systems (e. g. , TrackWise, SAP). Ability to mentor junior staff, manage multiple priorities, and exercise sound judgment in high-impact quality decisions. Education, Experience & Licensing Requirements Bachelor's degree in Chemistry or a related scientific discipline, or equivalent industry experience. Advanced coursework in Chemistry, Mathematics, or computer systems is beneficial. 5-8+ years of progressive Quality Assurance experience in a regulated manufacturing environment, preferably pharmaceutical or CDMO. Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. Bachelor's degree in Chemistry or a related scientific discipline, or equivalent industry experience. Advanced coursework in Chemistry, Mathematics, or computer systems is beneficial. 5-8+ years of progressive Quality Assurance experience in a regulated manufacturing environment, preferably pharmaceutical or CDMO. Serve as a subject matter expert for In-Process and Finished Goods Analytical Records (AR) and Batch Records (BR) review and final approval. Provide advanced oversight and approval of SAP quality transactions, including material determination and disposition decisions. Lead and approve Out of Specification (OOS), Deviations, and Investigations utilizing TrackWise, ensuring root cause analysis and CAPA effectiveness. Issue, review, and approve inspection, repackaging, and rework records with minimal oversight. Plan, lead, and report Critical Supplier and Quality Service Provider (QSP) audits, including follow-up on corrective actions. Review and approve Raw Material Analytical Records and oversee material release decisions. Oversee Laboratory and Operations notebook issuance, ensuring compliance with data integrity and cGMP requirements. Act as a primary QA contact for customers, internal stakeholders, and regulatory inspections. Review and approve Method Validation, Analytical Development, and Method Development reports, providing compliance and technical guidance. Design, implement, and maintain cGMP training programs, including training materials, assessments, and effectiveness monitoring. Lead or co-lead internal cGMP audits, including risk assessments, audit planning, execution, reporting, and CAPA tracking. Provide mentorship, guidance, and technical support to QA Auditors and Inspectors. Serve as a senior after-hours QA resource on a rotational basis for critical quality decisions. Act as backup or escalation support for Raw Material inspections, sampling activities, and WFI water sampling when required. Support continuous improvement initiatives related to quality systems, audit readiness, and regulatory compliance. All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.