Quality Assurance Specialist jobs at Takeda Pharmaceuticals U.S.A., Inc. - 838 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.

Are you ready to charter your own career? The runway to success in global logistics begins here... Are you looking for an opportunity to work for a global brand where you can use your skills, be part of a diverse team and grow with a dynamic company? We are looking for a Express Airfreight Specialist to join the NFO team in Los Angeles OR Pasadena, California. The successful candidate will be passionate about the logistics industry, target and goal driven and have experience in freight forwarding and/or time-critical cargo. Purpose of the Role To evaluate customer needs and logistics/courier requirements and format an effective plan to meet such needs and requirements. To handle, monitor and follow-up on incoming customer requests for OBC/NFO shipments in a 24/7 shift cover. To maximize business opportunities by offering customers tailored-made solutions to meet with clients' requests within operational restrictions. To build strong productive relationships with clients to ensure business objectives are achieved. Responsibilities of the Role To exercise both discretion and independent judgment in performing the duties of the job. To work with management to develop appropriate policies to achieve the goals of the Company. To work directly with management to implement Company policies to ensure that customer needs are being met, such as budgeting and on time delivery. To evaluate customer business needs and logistics/courier requirements and format an effective plan to meet such needs and requirements. To handle, monitor and follow-up on incoming requests for OBC/NFO shipments in a 24/7 shift cover. To maximize business opportunities by offering customers tailored-made solutions to meet with clients' requests within operational restrictions. To build strong productive relationships with clients to ensure business objectives are achieved. Preparing of time-critical routing options for incoming requests ensuring a timely offer with detailed and accurate information is provided to clients. Allocating of couriers to pending orders for worldwide requests and booking of their travel arrangements. Liaise, direct and give clear detailed instructions and information to couriers on their assignments and modify assignments as broker deems necessary to meet global customer needs. Monitor and tracking of on-going shipments with the purpose to ensure a high quality service is delivered to the customers and the company's expectations are met at any time. Sourcing, selecting and negotiating with external suppliers and service providers with the responsibility of determining and delivering appropriate training if necessary to meet the company requirements. Debtor and Creditor Invoicing and order settlement. Keep up to date with activities of OBC/NFO coordinator(s) using the appropriate network of communication. Qualifications * Freight Forwarding and/or Time Critical Cargo experience is highly preferred. * Ability to travel when required in line with business needs. What We Offer Competitive salary Comprehensive benefits package Opportunity to join a global company and be part of a diverse international team Professional development and career opportunities Unlimited access to thousands of courses on LinkedIn Learning platform With more than 50 years of experience, the Chapman Freeborn group provides a diverse range of aviation-related services on a global basis. Our expertise in all areas of the air charter industry makes us the number one choice for many of the world's leading logistics providers, multinational corporations, travel partners, and well-known names from the entertainment business. Chapman Freeborn is a family member of Avia Solutions Group, a leading global aerospace services group with almost 100 offices and production stations providing aviation services and solutions worldwide. Avia Solutions Group unites a team of more than 11,500 professionals, providing state-of-the-art solutions to the aviation industry and beyond. Chapman Freeborn provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. 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. Download offer as PDF

The Quality Assurance (QA) Specialist III is an advanced level position with hands-on QA experience. Working independently and under minimal supervision, the individual will be working primarily in quality operations, providing quality assurance support to CMC teams, and to in-house DS and DP production, QC testing and systems. The individual will be interacting with cross-functional groups such as Materials Management, Validation, Quality Control, and Manufacturing. Reporting to: Sr. Manager, Quality Assurance Location: Newark, CA - onsite Salary Range: $90,000 - $105,000 annually + annual performance bonus * the final salary offered will depend upon factors that may include but are not limited to the quality and length of experience, education and geographic location. Responsibilities/Essential Duties: Perform a wide variety of quality assurance activities to ensure compliance with Revance procedures, applicable US and international regulatory requirements for biologic drug substances and drug products under clinical development and commercial manufacturing. Perform incoming quality attribute inspections; review and disposition of incoming raw materials (e.g. chemicals, packaging and labeling materials, components, etc.). Review documents such as standard operating procedures, master batch records, packaging and labeling records, sampling plans, test methods, qualification protocols, and reports. Review executed production batch records and associated documentation, including any deviation and investigation reports related to lot release. Review of Quality Control, Analytical Development, and Validation protocols and reports. Perform routine sampling and support the reserve sample program. Perform area approval, line clearance, and product inspection. Perform product complaints investigations. Actively update department databases to ensure up-to-date reporting of metrics. Support continuous improvement of quality operations and department databases; author new, review existing, and may review department procedures and/or forms. Support quality systems as needed (e.g. issue and track closure to change controls, deviations, quality investigations, CAPAs). Assist with inspection preparation room for regulatory agency inspection or third-party audits. Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, lab investigations, CAPAs and change controls; review and may approve quality system documents related to manufactured products. Assist in data verification of DS and DP sections of regulatory submissions as needed. Assist with internal compliance audits as needed. Basic Qualifications: Bachelor's degree & 4-6 years' directly related experience. Preferred Qualifications: Bachelor's degree in biology, chemistry, or related science. Minimum 4-6 years' experience in the pharmaceutical or biotechnology industries, with at least 4 years working in direct manufacturing, Quality Control, or Quality Assurance; experience in aseptic manufacturing processes. Able to work with all levels cross-functionally. Good working knowledge and understanding of 21 CFR Parts 210, 211, 600, Eudralex Volume 4 and related Annexes, and ICH guidance documents. 6 years' experience in the pharmaceutical or biotechnology industry with at least 4 years working in quality operations involving aseptic fill, finish, and packaging operations. Excellent interpersonal, verbal, and written communication skills. Good working knowledge of quality systems cGMP standards applicable to commercial biologics DS and DP. Works independently with minimum supervision to accomplish goals. Relies on extensive experience and judgement to resolve simple to moderately complex issues. Able to organize and manage multiple tasks in a fast-paced environment, with no instruction on routine work and general instructions on new assignments. Prior experience with regulatory inspections. Specific vision abilities required by this job include passing a vision test in order to perform statistical inspections of drug products. While performing the duties of this job, the employee is regularly required to stand or sit, converse and listen to individuals, use arms and legs to transfer materials from one location to another, and use hands and fingers to operate a computer and telephone keyboard. This job will require the employee to be able to multi-task different activities and be able to perform duties with attention to detail. The business office has moderate noise from computers, phones, printers, and people traffic. Company Summary: 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. Flexible PTO, holidays, and parental leave. Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, 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 title: QA Specialist Department Division/Location: FLSA Status Quality Assurance Ontario, CA , USA Non-Exempt Position Reports To: Effective Date of Job description: Alternate Lourdes Gonzalez 7-16-2020 Lourdes Gonzalez POSITION SUMMARY A Quality Assurance Specialist performs any kind of testing and validation that will ensure food safety. The tasks will include support project efforts. This position will involves constant improvement of the operations processes. It will also operate as a member of the cross-departmental teams and projects if necessary. EDUCATION Elementary/Some High School High School/GED Post Secondary Education Bachelor's Degree/Master's Required Preferred Required Preferred Required Preferred Required Preferred Certifications: SQF Practitioner HACCP Required Preferred Required Preferred Required Preferred EXPERIENCE Years: 2-5 Special Focus of: Food Manufacturing SKILLS REQUIRED Detail-oriented individuals with analytical minds and strong communication skills. This position should demonstrate the following: Technical Skills - Understanding quality assurance as well as production technologies and systems is crucial in this role Computer Skills - Knowledge of Microsoft Office Suite programs, such as Word and PowerPoint, is necessary for QA specialists to produce documents, reports, and presentations Commercial Awareness - These specialists should be experts in industry standards impacting inspection and quality control techniques and procedures Communication Skills - Strong oral and written communication skills for making presentations and producing testing and quality assurance reports is necessary. Attention to Detail - The ability to detect issues from among many products and review every aspect of production operation calls for a keen eye for details. Team-Oriented - QA specialists work closely with quality control managers, production workers, quality engineers, inspectors, and other personnel Analytical Skills - Analyzing production processes and applying this skill to the inspection of products is central to this role Time Management - produce results in a timely manner. PRIMARY RESPONSABILITIES Deviation Analysis Support the analysis and corrective action of deviation that may come from process deviation, complaints, holds, etc. using root cause analysis techniques. Product and Raw Material Testing Support qualification of new product, raw materials and suppliers. Perform inspection on raw material and/or finished goods to check for defects and other product parameters to validate Plant internal programs and processes. Equipment Commissioning Support all tests related to new equipment commissioning and prepare report for further review. Process Validation Support validation plans for Plant's processes. Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems. Prepare detailed reports based on results of validation and qualification tests. Collect and analyze production samples to support process validations. Analyze quality control test results and provide feedback and interpretation to production management or staff. Performs audits of the effectiveness of development processes and products and recommends improvements as necessary Work with upper Management to identify performance improvement opportunities by analyzing quality data and documentation. Documenting/Recording Information Entering data in the QA drive to maintaining information in electronic form to facilitate data analysis. Operations Procedures Support the development of new procedures for Operations that will improvements and/or minimize errors and defects in product. Support operations processes standardization. Continuous Improvement Download quality and production information form Aptean system and perform monthly reviews and targets. Support and/or develop QA test trends and as need. Training Support Plant training program by creating training material for Quality and Production and consequently employee training. Safety Participate in, and support all safety program elements, directed towards meeting the plant's TIR (Total Incident Rate) goal established each year. This includes safety training, inspections, incident investigations, incentive programs, and any other safety-related activities. Comply with all company policies and procedures including safety rules. Food Safety and Quality Adheres to all Food Safety/Quality SOP's Communicates any known or suspected Food Safety/ Quality issues to the Production Manager or Supervisor, Q.A. Department or Management. Attends Food Safety/Quality training sessions.

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 **************************************.

ABOUT LCI The mission of LCI is to provide meaningful employment for the blind and visually impaired. We accomplish this in four ways: EMPLOY: We are one of the largest employers of people who are blind, creating meaningful careers and lasting skills that transform their lives. BUILD: We create over 2,000 products and distribute thousands more through manufacturing, retail, nationwide distribution, and e-commerce channels. SERVE: Many of our products are sold directly to the federal government. We were pioneers of “base supply centers,” stores on military bases that employ the blind and visually impaired and provide mission-critical supplies to our nation's military. SUPPORT: We want to end blindness forever. To that end, we engage in philanthropic efforts for research into blindness and treatment for the visually impaired. ABOUT THIS ROLE The Specialist, Quality Assurance is responsible for performance of Batch Record Review and Disposition function for LCI. Within that function, assure compliance with laws and regulations and in a manner consistent with best practices and applicable guidance. Responsible for performing and managing activities related to GMP document review and disposition of commercial products. This includes related activities at third-party contractors including the oversight of validation, change control, investigations and CAPA activities related to LCI products. LOCATION AND SCHEDULE Durham, NC Monday-Friday 7 AM - 3:30 PM KEY RESPONSIBILITIES Batch Review and disposition: Act as primary point of contact with third-party contract manufacturers, laboratories, suppliers, etc. to coordinate completion of all third-party records (deviations, CAPA, Change Controls, Complaints, Validation, QC test results, etc.) associated with release of LCI batches. Review and approve Master Batch Records. Perform the review of records and determine disposition of: Medical Devices Packaged/Labeled Medical Devices Clinical Product Investigations and CAPAs. Perform the review of Testing Specifications. Validation Coordinate and monitor validation activities. Provide support during regulatory inspections of GMP Contractors and LCI facilities. Assist in performing inspection readiness activities. Review Quality Agreements. Maintain current understanding of laws & regulations applicable to the pharmaceutical/biotechnology industry. Provide updates to Manager, BioMed Operations. QUALIFICATIONS Bachelor's Degree in a life science-related discipline or equivalent work experience. Minimum of 3 years of GMP quality assurance experience, including hands-on experience in Quality Operations, batch record review, disposition, and/or validation. Experience in working with third-party contract manufacturers, laboratories, and packagers. Knowledge of pharmaceutical industry regulatory requirements. High level of familiarity with practices needed to maintain compliance in the areas of batch record review, disposition, and validation and an ability to assess risk and develop solutions. Ability to exercise strong risk-based business judgment. Ability to collaboratively with a high sense of teamwork across diverse functions, operate independently and build strong networks throughout the corporate organization. Demonstrated ability to work with high integrity and an unwavering commitment to our corporate value of Quality. Works in a transparent and open manner in all aspects of the role and in all aspects of managing partnerships and relationships both internally and externally Good investigation and monitoring skills. Current knowledge of QC testing methods. Attention to detail and implementation of good documentation and GMP processes is essential. Excellent communication skills required and must be computer literate. Ability to effectively communicate with all levels of employees and external business associates, comfortable creating and delivering presentations. Why LCI? Purpose-driven company driven by principles, not profit Reach your highest potential: upward mobility, rewarded through hard work Competitive salary and compensation Basic Life Insurance at no cost to the employee 401(k) with match and Surplus-Sharing Plans Health, Dental, and Vision Insurance Ten paid holidays annually Paid Time Off (PTO) On-site Health and Wellness program Employee Assistance Program (EAP)

The mission of LCI is to provide meaningful employment for the blind and visually impaired. We accomplish this in four ways: * EMPLOY: We are one of the largest employers of people who are blind, creating meaningful careers and lasting skills that transform their lives. * BUILD: We create over 2,000 products and distribute thousands more through manufacturing, retail, nationwide distribution, and e-commerce channels. * SERVE: Many of our products are sold directly to the federal government. We were pioneers of "base supply centers," stores on military bases that employ the blind and visually impaired and provide mission-critical supplies to our nation's military. * SUPPORT: We want to end blindness forever. To that end, we engage in philanthropic efforts for research into blindness and treatment for the visually impaired. ABOUT THIS ROLE The Specialist, Quality Assurance is responsible for performance of Batch Record Review and Disposition function for LCI. Within that function, assure compliance with laws and regulations and in a manner consistent with best practices and applicable guidance. Responsible for performing and managing activities related to GMP document review and disposition of commercial products. This includes related activities at third-party contractors including the oversight of validation, change control, investigations and CAPA activities related to LCI products. LOCATION AND SCHEDULE Durham, NC Monday-Friday 7 AM - 3:30 PM KEY RESPONSIBILITIES * Batch Review and disposition: * Act as primary point of contact with third-party contract manufacturers, laboratories, suppliers, etc. to coordinate completion of all third-party records (deviations, CAPA, Change Controls, Complaints, Validation, QC test results, etc.) associated with release of LCI batches. * Review and approve Master Batch Records. * Perform the review of records and determine disposition of: * Medical Devices * Packaged/Labeled Medical Devices * Clinical Product * Investigations and CAPAs. * Perform the review of Testing Specifications. * Validation * Coordinate and monitor validation activities. * Provide support during regulatory inspections of GMP Contractors and LCI facilities. * Assist in performing inspection readiness activities. * Review Quality Agreements. * Maintain current understanding of laws & regulations applicable to the pharmaceutical/biotechnology industry. * Provide updates to Manager, BioMed Operations. QUALIFICATIONS * Bachelor's Degree in a life science-related discipline or equivalent work experience. * Minimum of 3 years of GMP quality assurance experience, including hands-on experience in Quality Operations, batch record review, disposition, and/or validation. * Experience in working with third-party contract manufacturers, laboratories, and packagers. * Knowledge of pharmaceutical industry regulatory requirements. * High level of familiarity with practices needed to maintain compliance in the areas of batch record review, disposition, and validation and an ability to assess risk and develop solutions. * Ability to exercise strong risk-based business judgment. * Ability to collaboratively with a high sense of teamwork across diverse functions, operate independently and build strong networks throughout the corporate organization. * Demonstrated ability to work with high integrity and an unwavering commitment to our corporate value of Quality. * Works in a transparent and open manner in all aspects of the role and in all aspects of managing partnerships and relationships both internally and externally * Good investigation and monitoring skills. * Current knowledge of QC testing methods. * Attention to detail and implementation of good documentation and GMP processes is essential. * Excellent communication skills required and must be computer literate. * Ability to effectively communicate with all levels of employees and external business associates, comfortable creating and delivering presentations. * Why LCI? * Purpose-driven company driven by principles, not profit * Reach your highest potential: upward mobility, rewarded through hard work * Competitive salary and compensation * Basic Life Insurance at no cost to the employee * 401(k) with match and Surplus-Sharing Plans * Health, Dental, and Vision Insurance * Ten paid holidays annually * Paid Time Off (PTO) * On-site Health and Wellness program * Employee Assistance Program (EAP)

Job Description About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc. 3900 Duckhorn Drive, Sacramento, CA 95834 About the Job: Title of the Position: QA Specialist As a Quality Assurance (QA) Specialist, you will play a critical role in ensuring that all products, processes, and documentation meet established quality standards, regulatory requirements, and company policies. Your responsibilities will include maintaining compliance with cGMP, GLP, and other industry regulations, safeguarding product integrity, and supporting continuous improvement initiatives. You will manage Quality Management Systems (QMS), review critical documentation, oversee training programs, and ensure adherence to organizational quality objectives. Responsibilities: Responsible for collecting and analysing information to identify actual and potential product and quality problems, to work with the Site Quality Lead Team to take appropriate and effective corrective and preventive actions, and to verify and validate the effectiveness of CAPA. Leads, mentors, and coaches operations and support personnel on the Change control, deviation management system and CAPA program. To drive complete root cause investigations and ensure assignment of corrective and preventive actions to eliminate the root causes of a detected issue or other undesirable situation to prevent reoccurrence. Create and maintain the CAPA program, through working cross-functionally with all area/function owners to include data sources that identify existing as well as potential problems. Compile and present CAPA program health metrics to the Site Quality Lead Team with proposed actions. Monitor deviation and CAPA performance to ensure investigations and associated CAPA are completed in a timely manner. Act as a site instructor for Change control, Deviation Management and CAPA courses. Coaches lead investigators on technical writing. Authors periodic reviews and acts as Subject Matter Expert for site CAPA and Deviation Management procedures. Supports and initiates deviations, trends, or other technical investigations, as applicable. Engages site personnel in the relationship between the CAPA program and resulting product and process improvement and enhanced product and process understanding. Effective implementation of electronic Quality Management system (eQMS) across organizations. To perform additional duties assigned by the reporting manager. Qualifications: Education/Experience: Bachelor's degree in a relevant field such as Pharmacy, Chemistry, Microbiology, Biotechnology, or a related discipline. Minimum 1-3 years of experience in Quality Assurance or a related field in a regulated industry (pharmaceuticals, biotechnology, or healthcare preferred). Knowledge, Skills, and Abilities: Strong knowledge of cGMP, GLP, and quality standards such as ISO 9001. Proficiency in managing Quality Management Systems (QMS). Familiarity with laboratory instruments and analytical methods. Experience with document control processes and regulatory audits. Excellent attention to detail and strong organizational skills. Effective communication and interpersonal skills for collaboration across departments. Strong analytical and problem-solving abilities. Ability to work independently and as part of a team in a fast-paced environment. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and QMS software tools. Requirements: Legally authorized to be employed in the United States Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: Pay range $25.0 per hour to annual salary of $70,000 Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

About the Company: Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare. Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence. Job Location: Nivagen Pharmaceuticals Inc. 3900 Duckhorn Drive, Sacramento, CA 95834 About the Job: Title of the Position: QA Specialist As a Quality Assurance (QA) Specialist, you will play a critical role in ensuring that all products, processes, and documentation meet established quality standards, regulatory requirements, and company policies. Your responsibilities will include maintaining compliance with cGMP, GLP, and other industry regulations, safeguarding product integrity, and supporting continuous improvement initiatives. You will manage Quality Management Systems (QMS), review critical documentation, oversee training programs, and ensure adherence to organizational quality objectives. Responsibilities: Responsible for collecting and analysing information to identify actual and potential product and quality problems, to work with the Site Quality Lead Team to take appropriate and effective corrective and preventive actions, and to verify and validate the effectiveness of CAPA. Leads, mentors, and coaches operations and support personnel on the Change control, deviation management system and CAPA program. To drive complete root cause investigations and ensure assignment of corrective and preventive actions to eliminate the root causes of a detected issue or other undesirable situation to prevent reoccurrence. Create and maintain the CAPA program, through working cross-functionally with all area/function owners to include data sources that identify existing as well as potential problems. Compile and present CAPA program health metrics to the Site Quality Lead Team with proposed actions. Monitor deviation and CAPA performance to ensure investigations and associated CAPA are completed in a timely manner. Act as a site instructor for Change control, Deviation Management and CAPA courses. Coaches lead investigators on technical writing. Authors periodic reviews and acts as Subject Matter Expert for site CAPA and Deviation Management procedures. Supports and initiates deviations, trends, or other technical investigations, as applicable. Engages site personnel in the relationship between the CAPA program and resulting product and process improvement and enhanced product and process understanding. Effective implementation of electronic Quality Management system (eQMS) across organizations. To perform additional duties assigned by the reporting manager. Qualifications: Education/Experience: Bachelor's degree in a relevant field such as Pharmacy, Chemistry, Microbiology, Biotechnology, or a related discipline. Minimum 1-3 years of experience in Quality Assurance or a related field in a regulated industry (pharmaceuticals, biotechnology, or healthcare preferred). Knowledge, Skills, and Abilities: Strong knowledge of cGMP, GLP, and quality standards such as ISO 9001. Proficiency in managing Quality Management Systems (QMS). Familiarity with laboratory instruments and analytical methods. Experience with document control processes and regulatory audits. Excellent attention to detail and strong organizational skills. Effective communication and interpersonal skills for collaboration across departments. Strong analytical and problem-solving abilities. Ability to work independently and as part of a team in a fast-paced environment. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and QMS software tools. Requirements: Legally authorized to be employed in the United States Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius) Benefits: Pay range $25.0 per hour to annual salary of $70,000 Yearly bonus eligibility Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage Paid time off plan 401k savings plan Additional Information: Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Division Automation Function Other USA, Denver Making complexity accessible At Mikron we are committed to delivering the best assembly systems and all needed services throughout your product's entire life cycle. With our extensive engineering know-how, complex process expertise, scalable platforms and lifelong support we are driving lasting success for your business. With more than 4,000 assembly and test systems in use worldwide, our team of over 800 qualified employees have unique process expertise and the rigor for complex project management in a wide range of industries. Mikron experts will work closely with you to design an automated assembly system that meets your unique, industry-specific processes, whether for high-volume, medium-volume or lab-scale production. Mikron's standard systems are scalable and customizable to meet your current needs and adapt to future production requirements, without the need for costly and extensive future upgrades. Your main tasks The Quality Assurance Specialist is responsible for assure products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations. Essential Duties & Responsibilities * Perform internal audits and author internal audit reports * Lead CAPA investigations * Verify effectiveness of CAPA actions * Close Non-Conforming Reports and Engineering Change Control Reports * Participate in customer audits and ISO audits * Perform supplier audits and author supplier audit reports * Provide ISO 9001 orientation training for new hires * Gather and analyze quality metrics and key performance indicators to identify trends and risks * Train employees to processes and procedures * Author customer Quality Agreements * Maintain and develop standard operating procedures to support the Quality Management System * Support and/or Lead Continuous Improvement initiatives * Assist other departments with the creation and revision of controlled procedures * Perform ad hoc duties as needed Company Responsibilities * Keeps a Customer focus when performing work and communicating both with internal and external customers * Is always striving to better themselves by taking personal responsibility to learn and grow while helping the department adapt and grow while maintaining a positive and professional attitude. * Maintains Customer Confidentiality * Values Teamwork and Collaboration * Leadership * Strengthens Accountability * Builds Effective Teams * Motivates and Develops others * Manages Conflict * Leads with Ethics * Strong attention to detail * Flexible with the ability to remain highly organized while addressing diverse responsibilities and maintaining workload Required Education, Experience, Knowledge, & Skills * Bachelor of Arts or Bachelor of Science degree * Or 3 to 5 years relevant experience * Thorough understanding of the ISO 9001 * Knowledge of ISO 13485 and IS0 45001 regulations * Familiar with Microsoft Office tools * Ability to adapt to priority changes * Ability to communicate in an open, clear, precise, and effective manner with customers, peers, and management * Must have initiative to learn and demonstrate positive behavior toward teamwork * Strong problem solving, analytical, and organizational skills * Strong written and oral communication skills * Certified Quality Auditor * Six Sigma or Green Belt certifications Additional Requirements * Must be eligible to work in the United States, have a valid state driver license and be eligible to obtain a passport for international travel * Ability to fluently speak, read and write in English. * Must be able to travel or work flexible hours as required for project deliverables. * Mikron Corporation Denver is a drug free working environment. * Must be able to work on-site at least three days per week at Mikron Automation's facility. Remote work may be permitted for up to two days per week, subject to project requirements and team alignment. Company Offered Benefits * PTO * 10 paid holidays (1-2 floating holidays depending on start date) * Pet Insurance * Excellent Medical, Dental, and Vision insurance * Short Term Disability, Long Term Disability, Life Insurance & ADD * FSA, HSA * Eligible for Over Time * Employee Assistance Program * 401k with matching up to 5%, immediately vested * Tuition and Continuing Education Reimbursement * Professional Growth Opportunities Work Environment * Noise level in the work environment is usually moderate as in a typical office setting. * Ability to work flexible hours. * Mikron Corporation Denver is a drug free working environment. * This job will close on 02/06/2026 all applications will be accepted through 02/06/2026* Pay Range * $32 to $36 an hour If you are interested what you have read and want to join our team, we would be keen to hear from you! Apply

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions-offering long-term opportunities to grow and make an impact. Your Role: Scope and Purpose of Position This person will support the QA Department with all Training and Document Control duties. Your Profile: Responsibilities Ensure GMP/ISO compliance in all documentation control activities to meet customer's expectation based on Quality Management System (QMS) requirements. Administrate the local Training System according to site, corporate, and regulatory standards to include: building of required system assets (e.g., training materials, classes, curricula) based on input from the different department management, technical and administrative support to users, processing of completed trainings, management of training records, organization / execution of site training objectives and requirements (e.g., Annual GMP Training), and monitor / report training status. Assist in the administration of Document Control / Document Management System according to site, corporate and regulatory standards to include: processing of document revisions/implementations, periodic review of documents, retrieval and archiving of documents, and security of physical document storage and electronic copies Assist in the management of the Document Control area to ensure security and availability of materials and supplies to accomplish the Document Control mission Assist in the management of the logbook program ensuring timely issuance and reconciliation of logbooks Assist in the maintenance and execute of the filing system for the manufacturing documentation, to include: issuance of batch records, archival of executed batch records, and return of customer owned documents Provide sound Quality guidance and enforcement of Document Control and Training procedures and fundamentals Provide training on Document Control owned and Training systems. Support the Quality Unit during customer and regulatory audits and inspections Any and all other duties as assigned by immediate supervisor. Required Knowledge, Skills and Abilities Understanding of GMP at an academic and conceptual level and adherence at a tactical level Understanding of training fundamentals for effectiveness and compliance Understanding of document control fundamentals Customer service with focus on order and request fulfillment Strong organizational, records/database management, and area housekeeping skills Good computer literacy with particular focus on Windows platform and applications such as Adobe and Office (Word, Excel) Good oral and written business communication Public speaking Ability to lift 15 to 25 lbs. Required Education and Experience Bachelor's Degree or equivalent combination of education and experience 4 years working in a Quality role in a GMP environment / 8 years if previous experience is non-Quality role Your Benefits: Paid Time Off, Health Insurance, Retirement Planning Target Range: $75 - $90K Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.

YOUR PASSION, ACTIONS & FOCUS is our Strength Become one of our Contributors Join the KnipperHEALTH Team! The Quality Assurance Associate, maintains quality standards by performing routine incoming, in process and finished product inspections; approving incoming materials, in-process, and finished products; recording quality results. Enforces compliance with Knipper Quality Policy, SOP's, cGMP, Operations Work Order Instructions, and all safety measures. Full Time 100% On-site Role, Based out of Charlestown, Indiana Must be available to work the hours of 11:30am-8pm ET Monday-Friday. Previous quality assurance experience preferred. Responsibilities Performs incoming material and product inspections (including returned product as necessary) in accordance with documented procedures and sampling plans. Performs line clearance activities in accordance with documented procedures, including assuring that appropriate materials/products are present for a job, paperwork is reviewed and understood, line set-up complies with cGMP and company SOPs; performs first piece inspection for conformance to written specifications (Operations Work Instruction) and sample; documents the results of line clearance inspections performed. Performs random and scheduled inspections of print, assembly and kitting activities in accordance with documented procedures; documents the results of such line inspections when performed. Documents all inspection results by completing reports and logs; verifying same is completed by assembly personnel as required; escalates nonconformance found during incoming inspections accordingly. Maintains safe and healthy work environment by following standards and procedures. Updates job knowledge by participating in educational opportunities; routinely reading standard operation procedures (SOPs), Department Work Instructions (WIs) and Operations Work Instructions. Accomplishes Knipper quality mission by adhering to all quality standards. Reports all concerns and questions to management. Review reconciliation of product and/or components in assembly and fulfillment Reviews and maintains all quality assurance inspection documentation and inspection logs. Reviews and maintains all quality system paperwork involved with incoming inspection, line inspections, return inspections, assembly / production, and distribution activities in conformance with good documentation practices are readily retrievable. May escort vendors for pest control, scale calibration and environmental monitoring. Scope of responsibilities include: RECEIVING; PRODUCTION/ASSEMBLY; MATERIAL AND PRODUCT DESTRUCTION AND RECYCLING; DEA; PRINT This job function has no supervisory responsibilities. The above duties are meant to be representative of the position and not all-inclusive. Qualifications MINIMUM JOB REQUIREMENTS: Education/Training: High School Education or general education degree minimum. Preferred: Three months prior QA experience; experience in a regulated industry. KNOWLEDGE, SKILLS & ABILITIES: Good written and oral communication skills. Basic computer knowledge to include: Outlook, Word, Excel, etc. Ability to use a calculator to perform basic math functions and understands the concept of same including: add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals; compute ratio, rate and percent. Ability to carefully monitor activities using as appropriate, instruments, gauges, and processes. Preferred: Working knowledge of current Good Manufacturing Practices. PHYSICAL DEMANDS: While performing the duties of this job the employee is: Frequently required to stand or sit. Frequently required to stoop, kneel, or crouch. Frequently required to reach with hands and arms. Frequently lift and/or move objects up to 20 pounds. Occasionally lift and/or move objects up to 35 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Knipper Health is an equal opportunity employer.

Company Profile: At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We've successfully launched this innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients. The TMF Document Specialist is responsible for owning and overseeing the management and quality control of Trial Master File (TMF) documentation across multiple Phase I-IV global studies. This hands-on role involves leadership in document management processes, ensuring compliance with regulatory requirements, and providing expert guidance to project teams. The TMF Document Specialist will play a key role in inspection readiness, process improvement, and training initiatives. The TMF Document Specialist works closely with cross-functional teams, including Clinical Operations, Quality Assurance, Regulatory Affairs, and vendors/CROs to ensure the accuracy, completeness, and timeliness of TMF documentation. TMF Document Management & Oversight Strategically manage the document lifecycle in Veeva Vault eTMF, including creation, version control, review, approval, and archival, ensuring alignment with study timelines and regulatory requirements. Lead and perform milestone TMF reviews, ensuring that all required documents are accurately filed, complete, and accessible. Serve as a hands-on TMF expert, guiding staff and study team members on best practices in document management. Ensure that all TMF documentation meets regulatory standards and internal SOPs, proactively identifying and addressing potential compliance risks. Lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps. Work closely with functional areas and the TMF Manager to implement corrective actions and prevent future issues; support implementation of corrective actions, as needed. Identify eTMF trends and commonly misfiled documents. Lead the creation and delivery of targeted training sessions for the TMF Community including guiding key document attributes (i.e., classification of documents) and resolution of document queries. Oversee the proactive management of clinical documentation and trackers, ensuring that all documentation is up-to-date, compliant, and readily accessible. Supports TMF System Administrator with activities related to TMF Migrations, such as QA Testing or Data Enrichment. Project Team Support Act as a senior liaison between vendors/CROs, and study teams, providing expert guidance and support on TMF documentation requirements throughout the study lifecycle. Collaborate with internal stakeholders to gather and provide critical information needed for the execution of the Expected Document List (EDL) requirements and expected numbers, ensuring alignment with Study Specific TMF Plan and TMF Index. Serve as the Subject Matter Expert (SME) for TMF documents, providing consultation and guidance to study teams and TMF operations on complex document management issues, in both an insourced and outsourced model. Provide oversight of vendor/CRO TMF deliverables, including quality and adherence to contractual expectations. TMF Metrics & Reporting Lead the monitoring of TMF processing metrics, ensuring that documents are processed, reviewed, and submitted in a timely manner. Use data-driven insights to identify areas for improvement. Track and report on key performance indicators (KPIs) related to TMF quality, compliance, and processing efficiency. Provide strategic recommendations to improve TMF processes. Provide regular TMF/eTMF status updates during Clinical Project Team Meetings and Clinical Operations Team meetings. Inspection Readiness Ensure the TMF complies with all applicable regulatory requirements and guidelines. Prepare for and support regulatory inspections and audits related to the TMF, including preparation of documentation. Partner with Quality Assurance to build inspection readiness practices appropriate for a growing organization. Qualifications Bachelor's Degree Required. 3+ years of hands-on Veeva Vault eTMF experience required. 5+ years of experience working directly in TMF Operations within the clinical research or pharmaceutical industry. Experience in a start-up with global clinical trials is highly desirable. TMF Certification or TMF training optional but preferred (e.g., DIA's TMF Certificate Program. LMK TMF University) or other relevant certifications. Key Skills, Abilities, and Competencies Working knowledge of clinical research documents across Research and Development (i.e., Regulatory, Clinical Supplies, Drug Safety, Biostatistics, etc.). Experience in managing TMF documents during audits or regulatory inspections. Extensive experience in TMF management, with a deep understanding of GCP, GDP, ALCOA+ standards, and regulatory requirements. Basic understanding of study and site management and overall trial planning and execution. Basic understanding of ICH-GCP guidelines and FDA/MHRA/EMA/PMDA regulations. Familiarity with MS Word, MS Excel (strongly preferred), and MS PowerPoint. Core Competencies Ability to work independently and collaboratively, taking ownership as required, in a fast-paced, evolving matrixed team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills with the ability to manage ambiguity and shifting priorities and deadlines. Strong work ethic, organizational skills, oral and written communication skills, a ‘can do' approach, problem-solving skills, and team player skills. Ability to multi-task and manage several projects in parallel while paying attention to detail. Strong critical thinking skills and ability to contribute creative yet practical solutions to problems. The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.

Company Profile: At Verastem Oncology, we're advancing innovation and addressing the urgent needs of patients living with cancers driven by RAS/MAPK pathway mutations, a key driver of tumor growth and treatment resistance. The FDA approval of AVMAPKI FAKZYNJA CO-PACK delivered the first therapy specifically for women living with recurrent KRAS-mutated low-grade serous ovarian cancer, a rare cancer with significant unmet need. We've successfully launched this innovative combination therapy in the U.S. and are exploring regulatory pathways for Europe and Japan. We are continuing to advance our pipeline of drugs that we believe will help block cancer cell survival, inhibit tumor growth, and overcome treatment resistance. With clinical trials underway, we have an exciting opportunity to shape the future of cancer care and make a meaningful impact in the lives of patients. The TMF Document Specialist is responsible for owning and overseeing the management and quality control of Trial Master File (TMF) documentation across multiple Phase I-IV global studies. This hands-on role involves leadership in document management processes, ensuring compliance with regulatory requirements, and providing expert guidance to project teams. The TMF Document Specialist will play a key role in inspection readiness, process improvement, and training initiatives. The TMF Document Specialist works closely with cross-functional teams, including Clinical Operations, Quality Assurance, Regulatory Affairs, and vendors/CROs to ensure the accuracy, completeness, and timeliness of TMF documentation. TMF Document Management & Oversight * Strategically manage the document lifecycle in Veeva Vault eTMF, including creation, version control, review, approval, and archival, ensuring alignment with study timelines and regulatory requirements. * Lead and perform milestone TMF reviews, ensuring that all required documents are accurately filed, complete, and accessible. * Serve as a hands-on TMF expert, guiding staff and study team members on best practices in document management. * Ensure that all TMF documentation meets regulatory standards and internal SOPs, proactively identifying and addressing potential compliance risks. * Lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps. Work closely with functional areas and the TMF Manager to implement corrective actions and prevent future issues; support implementation of corrective actions, as needed. * Identify eTMF trends and commonly misfiled documents. Lead the creation and delivery of targeted training sessions for the TMF Community including guiding key document attributes (i.e., classification of documents) and resolution of document queries. * Oversee the proactive management of clinical documentation and trackers, ensuring that all documentation is up-to-date, compliant, and readily accessible. * Supports TMF System Administrator with activities related to TMF Migrations, such as QA Testing or Data Enrichment. Project Team Support * Act as a senior liaison between vendors/CROs, and study teams, providing expert guidance and support on TMF documentation requirements throughout the study lifecycle. * Collaborate with internal stakeholders to gather and provide critical information needed for the execution of the Expected Document List (EDL) requirements and expected numbers, ensuring alignment with Study Specific TMF Plan and TMF Index. * Serve as the Subject Matter Expert (SME) for TMF documents, providing consultation and guidance to study teams and TMF operations on complex document management issues, in both an insourced and outsourced model. * Provide oversight of vendor/CRO TMF deliverables, including quality and adherence to contractual expectations. TMF Metrics & Reporting * Lead the monitoring of TMF processing metrics, ensuring that documents are processed, reviewed, and submitted in a timely manner. Use data-driven insights to identify areas for improvement. * Track and report on key performance indicators (KPIs) related to TMF quality, compliance, and processing efficiency. Provide strategic recommendations to improve TMF processes. * Provide regular TMF/eTMF status updates during Clinical Project Team Meetings and Clinical Operations Team meetings. Inspection Readiness * Ensure the TMF complies with all applicable regulatory requirements and guidelines. * Prepare for and support regulatory inspections and audits related to the TMF, including preparation of documentation. * Partner with Quality Assurance to build inspection readiness practices appropriate for a growing organization. Qualifications * Bachelor's Degree Required. * 3+ years of hands-on Veeva Vault eTMF experience required. * 5+ years of experience working directly in TMF Operations within the clinical research or pharmaceutical industry. Experience in a start-up with global clinical trials is highly desirable. * TMF Certification or TMF training optional but preferred (e.g., DIA's TMF Certificate Program. LMK TMF University) or other relevant certifications. Key Skills, Abilities, and Competencies * Working knowledge of clinical research documents across Research and Development (i.e., Regulatory, Clinical Supplies, Drug Safety, Biostatistics, etc.). * Experience in managing TMF documents during audits or regulatory inspections. * Extensive experience in TMF management, with a deep understanding of GCP, GDP, ALCOA+ standards, and regulatory requirements. * Basic understanding of study and site management and overall trial planning and execution. * Basic understanding of ICH-GCP guidelines and FDA/MHRA/EMA/PMDA regulations. * Familiarity with MS Word, MS Excel (strongly preferred), and MS PowerPoint. Core Competencies * Ability to work independently and collaboratively, taking ownership as required, in a fast-paced, evolving matrixed team environment consisting of internal and external team members. * Analytical thinker with excellent problem-solving skills with the ability to manage ambiguity and shifting priorities and deadlines. * Strong work ethic, organizational skills, oral and written communication skills, a 'can do' approach, problem-solving skills, and team player skills. * Ability to multi-task and manage several projects in parallel while paying attention to detail. * Strong critical thinking skills and ability to contribute creative yet practical solutions to problems. The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, location, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.

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

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.