Quality Assurance Specialist III

Nature and Scope The Quality Assurance Specialist provides real-time quality oversight and support during manufacturing operations to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal procedures. This position serves as the primary quality representative on the manufacturing floor and is responsible for quality decision-making, batch record review, line clearance verification, aseptic processing oversight, and support of investigations and quality systems. 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. Provide QA oversight during manufacturing and warehouse operations. Gown in support to routinely work at controlled rooms; perform aseptic processing audits; perform quality oversights of facilities, process, and personnel; approve quality deviations. Perform line clearance activities before manufacturing and packaging operations. Perform QA review and release of raw materials, components, and other GMP materials in accordance with approved procedures. Conduct routine facility, process, and personnel GMP observations. Monitor production schedules and ensure adequate QA support coverage. Manage reserve sample inventory, storage, reconciliation, and retention activities. Review and approve technical documents including protocol/report. Author/Review/approves IQ/OQ/PQ of instruments Protocols and Reports, calibration reports, maintenance reports, OOTN, discrepancy reports, CAPAs, and CCRs as needed. Review/approves batch records, logbooks and other related cGMP documents. 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 chemistry or biology; or equivalent combination of education and experience. 8 Yrs. experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA. Broad knowledge of scientific theories, Instrumentation, and analytical techniques. Thorough knowledge of GMPs and pharmaceutical products. Working knowledge of all phases of pharmaceutical manufacturing and laboratory operations. Expertise with writing, editing, or reviewing documents such as SOPs, work instructions, batch records, guidelines, etc. Experience in providing high quality deliverables while meeting business needs. Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals. Physical Environment and Requirements Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. Employee must be able to occasionally lift and/or move up to 25 pounds. This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. A large portion of the work will be performed in the plant where the noise may be loud. Gown in support to routinely work at controlled rooms are required. Expected Salary Range: $91,000-$101,000 The salary range, displayed is the minimum and maximum annual salary range of compensation 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: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf 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 jrossini@americanregent.com 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 https://careers.americanregent.com/ 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 hrtalentacquisition@americanregent.com. Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide.

Salary : $91,000 - $101,000