Sr QA Specialist

Seeking a Quality Assurance Specialist to join a Pharmaceutical company in the South New Jersey. This role is 100% on-site. Only local candidates will be considered. SUMMARY The incumbent assures compliance to all regulatory requirements, current Good Manufacturing Practices, and company Policies, Standard Operating Procedures and Work Instructions. ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES Reviews, approve and tracks executed production records. Reviews and approves production and QC investigations. Reviews lab sample results and manufacturing records related to qualification/validation activities. Conducts, write, and reviews quality related investigations as appropriate. Reviews and approves Master Production Records. Responsible for cGMP compliance of assigned manufacturing operations / areas. Completes QMS items as assigned. Is responsible for the conditional / final release of materials. Hosts customer and internal audits, as needed Conduct internal and external audits, as needed Participates in inspections by regulatory authorities Writes and reviews Annual Product Reviews/Product Quality Reviews Writes and reviews Product Validation / Qualification / Assessments documents. Writes and reviews Equipment Qualifications / Assessments documents. Writes and reviews Computerized Systems Validations / Assessments documents. Reviews, evaluates and approves minor equipment changes. Conducts GMP inspections. Conducts environmental monitoring. Reviews and approves CMC sections of DMFs as appropriate. Maintains QA databases for products / equipment as appropriate. Adheres to personal moral, ethical, legal, and behavioral conduct that is in compliance with the Code of Conduct. Adheres to all applicable SHE and cGMP regulations e.g. ICH Q7, FDA, 21 CFR 210 and 211, etc. EDUCATION AND EXPERIENCE A BA/BS degree in microbiology, biology, chemistry, or engineering and 3-5 years of experience in QA in a pharmaceutical manufacturing environment required, or an equivalent combination of education and experience. Thorough knowledge of cGMP in active pharmaceutical ingredient (API) manufacturing is preferable. OTHER REQUIREMENTS Must have excellent communication skills. Must be conscientious and detail oriented. Must have excellent computer skills (MS Office 365). Must be a team player. Must be able to self-manage daily work and set priorities. Must be able to manage projects and prioritize appropriately. Must be able to adhere to deadlines. Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at View email address on click.appcast.io or View phone number on click.appcast.io. Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. Everforth Apex Company Description Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico. If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our Benefits Department at View email address on click.appcast.io or View phone number on click.appcast.io. Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered. Everforth Apex Benefits Overview Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. #J-18808-Ljbffr Apex Systems