Quality Assurance Associate IITitle: QA Associate II Location: Durham, NC Industry: Pharmaceutical Salary: $33/hr. and up based on experience Employment Type: Contract We are a technology-forward contract development and manufacturing organization (CDMO) that streamlines analytical development, process development, CMC consulting and early-stage GMP cell therapy manufacturing. Our focus is on developing and manufacturing immune cell therapies, including autologous and allogeneic CAR-T, CAR-NK, and CAR-M programs. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance. The contingent staff member for Quality Assurance will primarily be responsible for supporting quality operation activities. This supporter of the Quality Unit will promote a culture of compliance throughout the organization by reviewing production-related documents and assisting with quality oversight of quality events. With partnership from the QA team, they will oversee the generation and revision of product-related master documents to support GMP manufacturing of drug substances and drug products. We are looking for a mature professional capable of working independently and in a team setting who continually evaluates opportunities for improvement to increase efficiency while ensuring compliance with applicable regulatory requirements and standards. Requires the ability to produce results in a fast-paced environment to meet client deadlines and to prioritize based on criticality effectively. Essential Duties and Responsibilities
- Actively participates in fostering a positive, collaborative work culture.
- Ensuring adherence to cGMPs across the organization.
- Addresses all quality and compliance matters in an open and timely manner.
- QA inspection and release of incoming controlled and critical material from the warehouse.
- Receipt, review, and process new item forms for material procurement in Veeva.
- Author and review standard operating procedures within the electronic document management system.
- Initiating Raw Material Specification form for critical received raw materials.
- Logbook creation, review, and archival.
- Document contingency management of on-the-floor documents and bimonthly maintenance of steady state documents.
- Document issuance and maintenance of routine forms for Manufacturing, Quality Control, and Microbiology.
- Maintain QA scanned documentation and document control room organization/archival
- Assist with review of Preventive maintenance, calibration, and work order documentation in the asset management software.
- Assist with approved vendor re-qualifications and managing the approved supplier list
- Assist in evaluating standard operating procedures, master batch records, and test methods for alignment with GMPs.
- Review executed records for accuracy, completeness, and adherence to internal standards and industry regulations.
- Observe and provide oversight to the manufacturing and laboratory areas, including aseptic processing areas.
- Gown aseptically for manufacturing suites and maintain qualification for aseptic gowning.
- Complete visual inspection of parenteral products. Maintain 20/20 (corrected) visual acuity.
- Will work directly with all departments and across sites to review and track executed documents to meet timelines.
- Provide status updates and reminders when necessary.
- Other duties as assigned.
Qualifications
- HS Diploma with 7+ years of relevant industry experience
- Bachelor's degree preferred in life sciences with 2+ Years of relevant industry experience
- Prefer experience with FDA Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDP) in the pharmaceutical, biologic, medical device, or human tissue industries in a Document Control position, including the revision, issuance, and tracking of batch records, Standard Operating Procedures (SOP), Specifications, etc.
- Microsoft Word and Microsoft Excel experience
- Exposure to 21 CFR Parts 210 & 211, 21 CFR 600, 21 CFR 820, and/or 21 CFR 1270, biotechnology, and electronic computer systems is desired
- Excellent communication skills, written and verbal.
- Team player with the ability to influence others.
- Detail-oriented, excellent written and verbal communication skills
- Effectively manages cross-functional communication
- Multitasks strategically and tactically in a fast-paced work environment.
- Strong organizational skills; able to prioritize and manage complex processes/projects. Ability to define problems, collect data, establish facts, and draw valid conclusions
- Ability to function in a rapidly changing environment and balance multiple priorities simultaneously
SRG4 Life Sciences delivers flexible staffing solutions nationwide, specializing in pharmaceutical, CDMO/CMO, medical device, clinical research, PBM, pharmacy, food and beverage, nutraceutical, laboratory, and consumer product sectors. We provide contract, contract-to-hire, and direct hire placements across a wide range of critical roles including Scientists, Formulators, Engineers, QA/Regulatory Affairs, Microbiologists, Manufacturing Technicians, Supply Chain/Procurement Specialists, Project Managers, and Business Development professionals. SRG4 Life Sciences operates on a relationship-driven model-partnering closely with clients to understand not only the role, but the company's culture, goals, and vision. Our mission is to match purpose-driven professionals with organizations committed to advancing human health, building long-term partnerships that drive innovation, quality, and performance. EOE/ADA