Quality Assurance Associate II

Title: QA Associate II Location: Gainesville, FL 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. Act as QA support during Manufacturing operations. Execute room release requirements prior to the start of a manufacturing campaign. Review executed documents including MBRs, Forms, Protocols, etc. for good documentation practices. 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. Initiating Raw Material Specification form(s) for critical received raw materials. Assist with review of Preventive maintenance, calibration, and work order documentation in the asset management software. Assist in evaluating standard operating procedures, master batch records, and test methods for alignment with GMPs. 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 Quality Assurance position. Previous success in gown qualification requirements in an ISO 7 cleanroom environment. • Exposure to 21 CFR Parts 210 & 211, 21 CFR 820, and/or 21 CFR 1270, biotechnology, and electronic computer systems is desired. • 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.

Physical Demands Adjusting or moving objects weighing up to 25lbs

EOE/ADA IND123