MCS Associate Quality Assurance

Summary: This position will provide operational QA support of a clinical drug product packaging and labeling team. Primary responsibilities will include review and approval of printed clinical labels, finished clinical pack inspection, expiration date calculation and batch record review. Secondary responsibilities will include generation and compilation of quality data and reports (e.g. lot track/trace, deviations). Individual will also assist with procedure reviews and initiation of deviation reports. There is the potential for role expansion into support of a product distribution function. Day to Day Responsibilities: Staff member will provide daily quality oversight and partnership in a clinical drug product packaging and labeling facility. Primary responsibilities will include review and approval of printed clinical labels, finished clinical pack inspection, expiration date calculation and batch record review. Secondary responsibilities will include generation and compilation of quality data and reports (e.g. lot track/trace, deviations). Must have experience with GMP processes and documentation. Without that fundamental skillset the training for document review tasks, label approval and packaging inspection will have no foundation. Must be able to methodically and meticulously inspect printed materials for print quality defects, clinical product components (e.g. syringes and vials) for physical defects, and batch record documentation for accuracy and completeness. Must be able to work in a team with shifting priorities and shifting responsibilities, such that the team members must be confident verbal communicators able to discuss responsibilities, divide them, reassess them, and potentially reassign them throughout the day or week. Top 3 Must Have Skill Sets: Direct GMP experience in biotech or pharma industry or related educational program (Biotech Program) Excellent communication skills and ability to work effectively on diverse teams Ability to problem solve and exercise complex decision making using the scientific method Ideal Candidate: Looking for candidate committed to working the duration of the contract. 5 years of QA experience in the biotech industry, with a focus on GMP compliance Hands-on experience in manufacturing, packaging, and labeling sampling for Biotech/pharma Proficiency in SAP and MES for batch record review and sampling documentation Strong attention to detail and excellent communication skills Values continuous improvement and proactively identifies areas for operational efficiency Compensation: The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location and end client requirements). Benefits and Ancillaries: Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee. Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. AditiConsulting