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The manager is seeking a Senior Associate, Quality Assurance (MCS) to provide real‑time, floor‑based QA support. The position supports Clinical/Commercial drug substance production and requires cleanroom oversight, batch record review, and acting as a QA liaison during manufacturing and facility events. Ideal candidates will have hands‑on QA or manufacturing experience in a GMP environment with strong critical‑thinking skills prioritized over academic credentials. A bachelor's degree in Biochemistry, Biology, Chemistry, or related scientific disciplines is preferred but not required.
Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.
The annual [salary/hourly rate] for this position is between $35.00 -$37.00 per hour. Factors which may affect pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.