MCS Senior Associate Quality Assurance

Senior Associate, Quality Assurance (MCS)

The manager is seeking a Senior Associate, Quality Assurance (MCS) to provide real-time, floor-based QA support at USTO site. This fully onsite role involves rotating between day and swing shifts every six months, beginning on day shift for training. 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 (preferably within biotech or pharmaceutical) 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. The manager is open to training strong candidates but will not consider those who are purely academic or significantly overqualified without clear justification.

This position supports Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas. 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.

Bachelor's Degree in Biochemistry, Biology, Chemistry, or related science field. Demonstrated ability to perform GMP operations including following detailed SOPS, maintaining training, and good documentation practices. Also, ability to make Quality based decisions in order to ensure compliance. Experience managing projects through to completion & meeting timelines. Evaluating documentation and operations according to company procedures. Experience working with Quality Systems, Strong organizational skills and ability to manage multiple tasks at one time/ Effective communication skills (both written and verbal). Demonstrated ability to work as both a team player and independently. Display leadership attributes and drive improvement initiatives.

Bachelor's degree OR Associates degree and 6 months of experience OR High school diploma / GED and 2 years of experience.

Flexibility on shifts. Attention to detail. Quality background.

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