MCS Senior Associate Quality Assurance; GMP - Rotational Shift

Overview

The manager is seeking a Senior Associate, Quality Assurance (MCS) to provide real-time, floor-based QA support at Client 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.

Must be flexible as it is possible the worker will start on any shift. Rotate every 6 months. Day 6am-5pm;
Swing 1pm-(12am);
Graves 7pm-8am. Will change on the business they are supporting.

• Provide real-time, floor-based QA support at the Drug Substance facility; daily oversight of the Drug Substance manufacturing areas.
• Electronic batch record review; quality approval of minor deviations.
• SOP revision & approval; work order approval.
• Purposeful presence on the floor and QA liaison during manufacturing and facility events.
• Evaluate compliance issues, provide recommendations, and assure progress of quality records to completion.
• Represent the functional area for the Drug Substance Quality Assurance department in execution of projects necessary to achieve departmental operational goals; work in a team matrix environment.

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.

• Bachelor's Degree in Biochemistry, Biology, Chemistry, or related scientific disciplines is preferred but not required.
• Hands-on QA or manufacturing experience in a GMP environment (preferably within biotech or Client) with strong critical thinking skills prioritized over academic credentials.
• Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices.
• Ability to make quality-based decisions to ensure compliance.
• Experience managing projects through to completion and meeting timelines.
• Experience evaluating documentation and operations according to company procedures.
• Experience working with Quality Systems, strong organizational skills, ability to manage multiple tasks, and effective communication skills (written and verbal).
• Demonstrated ability to work as both a team player and independently; leadership attributes and drive for improvement initiatives.

• organizational skills
• critical thinking ability
• day-to-day responsibilities on the floor supporting manufacturing, record review and approval for BRRs, Deviations and SOPs