MCS Senior Associate Quality Assurance

Job Description

Target PR Range: 25-35/hr (Depending on experience).

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

The role supports the 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 staff in execution of their processes, procedures, and use of quality systems.

• Purposeful presence on the floor
• Electronic batch record review
• SOP revision & approval
• Work order approval
• Quality approval of minor deviations
• Evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion
• Represent functional area for the Drug Substance QA department in execution of projects necessary to achieve departmental operational goals and work in a 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.
• Ability to make quality‑based decisions to ensure compliance.
• Experience managing projects through to completion and 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.

High school/GED + 2 years work experience OR Associate’s degree and 6 months work experience OR Bachelor’s degree.

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Not Applicable

Full‑time

Quality Assurance

Staffing and Recruiting