MCS Senior Associate Quality Assurance

Payrate: $30.00 - $32.00/hr.


Summary:
The Specialist Business Systems Analyst will be a key member of the program team working towards the This role involves providing real-time, floor-based QA support at Company site, with a rotation between day and swing shifts every six months. 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.


Responsibilities:

• Provide support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff.
• Maintain a purposeful presence on the floor for real-time QA support.
• Conduct electronic batch record review and approve SOP revisions and work orders.
• Provide quality approval of minor deviations and evaluate compliance issues.
• Represent the Drug Substance Quality Assurance department in project execution to achieve operational goals.

Qualifications:

• Hands-on QA or manufacturing experience in a GMP environment.
• Bachelor's Degree in Biochemistry, Biology, Chemistry, or related scientific disciplines preferred but not required.
• Experience managing projects through to completion and meeting timelines.
• Evaluating documentation and operations according to company procedures.
• Experience working with Quality Systems.
• Strong critical thinking skills.
• Attention to detail.
• Quality background.

Desired Skills:

• Ability to perform GMP operations, follow detailed SOPs, and maintain good documentation practices.
• Strong organizational skills and ability to manage multiple tasks at one time.
• Effective communication skills (both written and verbal).
• Ability to work as both a team player and independently.
• Display leadership attributes and drive improvement initiatives.

Pay Transparency: The typical base pay for this role across the U.S. is: $30.00 - $32.00 /hour . Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.


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