Quality Control Manager
Company: Randstad Pharma
Posted on: November 22, 2021
Quality Control Manager needed! Location: Wilmington MA
Permanent Opportunity Salary: 110,000 - 130,000/yr Greater Woburn
MA CRO with the goal of creating new standards of care in
therapeutic areas with high unmet medical needs is seeking (1)
highly skilled Quality Control Manager starting immediately!!
Client is looking for a detail-oriented manager to ensure our
Quality Control systems are set up properly and operate run
smoothly on a day-to-day basis, meeting quality and efficiency
standards. The right candidate will be mid-senior level and have a
proven track record of building quality control teams from the
ground up. This position requires a strong understanding of both
customer needs and internal resource management. The QC Manager
will help design, implement, and maintain GMP systems, including
testing and validation, SOP development, and training for
technicians and analysts. This role requires a strong work ethic,
excellent written and verbal communications kills, and the ability
to think outside the box. Great location off route 93 - close to
Woburn Mall which has plenty of excellent eateries and shopping. MA
Commuter rail is close by for those individuals looking to travel
in from Boston or towns north of Woburn. Easy access from southern
- Manage the development and growth of a Quality Control
department and activities.
- Oversee the development and implementation of standards,
methods, and procedures for systems and testing in compliance with
industry expectations and regulations.
- Ensure compliance with current Good Manufacturing Practices as
required by FDA and other regulatory bodies.
- Create and implement a comprehensive staff training
- Devise, improve, and review new specifications and
- Ensure that SOPs are maintained and updated for QC systems, and
operation, maintenance, and calibration of laboratory
- Instrument calibrations and validations executed in timely
- Oversee sample/standard handling, tracking, data analysis, and
- Serve as QC subject matter expert, providing guidance to senior
management as well as other departments.
- Maintain accurate and updated records. Ensure accuracy and
integrity of data analysis
- Participate in all auditing activities; in-house, vendor and
client. Ensures lab and staff are audit ready.
- Supervise analysts, technicians, specialists, and other staff
- Set the requirements for raw materials from suppliers.
- Inspect and approve or reject final outputs/products.
- BA/BS in a scientific discipline with 10-12 years' experience
in quality control OR
- MA/MS plus 6-8 years OR
- PhD plus 4-6 years' experience.
- Extensive knowledge of cGMP regulations and ALCOA+
- Strong attention to detail, observation, organizational, and
- Flexibility and adaptability to handle complex situations.
- In-depth knowledge of quality control procedures and legal
- Excellent communication skills.
- Good technical/computer skills.
Keywords: Randstad Pharma, Boston , Quality Control Manager, Executive , Wilmington, Massachusetts
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