Quality Control Manager

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Job description

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 NH.

Responsibilities:

• 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 program.
• Devise, improve, and review new specifications and procedures.
• Ensure that SOPs are maintained and updated for QC systems, and operation, maintenance, and calibration of laboratory instruments.
• Instrument calibrations and validations executed in timely manner.
• Oversee sample/standard handling, tracking, data analysis, and review
• 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 members.
• Set the requirements for raw materials from suppliers.
• Inspect and approve or reject final outputs/products.

Qualifications:

• 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+ principles
• Strong attention to detail, observation, organizational, and leadership skills.
• Flexibility and adaptability to handle complex situations.
• In-depth knowledge of quality control procedures and legal standards.
• Excellent communication skills.
• Good technical/computer skills.