Pfizer QC Supervisor, Microbiology in Andover, Massachusetts
The Quality Control Microbiology group is seeking a highly motivated candidate to provide oversight and support to a team focused on both product testing and microbial identification. The supervisor will oversee a group of direct reports responsible for bioburden and endotoxin testing of in process samples and drug substance intermediate/drug substance samples, as well as microbial identification from product, raw material, water and environmental testing. The supervisor will also be responsible for review/approval of investigations, change controls, commitments and documents and may conduct data review and approval activities. The supervisor may also conduct testing as needed to support the QC Microbiology team. Responsibilities also include ensuring audit readiness, laboratory safety, and compliance to procedures, Pfizer Quality Standards, and regulatory requirements. The supervisor will also work closely with other managers to ensure sufficient support of all testing related activities across the routine testing areas and is responsible for planning and scheduling aligned with company goals. The incumbent will also be responsible for oversight of testing conducted at contract laboratories. The supervisor will provide leadership and expertise for areas of oversight in both internal and external audits. The incumbent will lead and develop their team, and work with the team to support continuous improvement initiatives.
Ensure all aspects of testing (e.g. testing and data review) are planned, scheduled and conducted to meet required timelines.
Review and approval of GMP documentation such as data, reports, procedures.
Oversight and review/approval of investigations, CAPAs and change controls.Ensure agreed upon timelines are met.
Provide leadership and direction to a team of 5-8 analysts with varying levels of experience (both full time employees and contractors).Coach, mentor and develop staff.
Ensure alignment to all regulations and Pfizer Quality Standards related to area of oversight.
Responsible for working with other management across QCM to ensure support for all testing activities in the routine testing area.
Responsible to represent their area of oversight in internal and external audits.
Promote and deliver continuous improvement both in area of oversight and in the QCM department and Quality Organization.
Accountable for laboratory safety practice adherence.
Represent the area oversight at meetings and huddles and may represent QC Microbiology as needed.
Develop and support a continuous improvement culture and oversee/guide staff on CI tools.
B.S. in microbiology or related scientific discipline with a minimum of 5 years experience in a GMP regulated environment.0-2 years of management experience.
Knowledge and practical application of relevant techniques - classic microbiology techniques as well as rapid microbial techniques.
Experience with bioburden and endotoxin testing preferred.
Experience with microbial identification (e.g. microseq, riboprinting and MALDI-TOF), including troubleshooting and data analysis is preferred.
Knowledge of GMP compliance requirements for Quality Control Laboratories
Demonstrated skills in collaboration, attention to detail, and communication skills (written and oral)
Solid understanding of continuous improvement, and development and/or implementation of best practices in Quality Control Laboratories is desired
Experience with LWLIMS, QTS and PDOCs is a plus.
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EEO & Employment Eligibility
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Other Job Details:
- Last Date to Apply for Job: 1/22/2019 Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.