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QC Manager


Andover, MA
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Job Details

Job Title QC Manager

JobID 1050317-1852

Location: Andover, MA

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

*Role Description*

The qualified candidate will provide oversight, management and analytical technical leadership of multiple projects for Raw Materials in support of Biotech manufacturing in a Quality Control Technical support lab. The oversight will include testing in support of method validation/qualification/verification activities, troubleshooting activities, method development activities, lab compliance and meeting customer timelines. The position includes people leading, employee development, performance reviews and establishing training plans. The manager will help drive department goals, objectives and prioritization through project planning/management.


Key responsibilities:*Responsible for cGMP compliance and inspection of labs and ensuring that all compendial (USP,EP, JP) testing requirements are being met. Review and approval of documentation associated with method validations/qualification/verification, investigations, change controls and technical reports.*Manage staff responsible for raw material methods development and validations/qualification as well compendia method verifications. Manage staff responsible for foreign particle ID testing in support of manufacturing and laboratory investigations and projects. Collaborate with colleagues and staff to drive department goals and objectives and prioritize work.*Develop a continuous improvement culture within labs. Oversee and guide lab analysts on continuous improvements tools including implementation of new technologies.*Provide technical and scientific guidance to Material program (harmonization of compendia, risk assessments, etc.), investigations / troubleshooting. Point of contact for Technical support for raw materials. Collaborate with site functional areas and customers to support site goals, objectives and timelines.*Work in close collaboration with the QC raw materials routine testing group.


*MS/PhD in chemistry, biochemistry or related discipline with 8-10 plus years in raw material method development/verification/qualification/validation.*A minimum of 2 plus years of leadership/management experience *Demonstrated leadership skills in coaching, development, decision making, planning and prioritization.*Extensive knowledge in the application of compendial (USP,EP,JP) methods and experience with a wide range of analytical techniques including but not limited to GC, FT-IR, ICP, NIR, UV/Vis, IC, Raman spectroscopy wet chemistry, limit tests, Karl Fisher and titrations.*Strong knowledge and experience with Compendia methods (USP and EP, JP desired), cGMP, industry standards, regulatory audits and ICH guidelines related to validation*Strong technical writing skills and communication skills*Candidate must be self-motivating, be able to adapt to rapidly changing project priorities and work collaboratively on a cross-functional team.*Understanding of Continuous improvement tools desired PHYSICAL/MENTAL REQUIREMENTS Normal sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (laboratory, suites, etc.). Position is first shift Monday through Friday.

*EEO & Employment Eligibility*

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

*QC Manager*
*Andover, Massachusetts*

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