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Senior QA Specialist


Andover, MA
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Job Details

Job Title Senior QA Specialist

JobID 1050457-1852

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 incumbent will provide second shift Quality Assurance (QA) coverage for the manufacturing and quality control assets; serving as the primary point of contact for QA during off-shift hours and providing an on-the-floor presence. The Senior QA Specialist applies sound quality assurance decision making to issues as they arise. Responsible for the review and approval of all documentation related to commercial manufacturing to ensure timely review and disposition of high quality batches/lots. Documentation review includes master and executed manufacturing batch and formulation records, environmental action reports, standard operating procedures and forms, manufacturing and laboratory investigations, change controls, etc. Leads and/or supports manufacturing and laboratory investigations to resolve routine to highly complex quality issues related product manufacture and testing. The position also provides quality assurance representation on site and network initiatives, acts as a liason to various stakeholders (site functions, regulatory affairs etc.), and acts as a point of contact and decision maker for quality and compliance issues and guidance. Responsible for activities related to setting and maintaining quality standards aligned with US FDA cGMP and other applicable international and guidance's.


*Responsible for providing quality assurance support on second shift to Manufacturing and Testing Operations relative to the production of clinical and commercial products. *Provides on-the-floor QA presence in Manufacturing and Quality Control during second shift hours.*Reviews batch records; reviews and approves protocols and reports, and authors, reviews and approves SOPs. *Reviews and approves routine to highly complex investigations, providing sound quality assurance judgment to ensure product quality. *Independently executes projects. *Works in loosely defined problem-solving situations within own work group/project team.*Exercises judgment in resolving moderate to high impact/complex quality issues.*Plans and executes work independently and consults with supervisor as needed. *Incumbent knows and applies technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.*Review and approval of deviations and resulting investigation reports, corrective actions and/or preventive actions for adequacy, logic and quality/validation/regulatory impact. *Active participant/lead for M1s/M2s; promoting and leading adherence to the DMAIC process. Champion for implementation of sound preventative actions, leveraging the Pfizer Human Performance tools. *Review and approval of change controls for appropriateness, completeness and alignment with quality, validation and regulatory expectations. *Maintains inspection readiness. *Creates and fosters collaborative customer relationships and regularly provides advice/guidance regarding quality improvements to stakeholders.*Skilled at the use of Enterprise systems including, but not limited to site Quality Tracking System (QTS), Laboratory Information Management System (LIMS), SAP and Pfizer document repositories


Bachelor of Science Degree or Masters in Microbiology, Biology, Chemistry or related Technical Physical ScienceMinimum of 10 years' experience in GMP Pharmaceutical Manufacturing environment. Previous experience in Quality Assurance, Quality Control, or Manufacturing preferred.

*Other Information - Internal*

Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

*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.

*Senior QA Specialist*
*Andover, Massachusetts*

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