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Aseptic Compliance Specialist


Saint Louis, MO
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Job Details

Job Title Aseptic Compliance Specialist

JobID 1044862-1852

Location: St. Louis, MO

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 guidance, coaching and coordination for all aspects related to the initiation, tracking, trending and management of all manufacturing investigations, corrective and preventive actions (CAPA), evaluation of CAPA effectiveness and Operational Excellence (OpEx) projects within Sterile Product Manufacturing (SPM). The incumbent will work with the Production Management and Quality Assurance to facilitate the consistent, disciplined execution of the ER/QAR quality system ensuring the completeness and comprehension of the investigations and determination of most probable root cause. The incumbent will review and analyze corrective and preventive actions effectiveness through appropriate tracking and trending methods in order to prevent reoccurrence.


*Facilitates adequate completion of manufacturing investigation efforts to ensure compliance with quality and cycle time standards. Works closely, provides guidance, coaching and feedback to all groups who are involved in initiating, completing and conducting manufacturing investigations and CAPA analysis.*Gathers and analyzes historical data to identify trends and root-cause of manufacturing deviations. Recommends corrective and preventive actions to prevent/ eliminate recurrent discrepancies and leads its implementation in Operations. Measures CAPA effectiveness.*Ensures that QAR System requirements are being executed as established in the site's SOP and corporate guidelines. Provides the necessary coaching and guidance to ensure practices are in compliance with guidelines. Is the primary contact in the resolution of conflicts and differences resulting from the resolution of MIRs.*Collaborates in the design and deployment of trainings to educate employees on how to report, initiate, conduct and close an investigation. Manages the QAR Certification Program and ensures its adequate implementation in Operations. Leads efforts to educate leaders and employees on OpEx methods, practices and tools.


Bachelor degree in Science or Engineering with 4-7 years of experience in the pharmaceutical industry working with manufacturing investigations and/or regulatory issues. Strong background and knowledge in manufacturing, compliance and technology investigations, processes and systems; or Master degree in Science or Engineering with 3-5 years of experience in the pharmaceutical industry working with manufacturing investigations and/or regulatory issues.Strong background in GMP Manufacturing, QA/QC, Aseptic Manufacturing and/or Environmental Monitoring is highly desirable. Self-starter, team player, with strong interpersonal and coaching skills. Excellent written skills in English. Good verbal communication and ability to coach and provide guidance to others. Computer literate, with superior skills in managing Excel spreadsheets (or similar database). Strong presentation skills. Proven record of problem solving, decision-making skills and application of process improvement tools. PHYSICAL/MENTAL REQUIREMENTS Able to travel between Brentwood and Westport facilities (Metro St Louis Area), when necessary.Able to meet with 2nd and 3rd shift workforce during normal off-shift hours to observe activities, collect data and/or interview staff, when necessary.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS This position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short or long-term basis. Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.Must have the ability to work effectively under and manage to strict production, time and performance deadlines.Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.#LI-SA1

*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. This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. 1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.

*Aseptic Compliance Specialist*
*St. Louis, Missouri*

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