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Aseptic Compliance Specialist ...

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Job Summary

Company
Pfizer
Location
Brentwood, MO
Industries
Other/Not Classified
Job Type
Full Time
Employee
Career Level
Experienced (Non-Manager)
Job Reference Code
4903_4696518

Aseptic Compliance Specialist - (SPM)

About the Job

ROLE SUMMARY

The Aseptic Compliance Specialist - Sterile Product Manufacturing (SPM) 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 position works 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 position will review and analyze corrective and preventive action effectiveness through appropriate tracking and trending methods in order to prevent reoccurrence. 

ROLE RESPONSIBILITIES

  • 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 Manufacturing Investigation Reports (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.
  • Supports process improvement initiatives that increase quality/compliance, efficiency and safety within the Sterile Product Manufacturing facility

BASIC QUALIFICATIONS

  • 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.   

Must be self-motivated and willing to learn new and changing responsibilities. Candidate must demonstrate commitment to values based leadership and achieving objectives in a manner that is supportive of Pfizer Core Competencies.

PHYSICAL/MENTAL REQUIREMENTS

  • Able to travel between Brentwood and Westport facilities (Metro St Louis Area), when necessary.
  • Able to work off-shift hours, meet with 2nd and 3rd shift workforce 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.

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. 

The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents (“green card holders”), Refugees and Asylees.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

Other Job Details:

  • Last Date to Apply for Job: July 31, 2018

    Eligible for Relocation Package - Yes

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

 

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