Senior Specialist Quality Operations

Employer
Pfizer
Location
Kalamazoo, Michigan
Posted
Jun 10, 2022
Ref
4854654
Required Education
Bachelors Degree
Position Type
Full time

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

 

What You Will Achieve

This posting is for a position in the QA Drug Product Team providing quality production floor support (including on-call off shift and weekends) for the Drug Product processing area. This role has responsibility to ensure timely completion of non-conformance investigations reports with effective corrective/preventative actions (CAPA), and floor production support for the Drug Product East Areas (Inspection, Injectable Packaging, NSL Mfg, NSL LSS, and Powders).

 

How You Will Achieve It

  • Independently provide Real Time Quality impact assessments and decisions on Drug product issues

  • Handle complex and detailed situations. Applies technical skills to achieved assigned work on assignments. May act as a technical resource with the DP Quality unit. Makes decisions to resolve moderately complex problems in standard solutions.

  • Accurately assess consequences of decisions

  • Accurately assess potential Regulatory impacts on a Global basis

  • Immediately escalate issues with potential market or stability impact

  • Accurately communicate Supply/Operational needs/perspectives as well as QO perspectives.

  • Effectively leads/facilitates/participates/completes cross-functional team investigations for FARs and Significant Deviations and when applicable aids in drafting of AQRT summary

  • Utilize tools such as Method 1 and Pfizer Human Performance (PHP) tools in the course of the investigations

  • Participate in Green/Black belt projects, RFT% Improvement projects, CAPA Effectiveness, etc. as appropriate

  • Manages own time to meet agreed targets, develops plans for short-term work activities on own projects with a Work Team.

  • Applies skills and discipline knowledge to contribute to achievement of work

  • Independently assess a wide range of Change Control activities (PTVAs, Protocol development, SOP and MBR changes) to determine potential Quality and Operational GMP impacts

  • SME support during Regulatory/Customer/Internal audits including contributions to strategies to successfully respond to auditor concerns

  • Provides product knowledge and support for regulatory deficiency responses, regulatory annual reports, and the development of other regulatory submission packages.

  • Effectively communicate complex technical issues to all levels of Management (including outside of Quality), using a variety of communication tools and techniques

 

Qualifications

Must-Have

  • Bachelor's of Science Degree in Chemistry, Biology, Microbiology, Engineering or other science related discipline

  • 3+ years Experience in pharmaceutical industry

  • Experience in Quality systems

  • Sound knowledge of current Good Manufacturing Practices

  • Ability to work in a team environment within own team and interdepartmental teams

  • Experience of writing and managing deviations and/or lot release support.

  • Effective written and oral communication skills

 

Nice-to-Have

  • Experience at a manufacturing site

  • Experience of writing and managing deviations

  • Experience in LIMS, QTS, and SAP

 

Physical/Mental Requirements

Office position with time in the production environment.

Independently, with minimal guidance, consistently produces quality work. Must be able to work in a team environment within own team and interdepartmental teams. Must work under short timelines while maintaining quality work. Must have effective written and oral communication skills.

 

Non-Standard Work Schedule, Travel, or Environment Requirements

Off-shift/weekend on-call via phone


Work Location Assignment:On Premise

 

Other Job Details

  • Last Date to Apply: June 22, 2022
  • Eligible for Relocation Package: YES

 

 

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

 

 

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.

 

 

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.

 

 

Quality Assurance and Control

 

 

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