Vaccine Quality Professional (Weekend Schedule, Friday-Monday - First Shift 0600-1600)

Employer
Pfizer
Location
Kalamazoo, Michigan
Posted
Sep 28, 2021
Ref
4826539
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
ROLE SUMMARYThis posting is for a position in the Vaccine (Vx) Drug Product Quality Assurance  team (Weekend, Friday-Monday, first shift)  providing real time quality impact support (floor support), investigation support, reviewing and approving master records, and other QA functions for the Vaccine Drug Product processing area. This role is part of the greater DP QA team, whose responsibility is to ensure timely release of conforming Drug Product, upholding cGMPs as well as timely completion of  non-conformance investigations reports with effective corrective/preventative actions (CAPA).ROLE RESPONSIBILITIES Primary responsibilities are twofold: Batch record review  and investigations/floor support (Primary Batch Record Review with Investigation/Triage Support)Batch record review
  • Review and approve Vaccine Drug Product manufacturing records (both simple and complex) to ensure that the information and documentation conforms to Pfizer policy and cGMP’s
  • Communicates errors to appropriate parties and facilitates corrections
  • Works with Operations to correct and reduce errors through effective communication and continuous improvement initiatives
  • Tracks and communicates status of tickets to key stakeholders
  • System Interface (LRT, LIMs, SAP, PacOne, QTS, PDOCs, etc.)
  • Drive continuous improvement initiatives to support the overall attainment goal
  • Supports IMEX initiatives within the team.
  • Real time (on production floor) record review
Floor Support
  • Maintains Quality Systems and ensures that products conform to regulatory, compendial and Pfizer Quality Standards.
  • Independently provide Real Time Quality impact assessments and decisions on vaccine manufacturing issues
  • Ability to independently handle complex and detailed situations (i.e. quality assurance reports, record comments, significant investigations)
  • Accurately communicate Supply/Operational needs/perspectives as well as QO perspectives for issue resolution.
  • Effectively leads/facilitates/participates/completes cross-functional team investigations for deviations.
  • Utilize tools such as Method 1 and Pfizer Human Performance (PHP) tools in the course of the investigations
  • SME support during Regulatory audits including contributions to strategies to successfully respond to auditor concerns
  • Participates in internal GMP audits
  • Able to resolve low complexity quality issues and make simple batch disposition decisions with guidance and coaching.
Other Responsibilities
  • Training new colleagues – batch record review and introduction to investigations
  • Supporting CI projects
BASIC QUALIFICATIONS Education: BS in Chemistry, Biology, Microbiology, Engineering or other science related disciplineExperience: 1-2 years of pharmaceutical manufacturing or related experience.  Quality Assurance experience highly desired.Experience in a cGMP environment, with a working knowledge of a variety of Kalamazoo quality systems and processes. Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.Strong analytical and problem solving abilities.

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

Weekend Schedule, Friday-Monday; First shift 0600-1600

  • Other Job Details:
  • Last Date to Apply for Job:  October 12, 2021
  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus

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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