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QC Technician (2nd Shift)

Pfizer

Pfizer

Quality Assurance
Andover, MA, USA
Posted on Tuesday, September 12, 2023

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

You will be a member of Pfizer’s dedicated and highly effective Quality Control team. You will support commercial manufacturing and QC testing labs by managing sample lifecycle including bulk sample receipt, aliquot, labeling, delivery, and storage of QC test samples. Sample types may include release test, backups, retains, reference material, assay controls, and stability.

You will support and maintain the retain program as required by CFR regulations. Monitoring of environmental chambers is also critical to the storage of the above sample types.

Your contribution to the Quality Control Sample Operations team will help Pfizer provide safe drugs to patients.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

Primary responsibilities include the following:

  • Aliquot of QC analytical test samples from bulk samples in a Biological Safety Cabinet (BSC).
  • Perform pre and post aliquot quality checks and review of labels, line clearance, sample handling, and storage conditions.
  • Documentation of GMP in-process and drug substance samples in support of Quality Control release testing.
  • Adhere to SOPs (Standard Operating Procedures), cGMP (current Good Manufacturing Practices), plant safety, quality, and documentation systems requirements.
  • Coordinate receipt and delivery of samples from designated sample ports to QC laboratories or QC cGMP areas and maintain the inventory for retain samples, backup samples and reference material.
  • Maintain sample inventories.
  • Monitor and maintain QC Cold storage units.
  • Participate in on-call program - Be part of the rotation for the on-call program to support critical equipment 24/7
  • Cross train with other teams within the Quality Lab Ops. Support group
  • Represent the functional group at meetings related to projects, investigations, or issue resolution.

Qualifications

Must-Have

  • High School Diploma or equivalent with 2+ years of GMP experience or Biotechnology Certificate/Associate Degree with 0-2 years of experience working in a GMP environment.
  • Effective written, interpersonal and communication skills
  • Working knowledge of Microsoft Office applications (Microsoft Office, Outlook, Teams etc.)

Nice-to-Have

  • Knowledge of basic laboratory techniques such as working in a Biological Safety Cabinet (BSC), pipetting, aseptic technique, and basic laboratory safety practices preferred.
  • Experience with Labware LIMS is a plus.
  • Experience in a biotechnology laboratory or manufacturing environment preferred.
  • Knowledge of GMP concepts and documentation practices.
  • Knowledge of Aseptic practices


PHYSICAL/MENTAL REQUIREMENTS

  • Work within a BSC
  • Ability to use handheld, manual and automated pipettes.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Sunday to Wednesday 2:00PM to 12:30AM (4-day week)


Work Location Assignment: On Premise

Relocation assistance may be available based on business needs and/or eligibility.

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