Job Description

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.

Role Summary

Quality Sample Management is looking for a highly motivated individual to support commercial manufacturing and QC testing labs by managing the receipt, delivery, and storage of release test, backup, retain, reference material, assay controls, and stability samples. Support and maintain the retain program as required by CFR regulations. Must be familiar with aliquoting of bulk samples in an aseptic manner (Bio-Safety Cabinet) including but not limited to; label generation/reconciliation, line clearance, product segregation, and quality review. Monitoring of environmental chambers is also critical to the storage of the above sample types. Additional responsibilities include creating/revising Standard Operating Procedures and serving as a point of contact for QC Sample Management projects. The candidate will work closely with cross functional groups within Pfizer, Andover MA to provide sample support. Participate as an SME during audits, including conducting tours of the QSM area during audits.

Role Responsibilities

* Perform all work in compliance with Current Good Manufacturing Practices (cGMPs), site, and regulatory requirements
* Manage the end-to-end lifecycle of Quality Control samples including release test samples for in-process, drug substance, drug substance intermediates, and drug product, as well as the reference standard and assay control programs
* Work with a cross functional team to define and implement an improved end-to-end process for all sampling activities including bulk sample sub-aliquoting for distribution to the QC laboratories
* Serve as Subject Matter Expert (SME) for all sample aliquot activities
* Serve as the primary backup for shipping and receiving of biological and temperature sensitive samples to contract laboratories.
* Serve as SME within area of responsibility during on-site inspections and audits
* Support investigations, Corrective Action/Preventative Action (CAPAs), and change controls
* Receipt, inspection, and handling of drug product samples from a CMO

Basic Qualifications

* High School Diploma or Equivalent with 5+ years of experience working in a cGMP environment OR Associate's degree or Bachelor's degree with 3-5+ years of experience working in a cGMP environment required.
* Established proficiency with all aspects of sample aliquoting including sample handling requirements, Bio-Safety Cabinet (BSC) operation and maintenance, label generation and reconciliation, sample labeling, line clearance, product segregation, and quality review.
* Proficient with shipping and receiving procedures and regulations.
* Competency with computers required.
* Must be detail oriented and be able to work under pressure to meet deadlines.
* Ability to work effectively in a collaborative team environment.
* Knowledge and experience of FedEx and World Courier processes and requirements.

Preferred Qualifications

* 49CFR and IATA certified.
* Experience with Labware LIMS.

Physical/Mental Requirements

* Excellent technical writing skills for documentation and investigations
* 50-75% of time standing
* Ability to move/lift up to 50 lbs with assistance
* Ability to work in a BSC environment

Non-Standard Work Schedule, Travel, or Environment Requirements

* Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required to support operations

Other Job Details:

* Last Date to Apply for Job: 11 JANUARY 2021

* Eligible for Employee Referral Bonus

* LI-PFE

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 providers 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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