Pfizer Associate, Investigator/Documentation Specialist in Andover, Massachusetts
Andover Liquid Dosage Manufacturing (AN-LDM) Investigator/Documentation Specialist is responsible for writing investigations and implement Corrective Action/Preventive Action (CAPAs) in the QTS system for AN-LDM facility. The candidate will also assist with managing the lifecycle of all relevant GMP documentation (SOPs, logbooks, etc.) and assist with batch record creation, revision, and issuance as required.
Initiate and document incidents in the QTS system according to current procedures
Interact directly with manufacturing to investigate all (ER and QAR) to identify root cause
Propose corrective and preventive measures that respond to the underlying cause of the investigation
Assist with writing, revising, and issuing drug product batch records for use by manufacturing technicians
Ensure that each investigation is complete and follows the process defined in internal procedures and the type M1 methodology for problem solving
Promptly escalate any unforeseen situation or irregularity found in the investigation process
Assist with ordering, receiving, maintaining and archiving logbooks and other GMP documentation
Revise/improve clarity of standard operating procedures by incorporating Pfizer Human Performance (PHP) principles.
Qualifications BASIC QUALIFICATIONS
BS degree with 1 to 2 years of experience in a GMP document management /records management position required.
Strong attention to detail, along with excellent communication and collaboration skills
5+ years in regulated pharmaceutical industry
BS in a technical or science field
Strong attention to detail and excellent written and verbal communication skills, including technical writing skills
Requires thorough knowledge of cGMP and an ability to handle multiple projects
Proficient in Microsoft Office (Word, Excel)
Working knowledge of Trackwise preferred but not required
Collaborative skills and effective partnering skills in complex working environments
Ability to work in a dynamic multi-discipline organizational model
Ability to work independently and multi-task in a fast, priority environment
Ability to understand technical documentation relevant to tech transfer
Ability to lift up to 50 pounds
Ability to gown to enter non-aseptic and aseptic areas of the LDM
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Minimal travel required
Last Date to Apply: December 10, 2020
Eligible for Employee Referral Bonus: Yes
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