Associate, Investigator/Documentation Specialist

ROLE SUMMARY

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.

ROLE RESPONSIBILITIES

• 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

PREFERRED QUALIFICATIONS

• 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

PHYSICAL/MENTAL REQUIREMENTS

• 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

ADDITIONAL INFORMATION

• Last Date to Apply: December 10, 2020
• Eligible for Employee Referral Bonus: Yes
• #LI-PFE

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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.

Research and Development