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 Laboratory team. The Quality Control (QC) Scientist is responsible for scheduling prioritization, workload distribution, and laboratory process improvement for API, in-process, final product or Incoming Material testing at the Rocky Mount site. This includes communicating priorities to the lab and following up with customers on testing status.

The QC Scientist assists with supervisor duties for atypical, OOS, questionable, and invalidated data occurrences and will cover data integrity responsibilities. The Scientist represents and/or leads the lab unit or the entire lab organization on high complexity projects and project teams both within and outside of Quality Control Operations. This role provides leadership and technical expertise to assist the laboratory with troubleshooting, investigations, computer validation and instrument qualifications.

The QC Scientist may be involved in second checking of data and will perform assays as needed. This role has the responsibility of serving as Management Designee and will have limited input into the OTE colleague performance assessment process. The QC Scientist may defend QO Laboratory Quality Systems during audits and inspections.

How You Will Achieve It

• Initiates and documents laboratory investigations for human error, procedural deviations, atypical, OOS, questionable, and invalidated data occurrences.

• Assures adherence to data integrity initiatives.

• As a Subject Matter Expert (SME), represents the lab unit or the entire lab organization on high complexity projects and project teams both within and outside of QC.

• Leads medium or high complexity project teams within QC tasked with improving laboratory or other quality systems.

• Assists QC Lab leadership in determining scheduling priorities and workload distribution to ensure customer needs are met.

• Performs data quality inspection through Quality audits and 2nd check of laboratory data packets.

• Performs analytical assays during times of need.

• Demonstrates a technical mastery of one or more techniques in fields such as: wet chemistry, chromatography, physical chemistry, spectroscopy, visual inspection or dimensional measurements as well as a complete knowledge of laboratory operations including both technical and compliance aspects.

• Applies knowledge of advanced techniques and procedures with recommendations and implementation of new or modified procedures or instrumentation for improved lab efficiency.

• Trains others in the theory and practice of both laboratory techniques and quality systems including investigations, instrument qualifications, etc.

• Independently writes SOPs, technical reports, project plans, instrument qualifications, etc.

• Serves as management designee and will have limited input into the OTE colleague performance assessment process.

Qualifications

Must-Have

• Applicant must have high school diploma (or equivalent) with six years of relevant experience.

• OR an associate degree with four years of experience.

• OR a bachelor’s degree with 0 years of experience.

• Prior Data Review experience

• Prior experience in a Quality Control Laboratory environment

• Knowledge of cGMPs and regulations outside of the US.  

• Must be familiar with operation and maintenance of routine Lab equipment, including various optical comparators, smart scope, calipers, micrometers, etc.

• Good communication, organization and computer skills are required.

• Strong written and verbal communication skills.

• High level of organizational skills and independence.

Nice-to-Have

• LIR / RAAC Author or equivalent QTS, eQMS investigation experience

• Trained to execute and record check multiple Chemistry/Incoming Material laboratory technologies

• Document Change Management experience, SOP Revision Management

• Project Management experience

PHYSICAL/MENTAL REQUIREMENTS

Stand up for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective clothing (lab coat, safety glasses, gloves, face shield/goggles, apron), repetitive use of upper extremities.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

There are no out of the ordinary travel or shift requirements associated with the position.   Individual will be expected to work nonstandard schedule as needed to support the business objectives.

Relocation support available: YES
Work Location Assignment: On Premise

Last date to apply: June 8th, 2023

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