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Qc Incoming Material Scientist

Company

Pfizer

Address , Rocky Mount, Nc
Employment type FULL_TIME
Salary
Expires 2023-07-27
Posted at 11 months ago
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.
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
  • Performs data quality inspection through Quality audits and 2nd check of laboratory data packets.
  • Leads medium or high complexity project teams within QC tasked with improving laboratory or other quality systems.
  • Trains others in the theory and practice of both laboratory techniques and quality systems including investigations, instrument qualifications, etc.
  • Serves as management designee and will have limited input into the OTE colleague performance assessment process.
  • Performs analytical assays during times of need.
  • Independently writes SOPs, technical reports, project plans, instrument qualifications, etc.
  • Applies knowledge of advanced techniques and procedures with recommendations and implementation of new or modified procedures or instrumentation for improved lab efficiency.
  • Assists QC Lab leadership in determining scheduling priorities and workload distribution to ensure customer needs are met.
  • Assures adherence to data integrity initiatives.
  • Initiates and documents laboratory investigations for human error, procedural deviations, atypical, OOS, questionable, and invalidated data occurrences.
  • 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.
  • 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.
Qualifications
Must-Have
  • Applicant must have high school diploma (or equivalent) with six years of relevant experience.
  • Strong written and verbal communication skills.
  • OR a bachelor’s degree with 0 years of experience.
  • Knowledge of cGMPs and regulations outside of the US.
  • High level of organizational skills and independence.
  • Prior Data Review experience
  • OR an associate degree with four years of experience.
  • Prior experience in a Quality Control Laboratory environment
  • Good communication, organization and computer skills are required.
  • Must be familiar with operation and maintenance of routine Lab equipment, including various optical comparators, smart scope, calipers, micrometers, etc.
Nice-to-Have
  • LIR / RAAC Author or equivalent QTS, eQMS investigation experience
  • Project Management experience
  • Document Change Management experience, SOP Revision Management
  • Trained to execute and record check multiple Chemistry/Incoming Material laboratory technologies

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.
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
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