Sr. Quality Assurance Scientist, QA – Analytical S

2/18/21

High Point, NC 27260

1169

FullTimeRegular

Summary

Our client is seeking a highly motivated, energetic, results-oriented individual to join our QA team of dedicated professionals focused on customer service and quality. We are currently accepting resumes for the position of Senior Quality Assurance Scientist – Analytical Support.

Purpose

The Sr. QA Scientist is an advanced level position with hands-on QA experience in a pharmaceutical environment. Working independently and under minimum supervision, the individual will be working primarily to support Quality Assurance and Quality Control. The Sr. QA Scientist, will assure products are manufactured and tested are in compliance with internal, regulatory and industry standards, meets business needs and optimizes cost in the quality organization of the manufacturing facility.


Responsibilities

  • Review and may approve documents such as standard operating procedures, test methods, specifications, stability protocols and reports.
  • Perform approval process for analytical procedures.
  • Perform approval process for analytical protocols / reports.
  • Perform a wide variety of quality assurance activities to ensure compliance with internal procedures, applicable US regulatory requirements, and customer requirements for drug substances under clinical development
  • Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, lab investigations, CAPAs and change control; review and may approve quality system documents related to manufactured products
  • Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines.
  • Assist with hosting and responding to client audits
  • Conduct onsite audit of contract laboratories
  • Assist with developing and maintaining company’s quality system
  • Support continuous improvement of quality systems; author new, revise existing and may review department procedures and/or forms
  • Support quality systems, as needed (e.g., issue and track closure to change controls, deviations, quality investigations, CAPAs)
  • Assist with inspection preparation and inspection strategy room for regulatory agency inspection or third party audits
  • Other duties as assigned and / or developed by Senior Director, Quality Assurance

Minimum Requirements

  • Bachelors of Science Desired: Bachelors of Science in Biology, Microbiology, Chemistry, Biochemistry, Pharmacy, Engineering, or related field.
  • 10 + Years’ experience in a GMP regulated environment, preferably in a QC and/or analytical laboratory
  • 3 + Years’ experience in Quality Assurance
  • Works independently with minimum supervision to accomplish goals
  • Good working knowledge and understanding of 21 CFR Parts 210, 211, and ICH Q7
  • Relies on extensive experience and judgment to resolve simple to moderately complex issues
  • Excellent verbal and written communication skills

Other Experience/Skills:

  • Root-Cause Investigation and Statistical Analysis Experience.
  • Regulatory compliance and/or previous regulatory audit experience.
  • Experience conducting onsite audits of contract laboratories
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