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Sr. QA Specialist

  • Job type: Permanent
  • Location: Greensboro, North Carolina
  • Salary: Negotiable
  • Job reference: 182724/003_1531502472
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 13/07/2018

Senior QA Specialist

  • Sr. QA Specialist

  • North Carolina

An innovative life sciences company with a patient-focused approach is seeking a Sr. QA Specialist to join their growing team! With over 35 years of active pharmaceutical ingredient (API) development and manufacturing expertise, a growing team of more than 1,200 experts and a strong presence in the USA and Europe, we are tried and trusted across branded and generic API markets.

The Sr. QA Specialist will have the following responsibilities:

Working independently and under minimal supervision, the Sr. QA Specialist will assure products are manufactured in compliance with internal, regulatory, and industry standards, meets business needs and optimizes cost in the quality organization of the manufacturing facility.

  • Review and may approve documents such as SOP's, manufacturing batch records, packaging and labeling records, test methods, specifications, stability protocols and reports

  • Review executed production batch records and associated documentation including any deviation and investigation reports related to lot release

  • Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, CAPAs and change control; review and may approve quality system documents related to manufactured products

  • Perform product complaints investigations

  • Assist with hosting and responding to client audits

  • Assist with developing and maintaining company's quality system

  • Support quality systems, as needed (e.g., issue and track closure to change controls, deviations, quality investigations, CAPAs)

  • In the absence of the Director, Quality Assurance provide guidance to the QA department.

  • Other duties as assigned and / or developed by Director, Quality Assurance

The ideal candidate will have the following skill set:

  • 10 + years of QA experience, with a minimum of 3 years supporting GMP manufacturing within the pharmaceutical industry

  • Minimum of 5 years handling quality system investigations, CAPA, change control, etc.

  • Good working knowledge and understanding of 21 CFR Parts 210,211 and ICH Q7

  • Bachelors degree in a life science related field required (advanced degree preferred)

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