Senior Quality Assurance Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
  3. United States
Burlington, USA
Posting date: 29 May 2020

Proclinical is currently recruiting for a Senior Quality Assurance Specialist with a pharmaceutical company located in Burlington, MA.

Job Responsibilities:

  • Responsible for working cross-functionally with Manufacturing, Process Engineering, Facilities, Inspection, and Project Management on Quality Assurance (QA) activities such as the following:
      • Quality oversight for validation (review of IQ, OQ & PQ packages)
      • Compliance to Validation Master Plan requirements
      • Manufacturing Quality Oversight (batch record review, quality approver for manufacturing deviations)
      • Quality Impact Assessment for Manufacturing and validation related Deviations, Change Controls, and CAPA
      • Driving Quality Metrics
      • Product Disposition
  • Educate and train manufacturing/process engineering personnel to execute production in full accordance with cGMP's and quality system to ensure real-time compliance
  • Represent quality assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and appropriately documented

Skills and Requirements:

  • Bachelor's Degree in a life science field; an alternate field of study may be considered in combination with significant Aseptic Manufacturing industry experience
  • 6+ years of experience in Quality Assurance supporting manufacturing in Pharmaceutical, Biotechnology or Medical Device industry
  • Previous experience supporting on-the-floor activities for a production facility
  • Strong facilitation and problem-solving skills
  • Excellent written and verbal communication and presentation skills. Comfortable presenting information to management & peers
  • Comfortable working independently in combination with individuals in other departments across the organization
  • Strong working knowledge of PDA, FDA (21 CFR Part 210, 211, 600), EMA (Eudralex Volume 4), ICH, ISPE, USP/EP monographs, and GAMP 5 guidance
  • Proficient in Microsoft Office and TrackWise

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.