QA Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United States
Waltham, USA
Posting date: 22 Apr 2021

Proclinical is currently recruiting for a QA Specialist with a pharmaceutical company located in Waltham, MA.

Job Responsibilities:

  • Support product batch disposition by conducting review of executed batch record; disposition documentation package preparation; review of deviations.
  • Accurately update/maintain batch trackers; lot genealogies; compliance trackers such as Quality alerts; Quality bulletin; KPIs, etc.
  • Manage/upload product disposition documentation in the controlled documentation system ensuring proper archival.
  • Clearly communicate issues as applicable to CMOs and Quality management in a timely basis
  • Review and approve documentation related to production and / or packaging operations as assigned.
  • As appropriate attend project meetings.

Skills and Requirements:

  • Minimum bachelor's degree in science (Biology; Chemistry; Biotechnology; Pharmaceutical Science)
  • Minimum of 8+ years of experience in pharmaceutical industry with at least 3-5 years in Quality (no rookies)
  • Experience and working knowledge on Small molecules chemistry, tablets and capsules.
  • Experience building relationships and working with CMOs
  • Working knowledge ICH/EMA/FDA regulations
  • Competency in MS Office, Adobe Acrobat, Veeva, Trackwise

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

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.