Quality Assurance Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP)
  3. United States
Philadelphia, USA
Posting date: 21 Jan 2021

Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in Philadelphia, PA.

Job Responsibilities:

  • Review executed API, drug product and packaging batch records
  • Review deviations/investigations related to API and drug product manufacturing as well as packaging
  • Assist with disposition of clinical products in multiple phases of development
  • Review change control documentation associated with API
  • Assist with reviewing API manufacturing validation documentation
  • Assist with other QA duties such as development of the Quality Management System

Skills and Requirements:

  • S. degree in life sciences, chemistry or equivalent and 5+ years GMP quality experience in a virtual Pharmaceutical/Biotech setting
  • Experience with small molecule and solid oral dosage forms required
  • Experience in early phase development transitioning to registration and commercial
  • Working knowledge of ICH quality guidance, EU and FDA drug manufacturing regulations
  • Flexibility in handling workflow in a multi-tasking environment
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments internal and external to the company
  • Ability to effectively prioritize and manage multiple projects and tasks
  • Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions
  • At home in a results-driven, highly accountable environment where you can make a clear impact
  • A team player, who listens effectively and invites response and discussion
  • A collaborator who communicates in an open, clear, complete, timely and consistent manner

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.