Quality Assurance Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
  3. United States
Bloomington, USA
Posting date: 21 Sep 2020

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

Job Responsibilities:

  • Support the effective and compliant execution of tech transfer activities and development of necessary quality systems at the manufacturing sites and associated off-site storage locations.
  • Support site qualification activities and development of quality agreements in accordance with company standards.
  • Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch records to ensure company products/processes comply with cGMP requirements.
  • Support regulatory submission activities, and lead inspection readiness activities in partnership with external manufacturing site and our client to support global health authority approvals.
  • Following successful tech transfer, support quality oversight for day-to-day production activities, including deviation and CAPA management, escalation of critical issues, and change control.
  • Monitor external manufacturing quality performance and proactively identify risks and mitigation plans through benchmarking and knowledge sharing.
  • Influence and build relationship with internal and external partners to continuously enhance quality culture and business excellence.
  • Interface with other functions (Operations, Planning, Technical Operations, Local Affiliates etc.) to meet patient supply requirements
  • Apply cGMP regulations and other FDA and international requirements to all aspects of the position.
  • Ability to work from home 20% depending on activity needs

Skills and Requirements:

  • Bachelor's Degree with a concentration in science, or an equivalent technical discipline
  • Minimum of 5 years working in an FDA regulated environment
  • Experience in pharmaceutical aseptic manufacturing operations and quality assurance
  • Detailed knowledge of cGMPs related to pharmaceutical production
  • Strong interpersonal and written/oral communication skills
  • Ability to quickly process complex information and make critical decisions with limited information required
  • Validation quality assurance experience is required

If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.

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.