Quality Assurance Specialist

Access Biologicals LLC
Vista, CA
Sep 29, 2017
Jobs Outside Higher Education
Other Jobs Outside Higher Education
Institution Type
Outside Academe

Job Description

JOB TITLE: Quality Assurance Specialist


Perform activities of significant variety and complexity to ensure compliance with applicable regulatory requirements and corporate quality policies. These activities include management of vendor qualification, assisting in client audits and regulatory inspections, and management of complaints, CAPAs and NCMRs. Additional duties include performing quality and compliance training, reviewing documents and data, and facilitating quality system improvements, in addition to other functions in support of our quality objectives. This position is full-time, Monday-Friday, 8am-5pm. Compensation is commensurate with experience. Benefits package, after 90-day probationary period, includes vacation and sick pay, full medical / dental / vision coverage and 401(k) with company match.

  • Lead or co-lead client audits and inspections and provide support during regulatory inspections
  • Perform external vendor and contract service provider audits, including scheduling, conducting opening and closing meetings, issuing audit reports and verifying CAPA plans are implemented
  • Assist in identifying medical device/ drug regulations for various geographies
  • Facilitate quality system improvement programs and initiatives
  • Review and approve GMP documents such as executed batch records, validation protocols and reports, SOPs, and change controls to ensure compliance
  • Assist in FDA and USDA regulatory submissions
  • Assist in management of risk assessments, complaints, CAPAs and NCMRs, perform trend analysis and maintain quality databases
  • May require up to 10% travel

  • Requires a High School degree with a minimum of 3-5 years related quality assurance experience
  • Experience working in the pharmaceutical and/or medical device or other highly regulated industry is required
  • Good knowledge of applicable regulations and guidance documents for human blood products and medical devices, including ISO 9001;2015, ISO 13485, FDA QSRs, European regulations, and USDA regulations for animal serum
  • Knowledge or experience in risk management
  • Experience with clean room operations is a plus
  • Excellent communication and technical writing skills
  • Excellent attention to detail, strong organizational skills with ability to execute assignments under minimal supervision
  • Computer literate with good working knowledge of Microsoft products (ERP experience is an added advantage)

Company Description
Access Biologicals LLC is an industry leader in the collection and manufacturing of an extensive portfolio of biological products. Combined with closed-loop material sourcing, we are able to provide critical support for various markets such as in-vitro diagnostic manufacturing, biopharmaceutical, cell culture and diagnostic research & development. Viral testing and donor examinations are performed in accordance with current State, CLIA and FDA regulations allowing us to deliver consistently high quality human blood products. Manufacturing capabilities include a variety of plasma and serum processing in fully auditable facilities with on-site monitored storage. Our high throughput laboratory provides customer-driven responsiveness to specifications and product requirements. Our cell culture division offers a variety of human and animal sera products, and is the only company to directly collect and process Human AB serum at FDA licensed facilities located within the US.

Vista, CA


Sun, 24 Sep 2017 09:48:49 PDT