Quality Assurance Manager

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP)
  3. United States
South Plainfield, USA
Posting date: 24 Mar 2021

Proclinical is currently recruiting for A Quality Assurance Manager for a leading biotechnology company located in South Plainfield, NJ. As the QA Manger, you will plan, direct and coordinate the efforts of Quality Assurance (QA) team towards maintaining an effective quality system.

Job Responsibilities:

  • Manages, maintains and improves the QA system to meet the regulatory standards needed by business units (ex. CLIA, CMS, HCS, DOH, etc.).
  • Oversees the review, update and maintenance of all SOP's and other QA documents.
  • Performs regular facility audit to ensure compliance to our quality system and governing regulatory body requirements.
  • Executes and upholds all clinical and state license.
  • Communicate any critical compliance risks to senior management.
  • Ensure regulatory rules are communicated through corporate policies and procedures.
  • Assume a lead role for the preparation, conduct, and responses to regulatory agency.
  • Responsible for the coordination of all laboratory activities to ensure compliance with the laboratory and corporate Quality Systems.
  • Assist in the development, notification and implementation of Quality Control Systems.
  • Mange all Clinical employee personnel files.
  • Assist in the development of training and competency of all clinical employees.
  • Monitoring compliance with standards established by regulatory and accrediting bodies such as NJ Clinical Laboratory Improvement Amendments and the Centers for Medicare & Medicaid Services.
  • Established, Maintains and Manages an instrumentation inventory to ensure all CLIA standards are met.
  • Assisting with the preparation, coordination, and management of regulatory agency inspections.

Skills and Requirements:

  • BA/BS, preferably in a scientific discipline or life sciences.
  • 3-5 years of relevant experience in a CLIA or CAP regulated environment preferred.
  • Knowledge of a high complexity clinical testing environment.
  • Must possess the technical and administrative abilities required to carry out routine audits with minimal supervision and to play a supporting role in more complex audits.
  • Must possess excellent communication and writing skills, patience, professionalism and ability to effectively interact with staff and management alike.
  • Ability to verbally communicate effectively with team members and multiple departments.

If you are having difficulty in applying or if you have any questions, please contact Jacqueline Zafrani at (+1) 213-893-4997 or j.zafrani@proclinical.com.

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.