Quality Assurance Supervisor

US$50000 - US$65000 per annum + DOE
  1. Permanent
  2. Good Pharmacovigilance Practice (GVP)
  3. United States
North Fort Myers, Florida
Posting date: 08 Mar 2019
QA.KD.22143_1552061150

ProClinical, in support of our client, are seeking an individual to fill the role of Quality Assurance Supervisor to join a growing plasma company based in North Fort Myers, FL. Reporting into the Regional Director of Operations, the successful candidate will be responsible for the overall quality program of a newly-opened donor center.

Responsibilities

  • Determine if quality activities and manufacturing records follow internal and external regulatory requirements; determine the need for corrective actions; ensure proper documentation and determine effectiveness of action.
  • Perform final QA review and release for all product shipments and associated documents to ensure shipment meets customer specifications.
  • Perform regular quality compliance audits of the center activities.
  • Provide direction and oversight of Quality staff to ensure required quality tasks are completed correctly.
  • Provide coaching and mentoring to Quality staff.
  • Prepare staff and co-host internal and external audits.
  • Collaborate with the Center Manager to complete all audit responses, ensuring that all audits are responded to and closed in required time frames.
  • Ensure that monthly Quality and Safety meetings discussing SOP changes and regulatory requirements are conducted, documented and minutes are communicated to all center staff.
  • Obtain certification as a Quality Trainer.
  • Responsible for training of center Quality Assurance staff.
  • Analyze tracking and trending data and determine appropriate actions to improve trending.

Skills And Qualifications

  • BA in an applicable field of study (or an equivalent combination of education and experience may be considered). ASQ certification is preferred.
  • 1+ year(s) of work experience in biologics industry (donor center preferred) and 1+ year(s) of quality assurance-related work experience.
  • Supervisory experience preferred.
  • Strong knowledge of/aptitude for Microsoft Office suite.
  • Strong written, verbal, and interpersonal communication skills.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kaye Dunleavy at (+1) 646-367-2646 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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