QA Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. United States
Rochester, USA
Posting date: 17 Jan 2020

Proclinical is currently recruiting for a QA Specialist for a laboratory located in Rochester, NY. Successful candidate will promote and support a culture of audit readiness.

Job Responsibilities:

  • Independently perform a wide range of activities to support the Quality Assurance department by participating in the processes required to achieve & maintain the required accrediting agency/standards & regulatory requirements for the organization.
  • Support the promotion and compliance with regulations, guidelines, and Standard Operating Procedures within the organization.
  • Serve as a resource promoting the development and understanding of the key elements related to Quality Management Systems & regulatory compliance requirements including training opportunities to staff at an organizational level
  • Maintain current awareness of all required standards, laws & guidelines
  • Provide input to the development of Quality Assurance Standard Operating Procedures & processes, the Quality Manual and other organizational Standard Operating Procedures & processes where required
  • Prepare for, carrying out, report and follow up of Quality Assurance required audits - including internal, 3rd party and vendor audits
  • Recommend systems for audit, write audit plans, coordinate scheduling & closure of internal audits
  • Participate in review of root cause analysis, corrective action & preventive action plans for internal, 3rd party & vendor audits
  • Responsible for ensuring assigned internal audit & vendor audits are completed as scheduled and reporting associated metrics to Quality Assurance management. Monitor the compliance of all departments via routine audits to ensure adherence with internal Standard Operating Procedures & external regulations
  • Support the processes in place to ensure customer complaints are appropriately raised and handled
  • Support the processes in place to ensure internally identified Quality Issues are appropriately raised and handled
  • Provide oversight & participate in review root cause analysis, corrective action & preventive action plans for Quality Issues & customer complaints
  • Provide oversight to the documentation, reporting, effectiveness checks & closure of compliance issues (audits, Quality Issues & customer complaints)
  • Participate in Lean/Six Sigma, process improvements

Skills and Requirements:

  • Bachelor's degree or at least 10 years of Quality Assurance experience in the healthcare industry required.
  • 3 years of quality assurance experience required; experience in a laboratory, pharmaceutical or Clinical Research Organization (CRO) preferred.
  • Knowledge of and demonstrated experience in Good Clinical Practice (GCP), ISO15189, NEQAS, CAP, CLIA strongly preferred.

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 Max Robinson at (+1) 646-630-9650 or upload your resume on our website -

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.

Proclinical Staffing is an equal opportunity employer.