QA Compliance Specialist

Portsmouth, NH

Posted: 05/17/2019 Job Number: JN -052019-10772
QA Compliance Specialist IV

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Title: QA Compliance Specialist IV
Location: Portsmouth, NH
Industry: Biopharmaceutical, Biologicals
Hours: 1st Shift Monday-Friday, 8am-5pm
Salary: $80,000-$90,000k (depending on experience), plus relocation assistance for right candidate
Employment Type: Direct hire

This is an advanced level Quality Assurance Specialist position that is responsible for planning and executing Internal Audits, and supporting preparation and execution of Pre Approval/Regulatory Inspections, customer audits, Global compliance audits.
  • Act as Lead Auditor or Co-Auditor in the planning and performance of assigned internal audits. As part of audit planning, review recent trends and areas of concern, prepare audit checklists and the audit agenda for FDA or other regulated entities.
  • As Lead Auditor, lead opening and closing meetings and communicate concerns to the departments in scope. Supervise auditors performing Lead Auditor tasks for training and qualification purposes.
  • Provide input to and/or write, issue, and disseminate the audit report. The Specialist can identify a compliance issue, and will have an understanding of GMP implications.
  • Review, follow up on, and approve audit responses. Escalate issues to supervisor when needed.
  • Initiate, track and close internal audit CAPA. The Specialist will work on complex CAPA records.
  • Author and/or contribute to the writing of the annual internal audit report and annual internal audit plan, as assigned.
  • Lead projects; define project plan, scope, and deliverables, as assigned.
  • Develop training materials for department and site personnel, as assigned.
  • Mentor and train other QA Specialists in all aspects of the role. Assume supervisor role in absence of supervisor.
  • Adherence to cGMPs is required at all times during the manufacture of APIs.
  • BS Degree Preferred area of study: Engineering, Regulatory, general science
  • One must have biologics experience. Experience working within a CMO environment is highly recommended.
  • Advanced years in cGMP QA (Intermediate to Advanced years in cGMP QA with ASQ certification)
  • Proven ability to communicate effectively, written and spoken
  • Leader and one will responsible to interact with FDA and other regulated entities
  • Licenses or Certifications -ASQ Certification preferred
  • Knowledge- Direct exposure to Regulatory Inspections, general inspection/audit expectations, in depth knowledge of company procedures and areas of concern. In depth knowledge of cGMP and current trends.
  • Skills - Written and verbal communication, ability to communicate QA and site expectations
Search words: QA, quality assurance, biologics, CMO, ASQ, investigations, CAPA, FDA, regulatory, compliance, audits, CAPA, manufacturing
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