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Quality Assurance Director / Boston MA / 80 – 115k

Vacancy – Director of Quality Assurance

Company - Confidential

Location – Boston, MA (ZIP 02135)

Salary - $80,000 to $115,000 per year (+bonus & profit share)

Excellent benefits, health, dental, vision, 401k

Panther Recruitment is searching for is looking for a person who is ready to make the transition from managing quality assurance activities to playing an instrumental role in developing a premier quality assurance unit. The applicant must be interested in working in a high energy environment bringing together all departments to achieve goals and elevated quality levels.

 

Our client is a small, privately held, highly successful company in the medical / pharmaceutical industry, located in Cambridge, MA. The company has 35 employees, and is a closely knit, professional team.

The flowing duties will be part of the role:

In this role you will be responsible for the overall management of the quality activities of the company and report directly to the CEO. Responsibilities include but are not limited to:

 

  • Overseeing compliance for the CLIA/CAP laboratory

  • Maintaining knowledge in GLP/GMP/CAP/ CLIA regulations.

  • Identifying the quality systems and procedures required to meet all regulatory requirements and quality levels set by the Company.

  • Maintaining Master Schedule Logbook of all studies conducted at the testing facility.

  • Reviewing the GLP study protocol, for accuracy and completeness, before being sent to the Sponsor, as an authorized Company representative.

  • Maintaining copies of all protocols associated with each study.

  • Inspecting each study at intervals (internal study audit) to assure the integrity of the study

  • Bringing to the attention of the Study Director and Management, any findings or problems found during the inspection which may impact the study.

  • Assuring that deviation from protocols or SOPs, and the impact on the study, are documented, and properly authorized.

  • Assuring implementation and documentation of the appropriate corrective action, to resolve any problems or issues.

  • Submitting written audit reports on each study audit, after the audit close-out date, to the Study Director and management, noting any problems and the corrective action taken

  • Assuring that Quality Assurance standard operating procedures (SOPs) are in place for the performance of audits, corrective action, follow-up and closure, indexing, retention and archiving.

  • Evaluating subcontractors to assure compliance to the applicable regulations.

  • Reviewing and providing complete analytical method documentation including notebooks, development reports and method validation protocols and reports.

 

Position requires a BS in Biomedical Sciences (Chemistry, Molecular Biology, Biology, and Biochemistry) plus a minimum of 10 plus years of experience supporting a laboratory quality system performing highly complex assays. Excellent computer skills and experience with Access, Excel and Word a must.

 

If you think this role may be a fit for you, please contact Mark Spencer, Manager, Panther Recruitment – mark@pantherrecruitment.com, and we will be happy to discuss the opportunity with you.

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