Quality Manager for PerkinElmer Genetics
General Summary: PerkinElmer Genetics, a state-of-the-art newborn screening laboratory, provides one of the world's most comprehensive programs for detecting clinically significant inherited disorders. The Quality Assurance Manager performs duties to ensure the quality management system at PerkinElmer Genetics is in compliance with requirements identified by Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), as well as any other applicable laws, statutes, laws, regulations and individual contract requirements. This position may require regular travel to a Branford, Connecticut location.
- Develop and participate in a Vendor Management Program; including auditing critical vendors where needed
- Develop and maintain a complaint process program for client feedback and complaint investigation
- Assist in the development, review and approval of verification plans for the lab equipment and assays
- Writing report summaries and data review for validation and verification activities
- Assist in the maintenance of the document control system by publishing and processing controlled documents through the electronicdocument management system
- Assist the Sr. Manager of Quality in the auditing program (internal, client specific, and regulatory)
- Data gathering and review for metrics
- Gap analysis of regulatory requirements versus current practice
- Quality Event Reporting and CAPA
Job Requirements :
Education: Minimum Associates degree in scientific discipline.
Experience: At least 5 years of experience in a Quality Assurance role in a clinical laboratory setting. Document control, change management, and report writing required. Must have working knowledge of Microsoft Applications (Word, Excel, Office, and PowerPoint). Knowledge of CAP and CLIA regulations is required.
Working Conditions: The primary working condition associated with this position is working independently in the office environment. While completing Quality Assurance / Validation activities, it is frequently required to work cross-functionally; and/or to enter and work in the Laboratory, in which the conditions may be variable from day to day. Travel may be required up to 20%.
Mental and Physical Demands: Requires the ability to lift and carry up to 25 pounds, sit and/or stand for prolonged periods of time and effectively manage conflict and emotional or stressful situations.
Potential Job and Task Hazards: Potential hazards associated with blood products.
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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