What are the responsibilities and job description for the Manager, Quality Assurance position at REVVITY?
About Us
Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world's greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our diverse team of 11,000 colleagues from around the globe are vital to our success and the reason we're able to push boundaries in pursuit of better human health.
Find your future at Revvity
General Summary: In this role, the Manager Quality Assurance for Revvity's Genomics, Pittsburgh, Pennsylvania, will provide support to the Laboratory Director, Site Manager, and all supervisors on all quality related matters. S/he will develop and implement training and education programs, to educate workers and management on quality processes, standards, and results. S/he will facilitate quality meetings with pertinent site management. A strong candidate for this position will be able to maintain good rapport and communication with leadership and team members while ensuring solid execution of all quality programs.
Duties and Responsibilities:
- Maintain Laboratory Services Quality Management System to ensure the systems are in alignment with the current requirements and operational processes.
- Oversee and maintain Corrective and Preventive Action (CAPA) Program and ensure all quality events are documented, investigated, assessed for impact, root cause and risk, and all associated actions are completed in a timely manner.
- Oversee and maintain the Vendor Management Program by performing periodic reviews of vendors and reference laboratories as well as critical vendor audits.
- Manage the Audit Program by conducting internal process audits; Hosting inspections and cross-site audits.
- Manage the Customer Complaint Program to ensure consistency of complaint intake, investigations and customer follow-up.
- Manage and maintain the Electronic Document Control (EDC) system and records management. Provide guidance over all document types and formats as well as conduct EDC training and troubleshooting.
- Independently assess the need for, handle and implement Quality Improvement initiatives
- Assist in the development and review of test method validation plans and the quality review of reports to support optimization and new product offerings for biochemistry and molecular genetics testing.
- Conduct periodic compliance training and verify personnel training records are maintained, current and inspection ready.
- Maintain, communicate and compile quality metrics and key quality indicators for quarterly management review meetings.
- Collaborate and facilitate effective communication among various Laboratory management.
- Familiarity with operation of laboratory instruments and applicable computer software.
- Other duties as assigned
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities of this job at any time.
Basic Qualifications:
- Bachelor of Science degree
- 4- 7 years of experience in quality management or clinical laboratory activities.
- 1-2 years of experience with laboratory developed tests.
- 1 year of experience leading clinical regulatory audits (e.g. CLIA, College of American Pathologists, New York State).
Preferred Qualifications:
- Start-up laboratory experience strongly preferred
- Experience with industry clients and related standards (e.g. GCP, GLP, ISO 9001, ISO 15189)
- Previous experience of working in quality in clinical genetic testing laboratory as a Technologist or Quality Engineer
- Partner and work collaboratively with laboratory operations staff
- Proven track record of delivering continual positive process improvement in systems and process.
- Proven leadership and excellent organization and communication skills
- A good balance of negotiating and influencing skills.
- Excellent presentation skills
- Be detail oriented, organized, with excellent verbal and written communication skills.
- Able to work effectively and able to deliver on tight datelines
- Comfortable working in a fast-paced environment
Working Conditions:
- Clinical and research lab environment; exposure to blood borne pathogens; must wear personal protective equipment including lab coat, gloves and completely closed footwear.
- Employee may be requested to work shifts other than daylight depending on the needs of the laboratory.
- Weekend rotation may be required.
- Travel is not required.
Physical Requirements:
- While performing the duties of this job, the employee is regularly required to sit, stand, use a keyboard, type, and occasionally stand and move to other parts of the lab
- Must have manual dexterity to use lab equipment
- Reach above/below the shoulder, bend at the knees and waist
- Able to lift boxes up to 25 pounds
What do we offer?
We provide competitive and comprehensive benefits to our employees.Below are some highlights of our benefits:
* Medical, Dental, and Vision Insurance Options
* Life and Disability Insurance
* Paid Time-Off
* Parental Benefits
* 401k with Company Match
* Employee Stock Purchase Plan
Learn more about Revvity's benefits by visiting our page.
*For benefit-eligible roles only. Part-time and temporary roles may not be eligible for all benefits listed. Please reach out to your recruiter for more information.
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Revvity 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. Revvity is committed to a culturally diverse workforce.
