Biotheranostics, a Hologic Company is seeking a Senior Quality Assurance Specialist to join the Quality Team within the company’s Diagnostic Solutions division. 

Responsible for managing the development, implementation and maintenance of Biotheranostics’ Quality Management Systems in compliance with applicable State, Federal and accrediting agency regulations and requirements including California, CLIA, CAP and NYSDOH. These systems and processes include but are not limited to Test Method Validation, Change Control, Internal Audit, Design Control, Complaints Management and Investigation. Key areas of focus include processes for managing and investigating and resolving deviations, non-conformances and complaints including Corrective and Preventive Actions (CAPA). This position will interface with cross-functional departments to facilitate adherence to system requirements and resolution of events. Candidate is expected to effectively lead and mentor a team.

Responsibilities:

• Defines, implements, communicates and maintains policies and procedures regarding Quality Systems in compliance with CLIA regulations.
• Manages IR/CAPA program and ensures deviations, non-conformances, complaints and other operational quality issues are investigated, resolved and effective to support compliance with requirements and to reduce risks to patients.
• Provides quality consultation and record review for validation/design review activities.
• Manages Change and Transfer Program to ensure changes in the laboratory are properly documented, evaluated and controlled.
• Leads cross-functional teams to develop and to improve systems to increase efficiency of quality processes.
• Assists Quality Management in providing regulatory and quality consultation to the laboratory and executive management.
• Participates in third party regulatory and supplier audits and inspections.
• Participates in and supports internal audit program.
• Promotes a culture of quality throughout the organization through training, communication and quality awareness.
• Develop, analyze, trend, maintain and report quality metrics.
• Conducts and/or supports Management Reviews.
• Provides site training on quality processes.
• Provides quality consultation and support to CRU/R&D.
• Provides quality review of records for Medical, Legal, Regulatory (MLR) Review.
• Proactively identify and help implement improvement plans and executes improvement projects
• Other duties as assigned. 

Minimum Education/Experience Requirements:
• BA or BS degree required in life sciences, physical sciences, engineering or other applicable technical field.
• Understanding of LDTs in CAP accredited and CLIA certified laboratory.
• A minimum of 7-9 years of Quality experience for the design and production of LDT products in a CLIA laboratory and/or IVD products within an FDA regulated cGMP manufacturing facility.
• Quality Control and Process Transfer experience is a plus
• CAPA experience is highly desired
• Experience in medical device quality system regulations is preferred. 
• ASQ Certification or equivalent experience.
• Advanced knowledge and experience investigating and resolving nonconforming events, deviations, and complaints.
• Strong aptitude for troubleshooting issues and partnering with others through resolution,
• Ability to lead project teams.
• Strong commitment to detail and error-free performance with ability to multi-task.
• Organizational skills, attention to detail and ability to prioritize in a fast-paced environment are essential. High proficiency in Microsoft suite.
• Self-starter and able to work with minimum supervision.
• Excellent verbal and written communication skills and presentation abilities.
• Excellent time management skills and ability to identify when to be flexible with specific procedures while compliant with CLIA, CAP, NYSDOH and the QSRs. 

The annualized base salary range for this role is $104,800 to $163,900 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency And Third Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic’s employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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