What are the responsibilities and job description for the Quality Assurance Specialist, Product Release position at Hologic Careers?
Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.
The San Diego Campus is the center of our Diagnostics Solutions Division. With the focus on Molecular Diagnostics, most products produced are utilized onboard innovative and fully automated sample-to-result instrument systems. The consumables required for patient testing are integral to our business. The business growth projections and new product development projects provide unique opportunities to enable our Purpose, Passion, and Promise to empower global health advancements.
Our Quality Assurance department is looking for a Quality Assurance Specialist, Product Release and in this local role, you will be responsible for supporting and working within the Product Assurance Release team. Responsible for ensuring compliance with applicable domestic and international standards and regulations through audits and systematic maintenance of effective quality systems. Ensure that deadlines are met on time and within budget. Limited interface with other departments and business or marketing partners. Work independently with limited supervision and exercise judgment within the defined procedures and practices to determine appropriate actions.
Essential Duties and Responsibilities
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Performs batch record review of less complex documentation for finished products such as subassemblies, bulks, labeled reagents and kits.
- Performs approval and final release of less complex documentation for finished products such as subassemblies, bulks, labeled reagents and kits using the EDMS and ERP system.
- Conducts compliance audits of less complex documentation & data.
- Assists in internal and/or walk around audits.
- Serves as QA interface with limited responsibilities.
- Prepares data packages for external customers and regulation bodies.
- Performs compliance activities such as QA Holds, room releases, at-risk processing, etc.
- Assists in new employee training.
- Performs initial troubleshooting activities.
- Assists in maintenance & reporting of department metrics.
- Review and assess the appropriateness of document changes in accordance with internal procedures with oversight and guidance.
Qualifications
- Bachelor of Science degree with 0 - 2 years of related experience is preferred
- Basic knowledge of QSR & ISO requirements
The annualized base salary range for this role is $69,000 to $85,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.
Why Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
We offer a competitive salary and annual bonus scheme, and one of our Talent Partners would be happy to discuss this in more detail with you.
If you have the right skills and experience, apply today!
#LI-RF1 #Entry-level
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, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
