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Operations Test Specialist 1-2

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Manufacturing Operations
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At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health
 
What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.
 
None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.
 
While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind.
 
Job Summary
The Test Specialist 2 candidate will be responsible for managing the team test schedule and delivering timely results using cGMP practices. The candidate will provide management support with team development, maintaining laboratory instruments, equipment and processes and supporting continuous improvement programs. The candidate will provide leadership on the team with technical issues, leading laboratory investigations, monitoring trend dashboards. 
 
Duties & Responsibilities:
  • Generate and manage test schedules in a dynamic manufacturing environment.
  • Support team’s technical development and quality training program.
  • Generate root cause analysis reports for laboratory investigations. Generate sound retest designs for invalid and out of spec results.
  • Support investigational testing for NCE product failures or out of trend results.
  • Generate high quality test procedures and SOPs to support New Product Introduction.
  • Lead document change control activities in Agile.
  • Work with the LIMS team to ensure alignment between Test Procedures and LIMS methods. 
  • Develop and manage metrics to ensure business excellence.
  • Collaborate with outside departments
  • Lead continuous improvement projects.
Qualifications:
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the basic knowledge, skills, and/or abilities required.
  • Experience with team management and development
  • Some lead experience a plus
  • Good understanding of FDA cGMP and ISO 13485
  • Good understanding of nucleic acid amplification technologies.
  • Good understanding of root cause analysis methods
  • Ability to troubleshoot and solve technical issues
  • Experience with ERP systems, EDMS systems, LIMS systems
  • Ability to present data to medium to large groups both internally and externally
  • Experience working in a timeline driven setting.
  • Sound technical writing
  • Ability to work in and/or lead cross-functional improvement teams
 
Education:
BS degree required
 
Experience:
6 years related experience in testing in a cGMP regulated lab.
 
 
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.
 

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