Operations Test Specialist 1 - Stability

Hologic San Diego , CA 92140

Posted 1 week ago

Our PURPOSE-to enable healthier lives everywhere, every day-is driven by a PASSION to become global champions for women's health. We succeed by fulfilling our PROMISE to bring The Science of Sure to life through product quality, clinical differentiation, customer relationships and our team's talent and engagement.

Our Purpose is simple: to enable healthier lives everywhere, every day. Toward this end, we offer clinically proven products designed to detect, diagnose and treat disease and other health conditions that primarily affect women-earlier and more accurately than ever to provide ever greater certainty and peace of mind. This focus has fueled our long track record of innovative medical breakthroughs across many therapeutic areas-breast health, cervical health, body composition, gynecologic health, perinatal health, skeletal health and sexual health-touching the lives of more than 230 million women around the world every year. In fact, as global champions for women's health, no company in the world has done more to fight cervical and breast cancer than Hologic-and we will continue to challenge ourselves to ensure that future generations of women have access to our life-saving innovations.

Of course, none of this would be possible without the talent and passion of our employees. Together, our collective expertise and dedication to develop and market robust, science-based certainty, sustain a pipeline of exceptional solutions that respond to the unmet health and wellness needs of women, families and communities. And when we fulfill our purpose and promise to the world, we also fulfill another goal: a business that generates sustainable global financial growth from which success and prosperity for our company, employees and investors naturally follow.

Job Summary

The Test Specialist 1 candidate will be responsible for understanding and executing testing on multiple assay platforms in a cGMP environment to ensure timely release of products. The candidate will be responsible for maintaining laboratory instruments, equipment and processes and supporting continuous improvement programs.

Duties & Responsibilities:

  • Perform testing and prepare reagents for Stability for On Market Products

  • Execute protocols as instructed keeping accurate records.

  • May prepare reports, deviations, or collect data related to testing.

  • May occasionally perform testing to support release of product.

  • Support department and Regulatory as required.

  • Generate root cause analysis reports for laboratory investigations.

  • Support investigational testing for NCE product failures

  • Contribute to document change control activities in Agile.

  • Collaborate with peers and supervisors to ensure business excellence.

  • Collaborate on 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.

  • 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 small group of peers.

  • Experience working in a timeline driven setting.

  • Ability to write clear and concise reports.

  • Ability to work in and/or lead cross-functional improvement teams.

Education

  • Bachelor's degree

Experience

  • 2 years related experience in testing in a cGMP regulated lab. Some laboratory testing experience a plus.

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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Operations Test Specialist 1 - Stability

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