Operations Test Specialist

Job Description

As a leading innovator of women's health, we at Hologic are empowering people to live healthier lives everywhere, every day.

Our manufacturing and operations teams sit at the core of what we do as a business, our innovations are designed to achieve exceptional clinical results making it possible to detect, diagnose and treat illnesses and other health conditions earlier and with more certainty.

In this role, you will be working as part of the analytical group within our Operations Testing Team. They do universal raw material testing before it goes into our finished product, using HPLC/UPLC, Mass-Spec, pH meters to name a few.

Think this role is for you?

You have the ability to run analytical instruments such as HPLC, UV-vis, and Mass Spec in order to perform release testing of incoming raw material, as well as in-process materials in support of our cGMP manufacturing operations.

You will also support the team with the identification and troubleshooting of problems with instrumentation, lab maintenance and being involved in continuous improvement efforts.

Key Outcomes:

• Perform QC testing using analytical methods for release of products and intermediates
• Run analytical instrumentation which includes HPLC, Mass Spec, UV-Vis among others.
• Maintain test schedules
• Generate root cause analysis reports for lab investigations, as well as sound retest designs for invalid or out-of-spec results.
• Support investigational testing for product failures or out-of-trend results.
• Create high-quality test procedures and SOPs to support new product introduction.
• Work with the LIMS team to ensure alignment between test procedures and LIMS methods.
• Present data to small groups of peers.

Do you have what it takes?

• You work well independently, as well as in a cross-functional team environment, you are able to communicate effectively with peers, interdepartmentally and with management, have meticulous attention to detail, strong troubleshooting skills, and the ability to solve technical issues.
• You have analytical chemistry experience, as well as experience operating analytical instrumentation, specifically HPLC.
• You have a good understanding of root cause analysis methods and knowledge of FDA CGMP and ISO 13485.

Additional qualifications:

• Bachelor's degree
• 0-2 years of QC or R&D hands-on experience (Level 1).
• 3-6 years of related experience in testing in a cGMP regulated lab (level 2).
• Analytical lab 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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About Us

Hologic is the market leader in the women's health industry with three different divisions, all offering unparalleled diagnostic and treatment solutions. In the regulated markets where businesses are awarded on a tender basis, our capability to win the deal comes from seamless combination of Customer solution definition (Commercial and Technical content) together with flawless execution of all tender requirements (Administrative content and process).

About the Team

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