Hologic Operations Test Specialist 1 in San Diego, California
Operations Test Specialist 1
Post Date Jul 06, 2018
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.
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 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.
Maintain test schedules in a dynamic manufacturing environment.
Engage in technical development and quality training program.
Generate root cause analysis reports for laboratory investigations.
Support investigational testing for NCE product failures or out of trend results.
Contribute to document change control activities in Agile.
Collaborate with peers and supervisors to ensure business excellence.
Collaborate on continuous improvement projects.
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.
- Bachelor’s degree
- 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.