Hologic Operations Scientist 1-2 in San Diego, California
Operations Scientist 1-2
Post Date Jan 09, 2019
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 Operations Scientist supports various areas of manufacturing including production and testing using technical knowledge for resolution of issues or improvements related to product or processes.
Duties & Responsibilities:
Support activities related to Stability Testing and scheduling of On Market Products.
Prepares and executes protocols and reports for product annual monitoring program. Under guidance, generates data summaries using statistical analysis.
May occasionally perform testing to support release of product and experiments to support investigations.
Generate clear and concise LI/NCE/deviations detailing event and impact to product and process.
Participates in efficiency improvement and cost savings initiatives.
Performs Design/Risk assessments for change orders as needed.
Collaborates in the execution of studies/projects with strategic impact.
Collaborates with internal customers to develop or modify policies and procedures.
May provide support during internal/external audits.
Support department and Regulatory needs as required.
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.
Basic understanding of stability requirements.
Basic understanding of root cause analysis and scientific method.
Conducts tasks in accordance with Good Laboratory Practices (GLP).
Ability to operate and perform limited trouble shooting of complex lab equipment.
Demonstrates strong peer to peer communication skills as well as possessing the ability to effectively communicate inter-departmentally and with management.
Demonstrates the ability to triage tasks with competing priority and recognize sense of urgency.
Adherence to FDA cGMP, ISO13485, company and department procedures.
Ability to work independently with moderate supervision on increasingly complex projects.
Ability to resolve technical issues.
BA or BS degree.
4-6 years related experience in scientific discipline.
- Knowledge of cGMP, QSR and ISO regulated environments including knowledge of compliance enforcement necessary for 510K and PMA products.
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.