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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
Responsible for the manufacture of bulk clinical and commercial kit reagents and for sub-assembly formulation, raw material prep and/or processing. Actively participate in transfer and support activities and continuous improvement on the existing processes. May be assigned to one or more functional areas in Operations.
 
Essential 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. 
  • Oversees and leads the daily operation activities of the BSL2/BLS3 laboratories.
  • Creates weekly production schedule including product support and transfer activities.
  • Able to perform 80% of mfg. activities in Production Microbiology and TPZ departments.
  • Provides and tracks department training.
  • Attends weekly production planning, support and transfer meetings, as required.
  • Writes monthly production reports.
  • Originates moderate to complex ECO/SCOs with no assistance.
  • May represent group at MRB.
  • Creates/revises production task lists and BOM lists to support Operations.
  • May reviews manufacturing documentation, including development and notebook studies for operations.
  • Participates in FDA, ISO lab audits and performs BSL3 audits.
  • May represent group as extended core team member on one or more core teams or on other teams.
  • Interfaces with R&D to learn new process and transfers knowledge to department.  Reviews and approves process transfer reports, as required.
  • Performs feasibility studies and assists in creating project plans.
  • Participates in Continuous Improvement from inception to completion.
  • Cross-train in other areas of mfg. & operations.
  • Oversees the execution of validation protocols for mfg. equipment and generates reports.
  • May perform ECO assessments.
  • Performs doc. owner activities for department.
 
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.
  • Knowledge of Microbiology/Molecular and Chemistry.
  • Working knowledge of laboratory safety and record keeping.
  • Strong mathematics skills.
  • Knowledge of ERP.
  • Knowledge of GMP/GLP, ISO and CDC Safety Regulations Blood Borne Pathogen Training.
 
Education:
Bachelor’s degree required
 
Experience:
2-4 years of related experience
 
 
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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