Hologic Production Chemist IV (TPZ Lead) in San Diego, California
Production Chemist IV (TPZ Lead)
Post Date 5 days ago
This position is for the Lead Production Chemist in TPZ Manufacturing . The selected candidate is expected to be a leader in safety, quality, and continuous improvement within the TPZ team. He or she will be responsible for a wide variety of tasks such as tracking metrics, production scheduling, nonconformance investigation, batch record review, bulk formulation, and training of department personnel.
Duties & 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.
Drive a culture of safety, quality and continuous improvement on the manufacturing floor
Develop and maintain the weekly production schedule to optimize production efficiency
Execute bulk formulation, reagent filling, and other lab activities
Review and approve manufacturing batch records
Act as a technical expert for the manufacturing area
Resolve minor issues ensuring production schedule is on track
Monitor and update production metrics
Perform NCR and customer complaint investigations
Assist with internal and external audits
Lead and monitor training of department personnel
Perform Lab audits for cGMP and safety compliance
Audit and sustaining 6S in manufacturing suites
Cycle count entry, variance investigation and justification write-up
Implement Continuous Improvement and cost saving ideas
Provide weekly Hot Topics in absence of the Supervisor
Identify and implement SOP/Mfg batch record improvements
Review, monitor, and edit production routings as needed for accuracy
Coordinate with Quality Micro for EM requirements
Monitor scheduled Analyte Changeovers and request timely QA Room Releases
Assist with process transfers and development manufacturing
Schedule and coordinate vendor activities
iProcurement orders (CCS POs, Orbis, VWR, MSC, general lab supplies)
Review and approve ECOs and SCOs
Ensure lab supplies and non-inventory items are available and replenished as needed
Responsible for CAPA/Task completion, tracking, date extensions, audit findings, etc.
Create PDVs and product Test Plans as needed
Act as point of contact for 2 nd shift employees in TPZ
Provide training to the manufacturing team
Generate Facility Service Requests and Change Controls
Coordinate lab shutdown activities to prevent production disruption
Perform backup activities for Supervisor and other duties as needed
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.
Advanced GMP and safety knowledge.
Understanding of Planning function
Strong technical understanding and experience in one or more manufacturing areas.
Document owner for department.
Good presentation skills
Technical writing skills
- Typically requires BA or BS
- Typically a minimum of 2-5 years 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.