The QC Manager will manage QC personnel, provide strategy and direction for improving QC lab performance, and implement methods to ensure expedient test completion. Provide feedback to the organization and personnel on performance in an effort for continuous improvement. Ensure timely, accurate, complete testing to meet company, regulatory, and customer requirements.
Provide department strategy and direction in terms of staffing, equipment, planning, budgeting
Provide work direction to and supervision of the QC staff
Oversee implementation of new equipment and processes needed for business continuity.
Manage microbiology and/or biochemical assay qualification and routine testing
Manage environmental monitoring of utilities and classified rooms/spaces to support new utility and facility qualifications
Author and review technical documents, method transfer/qualification reports, standard operating procedures, change controls, and investigations for the performance of laboratory methods
Trouble-shoot analytical process and equipment issues
Monitor and maintain QC Laboratory equipment and process validation status.
Planning and test method execution to meet established delivery timelines
Laboratory maintenance including managing stock of reagents, consumables, and laboratory cleaning
Training of laboratory personnel in methods and procedures
Review of laboratory generated data and results
At least 2 years of supervisory experience .
Bachelor Degree 3-4 years of experience or Master’s Degree with 2-3 years of relevant experience
Experience in GMP
Knowledge of working in a GLP, cGMP environment
Knowledge of laboratory operations
General knowledge of computer systems and productivity software.
Knowledge of Endotoxin analysis, RT-PCR, BacT (Sterility), SDS PAGE analysis, Clean Room Operations, general QC equipment and office equipment
Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.
To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms/employment agencies to any employee at Fujifilm via-email, the Internet, or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.