Manage the day to day activities within the quality control lab. Provide work direction and supervision of QC staff. Coordinate testing schedules, personnel scheduling and meetings with other departments to ensure timely completion of tasks. Monitoring and maintaining equipment. Major lab tests include endotoxin, protein purity, sterility, host cell DNA, host cell protein, SDS gels, and western blot. As needed, perform QC testing. Author and review technical documents, procedures and other related documents.
- Provide work direction to and supervision of the QC staff.
- Microbiology and/or biochemical assay qualification and routine testing.
- Coordinate 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.
- Create Certificate of analysis documents for finished products and assist product batch release.
- Initiate OOS and assist with deviations and CAPA.
- Trouble-shoot analytical process and equipment issues.
- Monitor and maintain QC Laboratory equipment and process validation status.
- Plan and test method execution to meet established delivery timelines.
- Perform QC tests such as SDS-gel analysis, Western Blot and RT-PCR for finished products.
- Oversee 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.
- BA/BS or Master’s degree in Biology, Molecular Biology, Cell Biology, Chemistry, or Biochemistry.
- If Bachelor Degree - 3-4 years of experience along with GMP experience.
- If Master’s Degree - 2-3 years of relevant experience along with GMP experience.
- At least 1 year of supervisory experience.
- Technical and practical understanding of the following analytical methodologies: electrophoretic (CE-SDS, SDS-PAGE, ie IEF), impurity (host cell protein ELISA, residual Host Cell Protein ELISA, etc.), endotoxin, sterility, RT-PCR, BacT, and other methods
- Attention to detail and strong organizational skills.
- Ability to multi-task, maintain a positive attitude/work environment.
- Knowledge of working in a GLP, cGMP environment.
- Knowledge of laboratory operations.
- General knowledge of computer systems and productivity software.
- Ability to speak, write and read English fluently.
- Good oral and written communication skills.
- Good personnel management experience
- Ability to resolve unexpected results
- Ability to easily work with diverse personnel at all levels of the organization
- Ability to adjust schedules to achieve desired results
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.