Quality Control Supervisor
Category: Quality Control
Shenandoah Biotechnology, Inc., a FUJIFILM Irvine Scientific company, is a leading manufacturer of recombinant proteins. Our vision is to provide a superior and affordable source of recombinant proteins to the academic and industrial scientific research communities. Our team are a passionate group from diverse backgrounds. Our headquarters and state-of-the-art, manufacturing facility is located in Warminster, Pennsylvania. Founded in April 2006, we joined Fujifilm Group in March 2022 and are rapidly expanding our operations.
At Shenandoah, rather than strive to be the largest, we strive to be the best. We are compassionate in our work, driven by integrity and dedicated to a superior standard of excellence. It is important to us to create a working environment for our employees that is filled with respect, humor and gratitude so we can give our very best to our customers.
We are hiring a Quality Control Supervisor. The Quality Control Supervisor will execute and supervise daily QC operations and testing of recombinant proteins for in process and final product release assays.
- Provide work direction to and supervision of the QC staff
- Microbiology and/or biochemical assay qualification and routine testing
- 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
- Sterility Assurance Specialist, Microbiology will provide technical expertise and guidance for all activities associated with Microbiology, Sterilization, and Aseptic programs to support Manufacturing,
- 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.) and compendial (pH, osmolality, bioburden, endotoxin, sterility) assays.
Experience / Education:
- 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
- Experience with analyzing samples using RT-PCR, BacT, and other testing 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.
Shenandoah Biotechnology, Inc., a FUJIFILM Irvine Scientific company is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable 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.