Quality Assurance Supervisor
Category: Quality Assurance
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 Assurance Supervisor. The Quality Assurance Supervisor will supervise the Company’s Quality Assurance personnel and activities including incoming QA inspection raw materials, raw material qualification program, change notification, final product release, and various customer and internal support as required.
- Supervise QA Incoming Inspection function and personnel.
- Supervise product Final Release function and personnel.
- Supervise raw material qualification program including maintenance of data bases and records, and change notification.
- Assist with customer audit program including scheduling, pre- and post-audit activities.
- Provide customer support in areas such as completion of surveys, providing raw material information, and related QA support.
- Assist in activities related to the preparation for and conduct of FDA and Notified Body inspections and customer audits.
- Assist with deviations, CAPA and associated actions and status.
- Assist with validations planning, coordinating, execution, completion.
- Assist and support Quality Systems management in the conduct of daily operations of the department and within the Company as required.
- Trend and Analyze Quality Indicators. Provide input as to appropriate corrective and preventive actions and suggest plans for improvement.
- Other duties as assigned.
Experience / Education:
- S. in Microbiology/Chemistry/Biology/Chemical Engineering or equivalent experience preferred
- A minimum of six (6) years of Quality Assurance in medical device manufacturing or equivalent.
- A minimum of 3 years in a managerial position
- Proficiency in current versions of MS Word, Excel
- Excellent communication and collaboration skills
- Ensure that requirements are met in all regulatory, compliance and registration functions as prescribed by the FDA’s GMPs (QSR), ISO 13485 and USP 1043.
- Current industry regulations, i.e. detailed understanding of ISO 9001, 21CFR 210 & 211-cGMP, FDA QSR 820, ISO13485, and USP 1043.
- Ability to speak, write, and read English.
- 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.