Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary opportunity to work as a Quality Assurance Specialist – Cleanroom-Environmental
at a prestigious Fortune 500® company working in Bothell, WA.
This is a 12-month temporary position at 40 hours per week.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “submit now” button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position (email@example.com) however your resume must be received via the “submit now” button included within.
The Quality Engineering team is responsible for providing Quality Assurance oversight of **Environmental** validation and engineering documents, test protocols, CAPAs, deviations, change control records, and additional site based technical documentation and activities. The position of QA Specialist - Environmental Oversight reports to the Manager, Quality Engineering. This position is based at the Manufacturing Plant located in Bothell, WA.
- Provide oversight of cleanroom environmental programs including environmental monitoring (EM), cleaning and sanitization, and facility controls.
- Review and approve complex documentation in support of GMP operations at, including but not limited to facility plans, validation and other technical protocols and reports, trend reports, risk assessments, standard operating procedures, CAPAs, deviations, etc.
- Proactively identify and resolve technical and compliance issues/gaps.
- Provide support to multiple areas within and, potentially, between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge.
- Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations (i.e. routine operations – calibration/maintenance, shutdowns, construction projects, etc.)
- Collaborate with stakeholders within and outside of the Manufacturing Facility, and communicate equipment, facility and system status; monitor progress and issue status reports
- **REQUIRES an environmental or microbiological QC background**
- Having some knowledge of validation process (for facilities & utilities) would be a PLUS
- Strong individual contributor with demonstrated ability to work independently
- Minimum of 8-10 years working in a Quality, Engineering, Manufacturing role (or combination thereof) within a commercial biopharmaceutical, cellular therapy, or gene therapy organization
- Knowledge of cGMP regulations, automation standards, FDA, EMA and PMDA guidelines applicable to biologics and cell therapy
- Direct experience with providing cleanroom guidance and support in a commercial biopharmaceutical, cellular therapy, or gene therapy organization strongly preferred
- Experience in Systems related to validation, calibration, maintenance, change control, and deviations strongly preferred
- Excellent communication, trouble shooting, and problem-solving skills
- Bachelor’s degree in a STEM discipline, additional disciplines may be considered if combined with relevant experience
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.