Quality Engineer - QC Microbiology Life Science at YOH Services LLC in Bothell, Washington

Job Description:

QC Microbiology Quality Engineer needed for a contract opportunity for Yoh Scientific's client located in the Bothell, WA area. This position is with a major pharmaceutical company that makes cancer and immunology drugs.  If you meet the requirements, please send your resume to Rachita.Saxena@yoh.com



12 month contract

Pay rate: $75 - $83.50/hr



The Quality Engineering team at Juno 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 Juno Manufacturing Plant (JuMP) located in Bothell, WA.



REQUIRED QUALIFICATIONS



* **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



EDUCATION REQUIREMENTS



* Bachelor's degree in a STEM discipline, additional disciplines may be considered if combined with relevant experience



PRIMARY RESPONSIBILITIES



* 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 JuMP, 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 JuMP Manufacturing Facility, and communicate equipment, facility and system status; monitor progress and issue status reports

 

Opportunity is Calling, Apply Now!

Recruiter: Rachita Saxena

Rachita.Saxena@yoh.com

What's In It For You?

We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.

*           Medical, Dental & Vision Benefits

*           401K Retirement Saving Plan

*           Life & Disability Insurance

*           Direct Deposit & weekly ePayroll

*           Employee Discount Programs

*           Referral Bonus Programs

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.