SunnyvaleRecruiter
the smart solution for Sunnyvale jobs

Quality Assurance Senior Specialist - Environmental Monitoring

Company: Miltenyi Biotec Inc
Location: Sunnyvale
Posted on: April 16, 2019

Job Description:

QUALITY ASSURANCE SENIOR SPECIALIST - ENVIRONMENTAL MONITORING
SUNNYVALE, CA

Your Tasks
As a member of the Miltenyi Biotec Quality team, you will have the opportunity to develop, establish, implement and maintain the Site Microbial Contamination Control program for cell therapy products in a GMP environment. You will have the opportunity to provide QA oversight of the Environmental Monitoring program and Aseptic Processing Simulation activities, drive microbial contamination deviations and ensure that the proper CAPAs are effectively implemented. You will also have the opportunity to oversee cleaning and disinfectant qualification, cleaning validation program and drive risk management and change controls. You will work jointly with other units across the site to develop and maintain processes and procedures to ensure appropriate quality oversight while demonstrating compliance with cGMP for the Sunnyvale site's clinical and commercial pipelines. Additionally, you will be responsible for overseeing the validation program for QC Microbiology. The unique duties of this position will consist of coordinating release for final cell-based therapeutic products for clinical applications. Overall, your leadership ability and deep knowledge of quality will champion the continued development of Miltenyi Biotec products and growing success.

Requirements
* B.S. degree in Microbiology, a scientific discipline or equivalent
* Minimum of 5 years' progressive experience in Quality Assurance; or equivalent combination of education and experience.
* Experience in aseptic processing, cell therapy, and FDA inspections
* Strong knowledge of US and EU pharmaceutical GMPs

Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment. The noise level in the work environment is usually moderate.

Miltenyi Biotec is a company that is transforming and progressing. Our culture is one of bold scientific innovation. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.

At Miltenyi Biotec Inc., we have developed state of the art manufacturing processes for innovative cellular therapies. We are scientists, engineers, physicians, support specialists, and more - all dedicated to improving scientific understanding and impacting human lives. At our Sunnyvale facility we strive to find solutions to both the technical and conceptual barriers to enable development of cell and gene therapy approaches for the treatment of human disease.

Miltenyi Biotec, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Keywords: Miltenyi Biotec Inc, Sunnyvale , Quality Assurance Senior Specialist - Environmental Monitoring, Other , Sunnyvale, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Real Estate Associate - Licensed Only
Description: Whether you are a newly licensed real estate agent or a seasoned professional with another company, you have to check out Keller Williams Helping agents create a life by design is our only job. KW is (more...)
Company: Keller Williams Realty
Location: Oakland
Posted on: 04/23/2019

Revenue Officer
Description: PROGRAM MANAGER III- EPMO br 7,015.91- 9,008.56/mo.
Company: City Stockton
Location: Stockton
Posted on: 04/23/2019

Senior Scientist I, Medicinal Chemistry
Description: Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. (more...)
Company: Pharmacyclics, LLC
Location: Sunnyvale
Posted on: 04/23/2019


Real Estate - Licensed Associate Needed
Description: Whether you are a newly licensed real estate agent or a seasoned professional with another company, you have to check out Keller Williams Helping agents create a life by design is our only job. KW is (more...)
Company: Keller Williams Realty
Location: Oakland
Posted on: 04/23/2019

737 First Officer
Description: ID: 2019-2353 of Openings: 1Category: OtherOverview br br Flight Crews are responsible for the safe and reliable operation of our fleet of Boeing 777's and 737's. br br Atlas Air Worldwide is (more...)
Company: Atlas Air
Location: Modesto
Posted on: 04/23/2019

Part - Time Chemist
Description: Sunnyvale Company manufactures pellicles for the semi-conductor industry. It seeks a dependable, self-motivated, organized Part-Time Chemist to conduct research,
Company: Micro Lithography, Inc.
Location: Sunnyvale
Posted on: 04/23/2019

Support Counselor II
Description: What's Your Calling You can find a job or you can find your mission. We want you to help us make a meaningful difference. Aspiranet is a one-of-a-kind social service agency dedicated to building a world (more...)
Company: Aspiranet
Location: Turlock
Posted on: 04/23/2019

Uber Eats Part-Time Delivery
Description: Deliver with Uber. Earn on your schedule. br Work on your schedule. Deliver for a few hours in the mornings, every night, or just on weekends-it's up to you. br Earn Good Money. You'll earn by bringing (more...)
Company: Uber Eats
Location: Sunnyvale
Posted on: 04/23/2019

Reverse Mortgage Loan Officer - Commission Only, License, 1
Description: Employer is currently seeking Commission Only Reverse Mortgage Loan Officers in your area. This is a commission-only based position and is meant for experienced Reverse Mortgage Loan
Company: Job Trim
Location: Modesto
Posted on: 04/23/2019

CPH# JOB-2545133 - PT Outpatient Position Open in CA for the
Description: This opportunity is available for an outpatient setting for 13 weeks in California.
Company: CompHealth
Location: Oakland
Posted on: 04/23/2019

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Sunnyvale RSS job feeds