We're looking for a **QC Associate III** , working in the
**Pharmaceuticals & Medical Products** industry in **Fremont,
+ Responsible for providing Quality & Compliance oversight to
site qualification / validation projects related to installations,
changes and upgrades to automated systems.
+ Responsible for ensuring the site policies and regulatory
requirements are followed for computer system commissioning,
qualification and validation projects on site.
+ Participate in project teams and will review and approve
computer validation related documentation for automated systems
including but not limited to Validation Plans, User Requirements,
Specifications, FATs, SATs, IOQs and PQs.
+ Signatory responsibilities for all qualifications/validation
issues associated with assigned area(s).
Our client is an award-winning clinical development company.
Improving lives globally with 20+ years experience in clinical
research and strategic resourcing. Elevating results with proven
strategies, comprehensive solutions, and customized delivery
Serving pharmaceutical, biopharmaceutical, biotechnology, and
medical device organizations.
Strong relationships provide you connections and access to great
opportunities. Industry expertise sets you up for success with
helpful insights, career coaching, and professional training. Grow
and learn while you put your skills to work.
**Experience Required for Your Success**
+ Bachelors degree in Engineering, Computers or related
+ Minimum of 5 years experience in a GMP regulated environment
working on validation of automated systems
+ Broad experience and knowledge in the following areas:
Knowledge of 21CFR Part 11, Annex 11 and GAMP V Experience in
commissioning and Qualification of control systems
+ Experience with a variety of control systems including DCS,
PLCs and SCADA
+ Experience with HMI SCADA systems such as iFIX, Rockwell
RSView and Wonderware
+ Experience with Batch Systems such as Proficy batch execution
+ Experience with PLCs such as Rockwell GE Fanuc, Siemens and
The pay range we are offering is **35 to** **45** per hour. This
position may present an opportunity to go permanent.
**What Do You Think?**
Does your experience reflect what it takes to be successful in
this role? Do the work and challenges get you excited about what's
possible? Apply here .
Not exactly? Join Our Talent Community
(https://jobs.psgglobalsolutions.com/register) , and we'll let you
know of additional opportunities.
EOE Protected Veterans/Disability