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17 days old

Quality Assurance Associate II (Fremont, CA)

Kelly Services
Fremont, CA 94536
Quality Assurance Associate II



Fremont, CA



Req : 9534090



Date Start: 12/03/2019





Duties:




+ Works independently to provide quality assurance oversight of any area assigned where the business is responsible for adhering to current Good Manufacturing Practices cGMPs including Quality Control Systems and areas.

+ Demonstrates a high level of independent judgment and discretion in the timely identification, investigation and resolution of events impacting the Quality of products and processes.

+ Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans CAPA /Deviation management, impact assessments for changes to equipment and processes, risk management, and ensuring documentation and investigations meet all requirements.

+ With autonomy and authority, makes difficult decisions with little time for deliberation which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas.

+ Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls.

+ This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business.

+ Performs independent technical review of documentation during and post-execution of cGMP activities.

+ Ensures all specifications are met and that applicable requirements are completed and acceptable.

+ Ensures all issues/documentation associated with each process in assigned area have been resolved and approved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures.

+ Analyzes and reports findings to appropriate departments.



Skills:




+ Some Team Lead and/or Supervisory experience.

+ Attention to detail, good organizational and interpersonal skills, and problem solving skill.

+ Ability to prioritize and work under pressure.

+ Ability to work effectively and to respond quickly in a fast paced environment.

+ Knowledge of SAP, MS Word and Excel.



Education:




+ Bachelors decgree in Life Sciences or Engineering

+ Languages: English Read Write Speak

+ Certifications Licenses: CAPA






**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-11-27 Expires: 2019-12-28

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Quality Assurance Associate II (Fremont, CA)

Kelly Services
Fremont, CA 94536

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