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1+ months

QA Associate II - South San Francisco, CA

Kelly Services
Fremont, CA 94536
**QA Associate II - South San Francisco**



**Duties:**



This position is responsible for ensuring compliance and providing QA oversight of Fremont site according to cGMP regulations. Also responsible for implementing, maintaining, and monitoring Quality processes necessary for that assurance.



This includes:




+ Overseeing junior team members

+ Executing operations according to cGMP regulations

+ Identifying and implementing business process improvements that will drive business performance and Quality innovation.

+ 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 product, equipment, systems, or areas.

+ Requires strong interfaces with all functions in Fremont and BI network.



Key functions:




+ Manufacturing, E T, PS, and Quality.

+ Responsible for supporting batch disposition activities of internal and client products by review of batch deliverables CoA, deviations, change controls.

+ Support and represent Quality, Fremont and BI with clients on project teams.

+ Support manufacturing readiness with oversight of batch records, specifications, protocols.

+ Required to communicate with clients, external vendors and external services to resolve issues.

+ Responsible for providing quality oversight of quality systems for deviations, CAPAs and change controls.

+ Identifies, classifies and reports minor and major deviations.

+ Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone.

+ Works closely with others to determine root cause and potential preventative/corrective actions.

+ Ensures support for the timely closure of investigations.

+ Assess Quality documents and processes for continuous improvement opportunities.



**Skills:**




+ Strong communication, interpersonal and problem-solving skills.

+ Detail-oriented and resourceful.

+ Ability to prioritize and work under pressure to handle multiple timelines.

+ Able to work independently and collaborate in a team setting.

+ Demonstrate ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function.

+ Proficiency with MS Office products Word, Outlook, Excel, PowerPoint , SAP, TrackWise



**Education:**




+ Bachelor s Degree in relevant Life Sciences discipline.

+ Minimum of 6 years of relevant work experience in Quality in a highly regulated pharmaceutical environment.



**For immediate consideration apply today!**






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



Kelly Science is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**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

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Posted: 2020-04-06 Expires: 2020-06-06

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QA Associate II - South San Francisco, CA

Kelly Services
Fremont, CA 94536

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