Kelly Services 2nd shift Quality Assurance Specialist II, Vista, CA in Vista, California
2nd shift Quality Assurance Specialist II, Vista, CA
Kelly Scientific, a division of Kelly Services is seeking Quality Assurance Specialist II to work with one of our top GMP manufacturing facilities. This individual will conduct real time batch record review, perform internal audits, contribute to GMP system improvements, write technical documents, and review GMP documentation and reports.
Duties and Responsibilities
Review validation protocols, data and reports, as assigned
Coordinate assigned quality systems, such as GMP training program, deviations, CAPAs, or change controls
Perform annual product quality reviews and system reviews as assigned
Review raw material records
Provide support to customer and regulatory audits.
Conduct internal audits as assigned
Implement improvements in quality systems and SOPs
Review and update assigned documents, such as SOPs, , including line clearances, and shipment verification, equipment qualification and documentation control
Provide technical assistance on all production & quality systems documents
Organize and update document room files as required
Assist with ad hoc QA projects and other duties as assigned
BS degree in Science discipline - Chemistry, Chemical Engineering, Biology or equivalent
Minimum of 3 years’ experience in GMP compliance
Experience in GMP manufacturing, Quality Assurance and/or Quality Control
Experience with GMP document control, validation, qualification and calibration
Ability to work in ISO7 and ISO8 control environment and support real time batch record review
Experience in internal auditing as well as working with regulatory agencies
Ability to effectively organize, multitasks, and works in a fast-paced, deadline driven work environment.
Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues.
Excellent written and oral communications skills
Ability to work independently and manage one’s time
Communicate effectively and ability to function well in a team environment
Basic computer knowledge, including Microsoft Word and Excel (used daily)
Detail oriented with the ability to troubleshoot and resolve equipment problems
Questions? Call 858.207.6311 or 714.971.0721
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 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 career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm