Kelly Services Quality Assurance Associate in Palo Alto, California
Quality Assurance Associate, Palo Alto, CA
Develop, draft, and compile documents of clinical protocols for the Investigational New Drug IND and Chemistry Manufacturing and Controls CMC sections for submissions to Food and Drug Administration FDA , Institutional Review Board IRB etc.
Evaluate compliance of all completed manufacturing batch records, forms, etc. and quality control records test/analytical results to identify deviations.
Review deviations and determine if batch record should be escalated for additional review or investigation.
Provide guidance to Product Development/Manufacturing PD/MFG and Quality Control QC to ensure compliance with all applicable regulations and assist in resolution of issues identified.
Evaluate and analyze the impact of new regulations to determine how to implement within unit and make recommendations based on findings for implementation.
Oversee Quality Assurance contract manufacturing activities to ensure required quality standards are maintained based on cGMP current Good Manufacturing Practice regulations.
Perform independent review of documentation during and post-execution of cGMP activities.
Ensure all specifications are met and that applicable requirements are completed and acceptable.
Provide guidance and directives regarding remediation activities required to continue production. Continuously identify and manage issues to ensure quality control is maintained, compliant, and the issues have no impact to quality of product/process.
Ensure raw materials used for manufacturing and testing comply with cGMP requirements and ensure staff are trained as required.
Collaborate with PD/MFG and QC to resolved minor and major deviations and to execute continuous compliance with quality systems, internal SOPs Standard Operations Procedures , and regulatory requirements.
Actively participate in the mitigation of risks by identifying quality issues, determining corrective actions, minimizing reoccurrence, and evaluating quality impact.
Generate quality metrics including but not limited to deviation trends, CAPA effectiveness, EM excursions, product lot acceptance, confirmed OOS, product complaints rate, annual product review completion, per defined interval to ensure quality attributes are maintained.
Develop processes that enable routine execution and achievement of product/project timelines and contribute to completion of project milestone.
Participate in cGMP compliance audits of vendors, contract manufacturers, contract laboratories, and quality systems.
Ensure equipment qualification have been completed; preventive maintenance and calibration performed prior to due date.
Bachelor s degree in life sciences e.g. biology, chemistry, etc. .
Ability to effectively work in fast pace environment with cross functional groups involved in multiple projects and timelines.
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 9,000 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 2017 was $5.4 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.