Senior QA Specialist - GLPKelly Services, Inc. - Minneapolis, MN
Senior Quality Assurance Specialist – Coon Rapids, MNKelly Scientific Resources is currently seeking candidates for a Senior QA Specialist for one of our top clients in Coon Rapids, MN. Candidates will be considered on a temp-to-hire and direct hire basis, depending on qualifications. Schedule is Mon-Fri, 8am-4:30pm.As a Senior QA Specialist placed with Kelly Scientific Resources, you will perform data audits and report reviews to assure accuracy and compliance with Good Laboratory Practice (GLP) regulations, study protocols and laboratory Standard Operating Procedures (SOPs). The Sr. QA Specialist reviews protocols and amendments for GLP compliance, accuracy and compliance with US and international testing guidelines; assists with department and company training, and assists with coordinating and scheduling departmental activities; assists with client and government inspections, subcontractor inspections, data form reviews, critical phase inspections, facility inspections and equipment validation programs.Additional Job Responsibilities:
\tPerforms and documents critical phase audit activities for GLP compliant Studies.
\tPerforms and documents audits of final study director and principle investigator reports.
\tPrepares and signs quality assurance statements as required to be included in study reports.
\tPerforms and documents audits and technical reviews of equipment qualification, process validation and computer system validation reports.
\tPerforms and documents audit activities to support ISO17025 Internal Audit Requirements.
\tPerforms inspections of internal facilities and of subcontractor’s facilities and procedures for GLP and ISO17025 compliance.
\tMaintains written and signed records of auditing activities and submits written reports to management and study director.
\tProvides technical guidance to study directors and management for maintaining GLP compliance of assigned studies, departments or processes.
\tAssists in the development and review of standard operating procedures and associated quality documentation.
\tAssists with training and coaching department staff, and assists department manager in developing and providing training to APS management and staff.
\tAssists department managers in writing and publishing required management updates and internal audit reports.
\tAssists with client and government inspections.
\tAssists with the Internal Audit Schedule, CAPA program and Archives as assigned.
\tSchedules and tracks quality assurance audits, inspections and findings. Assists with coordinating and scheduling departmental activities.
\tMaintains copies of current protocols and amendments for assigned studies.
\tBachelor degree or equivalent, preferably in a scientific discipline field.
\t4 years GXP auditing experience in a preclinical laboratory environment and experience in preclinical medical device research.
\tWorking knowledge of GLP and ISO17025 regulations and the ability to interpret and apply these to daily work.
\tWorking knowledge of laboratory procedures and computer validated data collection systems in a preclinical environment.
\tThe ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate written and oral findings.
\tAn equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
\tStrong organizational skills, with the ability to handle multiple tasks.
\tStrong attention to detail.
\tGood oral and written communication skills, with the ability to interact appropriately with all levels of management and staff, client and regulatory personnel, and to work as part of a team.
\tMust be able to clearly speak, write, read, and understand English, including the ability to understand and verify scientific text and data.
Certifications/Licensures: The following certifications are desirable:
\tISO17025 audit certification
\tASQ Quality Auditor or Quality Manager
Why Kelly?As a Kelly Services employee, you will have access to numerous perks, including:
\tExposure to a variety of career opportunities as a result of our expansive network of client companies
\tCareer guides, information and tools to help you successfully position yourself throughout every stage of your career
\tAccess to more than 3,000 online training courses through our Kelly Learning Center
\tWeekly pay and service bonus plans
\tGroup- rate insurance options available immediately upon hire*
Apply Today! •Available for purchase and administered by a designated third-party vendor
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.
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.
5 days 14 hours ago
applySenior QA Specialist - GLP Kelly Services, Inc. - Minneapolis, MN, United States
William Russell Kelly founded the company in Detroit on October 7, 1946, operating as the Russell Kelly Office Service. He is widely credited with pioneering the modern temporary help industry. The company was renamed Kelly Girl Service in 1957, and it became Kelly Services® in 1966 to reflect the growing services of the company. Established in the International Marketplace In 1968, Kelly Services opened its first international office in Toronto, Ontario, Canada. The company’s first European office opened in 1972 in Paris, France. Today, we offer a full suite of outsourcing, consulting, and staffing solutions—delivered globally from over a 70-year heritage of dynamic talent innovations. Total Sales Revenue in 2016 was $5.3 billion. Fortune U.S. Rank Kelly Services is currently ranked 490 in the Fortune 500 list of America’s largest companies.
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