Kelly Services Quality Assurance Associate in Boulder, Colorado

Product Quality Specialist- Temporary Assignment 6-12 months

Responsibilities:

Tracking receipt of batch records from contractors and properly securing and archiving of records. Review and approve contractor manufacturing, packaging, and analytical records to ensure completeness and consistency with company policies and procedures necessary for batch release of clinical and commercial intermediates, API and drug products. Report monthly quality metrics to QA Management for review. Maintain databases and systems used for tracking various GMP manufacturing associated support activities. Works closely with Regulatory, Supply Chain and Manufacturing, and contractors to prioritize documentation review and product release. Continually evaluate systems and procedures for improvement while ensuring compliance to applicable regulatory requirements and standards. Maintain documentation and records to ensure GMP Quality standards and compliance. Support Regulatory Authority inspections and internal external audits. May review and approve Array change control requests for product packaging and labeling specifications and master product batch records. May review contractor deviation investigations and initiate necessary records according to company procedures.

Requirements:

  • BA/BS with Biology/Chemistry focus or equivalent industry experience.

  • 3-5 years of Quality Assurance experience in a regulated or GxP environment preferred.

  • Experience in a virtual Quality role in a GMP environment for small molecule drug substances and dosage forms (oral and parenteral) preferred.

  • Strong organizational skills, ability to multitask in a dynamic, fast paced environment.

  • Demonstrated analytical and logic skills with a focus on fact-based decision making and problem-solving.

  • Strong collaboration and written /verbal communications skills.

  • Experience with MasterControl preferred.

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.

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