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Quality Assurance Associate

Kelly Services

Boulder, CO
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Job Details

Job Title Quality Assurance Associate

Jobid US15TPCS_BH1435844

Location: Boulder, CO, 80305, USA

Description **QA Specialist, GMP Quality Assurance -** **_Temporary Position (Salary Range $22.00-$44.00 per hour depending on experience)_**

**_6 month assignment_**


This role will be responsible for the successful delivery of the GMP Quality Assurance and Compliance objectives through effective oversight, and implementation of quality initiatives.

The purpose of this assignment is to perform clinical and commercial batch record review and product approval. This person will track document receipts from contractors, revising existing and implementing new standard operating procedures and templates, continuous improvement of quality systems and processes, and archival of documents.


+ 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.
+ Review and approve labeling and packaging specifications, master records, and change control.
+ Review contractor investigations, deviations, complaints and initiate necessary records according to company procedures.
+ Report quality metrics to QA Management for review
+ Maintains databases and systems used for tracking various GMP manufacturing associated support activities
+ Generation and/or revision of GMP documentation such as standard operating procedures
+ 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

+ BA/BS with Biology/Chemistry focus or equivalent industry experience.
+ 5 years of experience in a regulated or GxP environment.
+ 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 relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda 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 and connectwith 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 iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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