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Quality Assurance Associate

Kelly Services

Englewood, CO
Job Code:
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Job Details

Job Title Quality Assurance Associate

Jobid US15TPCS_BH1422087

Location: Englewood, CO, 80113, USA

Description **Quality Assurance Associate - Temp to Hire or for the right person Direct Hire $70-95K per year**

**Job Purpose and Function:**

Responsible for Quality Management System (QMS) maintenance including review and approval of validation documents, production/test records, investigations and change controls. Ensures proper operation of the QMS and compliance to internal procedures and regulatory requirements. A wide degree of independence, creativity and latitude is expected.

**Primary tasks include:**

+ Coordinate, track and report on the health of the Quality Management System. Perform internal audits and QA walk-throughs to regularly assess QMS health.
+ Review/approval of deviations, laboratory investigations, CAPAs and change controls
+ Review and author QMS SOPs
+ Review/approval of operational and laboratory Standard Operating Procedures (SOPs)
+ Review/approval of validation (IQ/OQ/PQ) protocols/reports to ensure compliance with internal procedures and regulatory expectations.
+ Collect Quality metrics for compliance council/management review
+ Manage supplier assurance program including initial audits, continuous monitoring, and maintenance of quality agreements.
+ Assist with batch production record review and product release
**Other tasks and responsibilities include:**

+ Internal audits and external audits
+ Writing investigations, validation reports, technical study reports
+ Other duties as required
**Key Skills Required:**

Requires a minimum of a bachelor's degree in Biological Sciences, Chemistry or relevant area with 3-5 years of experience in biotechnology/pharmaceutical industry (or related, regulated field). Direct experience in a GMP setting. Relies on extensive experience and judgment to plan and accomplish goals.

Experienced with a GMP compliant quality system including SOP, deviation, CAPA and change control review/approval. Experienced with internal/external auditing.

Understands aseptic processing and compliance requirements.

Strong Problem solving skills, i.e., Root Cause Analysis.

Specific work experience in regulated document control systems. Strong technical writing skills with the ability to use MS Word, MS Excel and other document applications. Must be able to provide advanced formatting for controlled documents.

**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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