Kelly Services Quality Assurance Manager in Boulder, Colorado

Quality Assurance Specialist II Lead

Salary 70-80K

Hours: 1:00 PM-11:00 PM

4-10 Schedule (Sun-Wed or Wed-Sat). One weekend day is mandatory

Responsible for quality oversight of incoming raw materials, manufacturing floor operations, facility/utility qualification and routine support, and QC laboratory investigations. This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing. This position will be responsible for review and approval of procedures and methods supporting all aspects of cGMP operations, including support of client and regulatory audits. Emphasis on this position is direct manufacturing support in the production environment.

Responsibilities:

  • Responsible for quality oversight of incoming raw materials, manufacturing floor operations, facility/utility qualification and routine support, and QC laboratory investigations.

  • This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing.

  • This position will be responsible for review and approval of procedures and methods supporting all aspects of cGMP operations, including support of client and regulatory audits.

  • Emphasis on this position is direct manufacturing support in the production environment.

  • Performs compliance review on the following records: batch record includes on-the-floor review of records; release data.

  • Reviews and approves Master Batch Records and Solution Records.

  • Reviews the following equipment-related documentation; CMMS work orders.

  • Interfaces directly with clients, provides updates and resolves issues.

Education and Qualifications

Bachelor's and 6 years of experience or Master's and 4 years' experience in a cGMP QA/QC environment or equivalent. Inter and intra departmental project management experience and experience with electronic document management systems.

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.