Kelly Services Senior QA Specialist (High Point, NC) in Durham, North Carolina

Kelly Services is currently seeking a DIRECT HIRE Senior QA Specialistâ for an esteemed client located in High Point, NC . The Sr. QA Specialist is an advanced level position with hands-on QA experience in a pharmaceutical environment that will work independently and under minimum supervision. This individual will be working primarily to support to Manufacturing operations. The Sr. QA Specialist, will assure products are manufactured in compliance with internal, regulatory and industry standards, meets business needs and optimizes cost in the quality organization of the manufacturing facility.

DIRECT HIRE + BENEFITS + RELOCATION ASSISTANCE

The ideal candidate will have:

  • Root-Cause Investigation and Statistical Analysis Experience.

  • Regulatory compliance and/or previous regulatory audit experience.

  • 10 + Years’ experience in QA, with a minimum of 3 years supporting GMP manufacturing, within the pharmaceutical industry

Responsibilities:

  • Perform a wide variety of quality assurance activities to ensure compliance with internal procedures, applicable US regulatory requirements, and customer requirements for drug substances under clinical development

  • Review and may approve documents such as standard operating procedures, manufacturing batch records, packaging and labeling records, test methods, specifications, stability protocols and reports

  • Review executed production batch records and associated documentation including any deviation and investigation reports related to lot release

  • Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations, quality investigations, CAPAs and change control; review and may approve quality system documents related to manufactured products

  • Perform product complaints investigations

  • Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines.

  • Assist with hosting and responding to client audits

  • Assist with developing and maintaining company’s quality system

  • Support continuous improvement of quality systems; author new, revise existing and may review department procedures and/or forms

  • Support quality systems, as needed (e.g., issue and track closure to change controls, deviations, quality investigations, CAPAs)

  • Assist with inspection preparation and inspection strategy room for regulatory agency inspection or third party audits

  • Serve as a backup to Senior Document Control Specialist, Associate Quality Assurance Scientist and Sr. Quality Assurance Scientist

  • In the absence of the Director, Quality Assurance provide guidance to the QA department.

Qualifications:

  • Bachelors of Science Desired: Bachelors of Science in Biology, Microbiology, Chemistry, Biochemistry, Pharmacy, Engineering, or related field.

  • Minimum of 5 years handling quality system investigations, CAPA, change control, etc.

  • Works independently with minimum supervision to accomplish goals

  • Good working knowledge and understanding of 21 CFR Parts 210, 211, and ICH Q7

Apply Today for Immediate Consideration!

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.