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Regulatory Compliance Specialist

Kelly Services


Location:
Fort Worth, TX
Date:
04/18/2018
2018-04-182018-05-17
Job Code:
US41L7BS_BH1428585
Kelly Services
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Job Details

Job Title Regulatory Compliance Specialist

Jobid US41L7BS_BH1428585

Location: Fort Worth, TX, 76101, USA

Description Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Regulatory Compliance Specialist** at a prestigious Fortune 500® company working in **Fort Worth, TX.**

**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within.

**Job Title: Regulatory Compliance Specialist**
**Duties**

Using references and knowledge of relevant guidance/regulatory documents, perform compliance activities supporting Change
Control and Regulatory documentation related to registration support, artwork management, specification updates and other quality activities as assigned.

Impact

· Ensure compliance to internal procedures and external guidelines
Maximize on-time completion of compliance actions
· Minimize delays leading to manufacturing stock out

**Skills**

5-7 years applicable experience in pharmaceutical manufacturing, Medical Device, or related industry including 1 year in Quality Assurance.
· Computer, Microsoft Office
· Problem solving
· Strong Written and Verbal communication
· Strong math skills to include statistics
Desired:
· Knowledge of external regulatory requirements and pharmacopeia (especially 21CFR210/211/820, EU GMP, USP, Ph EU, JPAL)
· Experience facilitating external inspections audits by regulatory bodies/ministry of health/Food and Drug Administration
· Experience conducting internal audits and/or supplier audits for pharmaceutical and/or medical device
· Experience in quality over site of supplier, operations, validations and documentation
· Experience authoring/approving ANDA/NDA/510K submissions and subsequent responses to regulatory bodies/ministry of health/Food and Drug Administration
· Experience authoring compliance documentation such as Annual Product Reviews (APR) and Change Control
· Experience with drug/device labeling requirements for US and international
· Experience with general chemistry and/or microbiology methods and laboratory operations
· Experience with manufacturing process and analytical method validation
· Experience with training other associates
· Experience with LIMS and ERP Systems (JDE ARMS)

**Education**
Bachelors of Science in Biology, Chemistry and/ or

Specialty training and certification in Pharmacy, Regulatory and Document Management

**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com at http://www.kellyservices.com/ **.**

**_Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**

**Kelly Services is an Equal Opportunity Employer**

**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 kellyservices.com 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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