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10 days old

Regulatory Affairs Assistant

Kelly Services
Bunnell, FL 32110
Looking for a new exciting Career! Kelly Services is in need of a Regulatory Affairs Assistant



**Primary duties are:**



**1. Maintain Records, Master Files, Stability, Training, and Changes :**



a. From vendors, keep master records filed in appropriate binders current or scan to electronic storage developing . Compare completed batch records with master records on file per vendor and product. Advise Regulatory Affairs Manager of discrepancies.



b. Gather and compile stability reports received from vendors. Review reports against products specs and/or stability protocol requirements for accuracy. Report discrepancies to RA Manager.



c. Establish ongoing stability chart/spreadsheet to record annual stability requirements. Verify invoices against the chart/spreadsheet to confirm payment is required. Follow up with vendors when stability data is not received in a timely manner. Provide vendors with stability protocols according to the established schedule.



d. Team with RA group to follow up on training effectiveness plans. Maintain records of training and effectiveness plans on shared drive.



e. Maintain records of document and label changes according to established SOP.



**2. Participate in regular RA functions:**



a. Participate in audits conducted by regulatory authorities scheduled and unplanned . Provide requested records and support of the audit being conducted. Participate in post-audit discussions to further improve processes.



b. Team with RA group to execute annual Management Review Meeting and vendor evaluations. Assist in recording discussions, outputs and action items for compliance and improvement purposes.



c. Monitor the regulatory standing of CMOs verify FDA registration, confirm good standing with notified bodies. Keep records of CMO license renewals or cancellations to be entered into annual vendor evaluations.



**3. Provide customer care and service with product safety information SDS documents or suggest best product solutions to meet customer needs.**



a. Provide input to discussions and processes to advance the company mission with respect to customer and regulatory requirements.



b. Serve as backup to the RA Quality position i.e. inspection of in-house production and CMO production



c. Assist in providing support to International Sales positions for the requests of CPP / Export Certificate.



d. Team with RA to provide careful examination of labeling proofs.



**Skills-Knowledge-Abilities** :



1. Must effectively communicate by both written and verbal means with staff, vendors and customers.



2. Must have the ability to balance practical, defined organization structures with the flexibility to adapt to changing regulatory requirements and Company procedures.



3. Must have above-average working knowledge of MS Office products MS Excel, PowerPoint and Word.



4. Must be adaptable in regard to activities performed on a daily basis to be able to reprioritize daily assignments as situations change.



5. Must work well in a team environment while understanding individual contribution that supports the company mission.



6. Possess or acquire working knowledge of Food, Drug, and Medical Device standards applicable to current and future products and processes.





***Benefits are acquired after you are hired on permanant with the company***



**This is an Amazing Benefits package!!!!!!**



Medical/ Dental- 100% covered (No premiums)



Vision- approx. $6.18 /mo



Short term/life Insurance-100% covered



401k 1yr after



After 6 months- 5 days vacation/After 1 yr 2 weeks ( 10days)



PTO/ Sick days separate






**Why Kelly** **** **?**



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**About Kelly** ****




At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-10-14 Expires: 2020-11-14

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Regulatory Affairs Assistant

Kelly Services
Bunnell, FL 32110

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