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22 days old

Document Control Coordinator

Kelly Services
Gaithersburg, MD 20898
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 **Document Control Coordinator** at a prestigious Fortune 500 company working in **Gaithersburg, MD.**





**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: Document Control Coordinator**





**Pay: $34.08 per hour depending on experience**




**Description**



The Document Control Coordinator oversees the revision, issuance and tracking of controlled documents used to support the Phase I/II/III and commercial GMP manufacture of bulk and sterile fill biologics. Mature professional capable of working independently and in a team setting. Continually evaluate opportunities for improvement to increase efficiency while ensuring compliance to applicable regulatory requirements and standards. Requires the ability to produce results in a fast-paced environment to meet client deadlines and to effectively prioritize based on criticality.


This is a first shift position residing at our Gaithersburg site in Montgomery County.


Job Duties:

Will work directly with Clients, the QA department and other Paragon departments to revise, issue and track controlled documents to meet timelines. Provide status updates and reminders when necessary.

Filing, tracking and archival of GMP documentation.

Provides reports to Upper Management and Project Management regarding document status

Maintains databases used for tracking various GMP documentation.

Support regulatory (FDA, EMA) and client audits/inspections of Paragon

Will work closely with various departments at Paragon to resolve quality issues and offer assistance as needed.

Processes, distributes, and maintains controlled documentation (i.e., SOPs, SMPs, material specification, logbooks, etc.) using a document control system.

Issuance of Batch Production Records.


Experience & Education:

High School Diploma and 6 years experience with Good Manufacturing Practices (GMPs) in the pharmaceutical, biologic or medical device industries in a Document Control position, including the revision, issuance and tracking of batch records, Standard Operating Procedures (SOP), Specifications, etc.

Microsoft Word and Microsoft Access experience

Exposure to 21 CFR Parts 210 & 211, biotechnology, Process Development (PD) and electronic validated computer systems a plus.

Experience with Electronic Database Management System strongly preferred.





**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** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**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: 2020-10-02 Expires: 2020-11-02

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Document Control Coordinator

Kelly Services
Gaithersburg, MD 20898

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