Position : Change Control Specialist

Location : Tempe, AZ

Duration : 12 Months contract

Total Hours/week : 40.00

1st Shift

Client: Medical Device Company

Job Category: Admin/Clerical

Level Of Experience: Entry Level or Mid-Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Job Description Summary:

• Reviews and analyzes proposed changes to controlled documentation
• Verifies references and standards are current and active.
• Ensures documentation meets all local, segment, and corporate requirements will cross-train to other department functions.
• Implementation of documentation and change control using the electronic documentation and change control software
• Programs/software used include; JD Edwards, Master Control, Microsoft Word, Access, Excel, Microsoft Teams, and One Drive
• May participate in FDA, Corporate, and internal audits
• Data analysis and system report running

Responsibilities:

• This position requires participation as an active team member ensuring compliance to regulations, internal and external policies, and procedures.
• Responsibilities also include the processing of requested changes.
• Change Control Specialist is responsible for the maintenance of controlled documentation and supporting systems, update procedures using Word / Excel, ensure formatting is correct, and verify internal and external references.

• Follow and maintain local operating procedures, work instructions, assign approvers, etc.
• The position will include the ability to verify data entry fields are accurate.
• Works on straightforward tasks using established procedures; work is subject to review by others.
• Good attention to detail is a must.
• Ability to work in a team environment and to communicate clearly and effectively.
• Ability to multi-task and prioritize work load. Positive and professional attitude.

Experience:

• Experience in a documentation related position preferably in an FDA and/or regulated environment.
• Experience in Electronic Document Management System software, Master control is preferred.

• Medical Device Industry experience a plus.
• Experience in a regulated environment preferred, such as FDA, ISO.. etc.
• Minimum of an Associate’s Degree, Bachelor's degree highly preferred.

About Client:

Client, a leading global medical technology company that makes and sells medical devices, instrumented systems and reagents, is dedicated to improving people’s health throughout the world.

The Company’s capabilities are instrumental in combating many of the world’s most pressing diseases.

Founded in 1897 and headquartered in Franklin Lakes, New Jersey, Client employs more than 25,000 people in approximately 50 countries throughout the world.

The Company serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public.

It was one of the first companies to sell U.S.-made glass syringes. It was also a pioneer in the production of hypodermic needles and ranked #195 in the 2019 Fortune 500 list.

It was also listed among the top 100 companies in Newsweek's 2009 Green Rankings. Ranking of the 500 largest American corporations based on environmental performance, policies, and reputation. Placed third in the health care sector and 83rd overall

Keywords:

#ChangeControl #FDA #ISO #MedicalDevice #Documentation #MasterControl #JDEdwards #Word #Excel #DataEntry #OneDrive #ElectronicDocumentation