Documentation Specialist

Processes controlled documentation in the EDMS (Electronic Documentation Management System) in accordance with policies and procedures. Reviews and evaluates changes requests of varying complexity with minimal supervision. Evaluates objective data and implementation plans associated with various change requests and follows up on activities required for closure. Serves as a primary contact for change initiators and provides guidance on the process as required. Evaluates and resolves quality issues with minimal supervision. Serves as a representative for Quality Documentation and Change Control during regulatory audits. Fulfill the responsibilities and tasks of the Change Control Manager in their absence as well as be a team lead and provide guidance and direction to other team members.

-Review evaluate and process change requests including:

• Objective data and implementation plans
• Provide guidance to change initiators as required
• Evaluate and resolve quality issues related to change control as required

-Complete processing of change request and associated documentation

-Identify potential process deficiencies and develop solutions for improvement

-Represent Documentation and Change Control during regulatory audits

-Assist Change Control Manager with special assignments/projects including:

• Participating in cross functional teams for site projects
• Representing Documentation and Change Control on global initiatives

-Other duties as assigned by Change Control Manager

Qualifications :

• Bachelors degree required in Life Sciences Engineering or similar discipline
• Minimum of 5 years of experience within a documentation services group and/or Quality function utilizing a validated documentation management system and change management system (preferably TrackWise).
• Minimum of 5 years of Quality or change control experience with an understanding of medical device documentation including but not limited to policies procedures work instructions specifications etc.
• Minimum of 5 years experience with supporting internal and external audits.
• Previous experience providing training to multiple departments as the SME.

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time