Documentation Specialist

Document Control Coordinator responsible for managing and executing the initiation, processing, routing, distribution and archiving of cGMP records in accordance with internal and external regulations, policies, and procedures utilizing appropriate electronic systems.

Duties/Responsibilities:

• Perform all routine activities associated with the document change management system.
• Support the revision and creation of GMP documentation through the document change process. This includes, but is not limited to, performing routing, document processing, and formatting of documents.
• Perform all routine activities associated with manufacturing batch record issuance and reconciliation as well as creation, issuance and reconciliation of worksheets and logbooks which will require work inside classified manufacturing areas.
• Assist with the records management program, including interim and archive activities as well as managing shipments to Iron Mountain.
• Manage the retention of documentation in accordance with records retention schedules in conjunction with legal hold notices
• Perform document storage room activities such as filing, organization, barcoding in RMS and escorting personnel into the room.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

• This position requires demonstration of excellent organizational skills and attention to detail. Personnel must demonstrate flexibility and capability of multitasking, as well as demonstrate excellent oral and written communication skills and excellent computer competence. Effective interaction with all contacts is required. Personnel must also exercise sound judgment in assuring compliance with Regulations. Self-directed with ability to take initiative and follow through to completion on commitments. Ability to create effective change in a team based collaborative environment.

Education/Experience/ Licenses/Certifications:

High School diploma required, a college degree preferred with a minimum of 2 years experience.

Controlled documentation experience preferred.

GMP experience preferred.

Physical Demands:

Primarily an office based position with filing requiring sitting for prolonged periods, walking, repetitive use of arms, hands, wrists and reaching. Must be able to lift up to 20 lbs.

Work Environment:

Primarily an office based position with entry into manufacturing and warehouse facilities within classified areas requiring appropriate levels of PPE. May also require entry into laboratory spaces that require appropriate levels of PPE.

Entry into manufacturing area will require special gowning including removal of all makeup, jewelry and nail polish. Only plain wedding bands are allowed.

Travel:

This position requires up to 0% of travel

Supervisory Responsibilities:

N/A