Document Control Associate

This Document Control Associate position is responsible for the day-to-day functions required of the department. Provide updates to QA Team Lead on progress of personal objectives and bring forward any deficiencies or issues identified within the specific areas of responsibility.

Position Responsibilities:

Know the governing regulatory agencies and an understanding of the regulations for those agencies as related to Document Control.

Day-to-day functions include, but are not limited to:

Completion of release documents for the EU (Batch Release Protocols (BRPs) / Passbills)

Issuance and reconciliation of controlled documents according to production work schedules (batch records, Veeva Vault documents, logbooks)

Finalizing of controlled documents (batch records, Veeva Vault documents)

Promoting documents into an electronic system (batch records, Veeva Vault documents)

Typing of necessary documents

Revision of department policies, procedures and logbooks

Archival and scanning of completed batch records, raw material packets

Archival of logbooks, master documents and misc. records.

Filing

Retrieval of records from archives for manufacturing, complaints and inspections

Reconcile paperwork from manufacturing into Document Control files

Destruction of documents after reaching retention period

Back-up duty includes release of semi-finished goods, antigens, seeds and medias.

Promotes teamwork and promotes innovative thinking to continuously identify and implement improvements, while managing the workload, objectives, and individual development.

Exhibits strong communication skills to coordinate needs with production colleagues

Exhibits strong attention to detail and ability to perform tasks right first time.

Exhibits organizational skills necessary to manage projects and maintain collaboration and consistencies between sites.

Issue status reports to all departments as outlined in standard operating procedures (SOPs).

Ensure documents requested for regulatory inspections are provided in a timely manner.

Manages own time to guarantee through-put of documents to ensure there is not a backlog and make risk-based decisions without a team leader present

Cross-train in all aspects of Document Control functions

Participate in the on-call schedule for the department

Lifting of up to ~50 is required

Education and Experience

Minimum of two years college education or equivalent experience.

Previous experience with the governing regulations and understanding of how those regulations apply to the business.

Skills promoting organization, teamwork, innovative thinking, attention to detail and quality.

Understanding of the job functions and responsibilities of Document Control (as per departmental policies/procedures, qualifications).

Background in Document Control or a basic understanding of the operations and paperwork flow of the business.

Computer experience with Outlook, Word, Excel, Access, Adobe Acrobat and SAP

Physical Requirements

Extensive computer work is necessary for this position.

Long periods of sitting may be required.

Ability to lift 50lbs.

Must be able to walk, sit, or stand for long periods of time.

Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.

Must be able to work scheduled 40 hours with the ability to work overtime as needed.

Regular reaching, bending, stooping, and twisting

Repetitive motion and substantial movement of the wrists, hands, and/or fingers

Full time

Regular

Colleague

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