Document Control Associate

Zoetis Spain SL; Charles City (IA); Ibrido; USD 42.000 - 65.000; Tempo pieno

Descrizione del lavoro

Zoetis Spain SL seeks a Document Control Associate to handle day-to-day duties in document control, ensuring timely release and reconciliation of records. You will manage batch records, Veeva Vault documents, and logbooks, while promoting adherence to SOPs and regulatory requirements.

Responsibilities include archiving, filing, retrieval for inspections, and cross-training across the control functions. The role requires attention to detail, teamwork, and the ability to lift up to 50 lbs as

Competenze

• Minimum of two years college education or equivalent experience.
• Experience with governing regulations and understanding of how those regulations apply to the business.
• Promoting organization, teamwork, innovative thinking, attention to detail and quality.
• Understanding of the job functions and responsibilities of Document Control.

Mansioni

• Know the governing regulatory agencies and an understanding of the regulations for those agencies as related to Document Control.
• Completion of release documents for the EU (BRPs / Passbills) and issuance/reconciliation of controlled documents.
• Finalizing and promoting documents in an electronic system (batch records, Veeva Vault documents).
• Typing, revision of SOPs, policies, logbooks; archival and scanning of records.
• Filing, retrieval of records for manufacturing, complaints and inspections; destruction after retention period.
• Participate in on-call schedule and assist with cross-training; lift up to ~50 lbs.

Conoscenze

Attention to detail

Organizational skills

Teamwork

Communication skills

Problem solving

Microsoft Office

SAP

Formazione

Two years college education or equivalent experience

Strumenti

Veeva Vault

SAP

Adobe Acrobat

MS Excel

Descrizione del lavoro

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