The Document Control Specialist position develops and maintains a comprehensive filing system and database for all documents to be retained in the document control center. This position manages the operation of the document control center to ensure the retrieval of documentation in a timely manner. The document control specialist must have the proper knowledge in management and administrative functions, possess the ability to coordinate and plan strategically, be proficient in communication, and be able to maintain critical thinking.

This position supports the quality processes for work performed by CEVA Animal Health, and its contractors, relative to vaccine development and licensure by the USDA as well in accordance with 9CFR and/or Good Manufacturing Practices guidelines.

• Responsible to maintain/support the comprehensive physical filing system and the digital library for completed production documents that are retained in the Ceva Animal Health archive

• Fulfill campus wide requests for documentation to assist in (but not limited to) investigations, research, and audits.

• Fulfill requests for logbooks which includes issuance and collection.

• Control access to and maintain the electronic (Quality Record Library) and manual files of original ancillary documents (i.e., autoclave logs, temperature logs, cleaning logs, environmental monitoring, and egg CoAs).

• Maintain security and access to the archive room.

• Prepare records for offsite storage and retrieval of those records when needed.

• Update and maintain logbook database to assign and control the issuance and archival of logbooks.

• Participate in QA designated continuous improvement projects (Lean).

• Provide documentation of output using KPI’s.

• Perform other related duties as assigned.

• Shape solutions out of complexity - Is open and curious of other perspectives

• Client focus - Has in mind client’s satisfaction

• Collaborate with empathy - Has a positive attitude towards collaboration

• Engage and develop - Clarifies short-term directions

• Drive ambition and accountability - Proactively manages own and others work

• Influence others - Communicates transparently

• Ability to prioritize multiple requests and daily workload efficiently

• Possess knowledge of Windows PC and Microsoft Office Tools (Word, Excel, Outlook, SharePoint)

• Ability to operate scanning equipment

• Ability to understand and execute written and verbal instructions

• Ability to communicate and interact effectively with team members and other departments

• Detail oriented and provide quality output

• Good clerical and administrative skills

• Document information completely and accurately

• Self-starter and proactive with flexible attitude

Education – associate degree or adequate relevant experience preferred

Work Experience – 1-2 years’ experience in a regulated industry (biotech preferred) or pharmaceutical industry performing document control processes.

Other (consider certifications, specialized knowledge and/or training, etc.) – Previous experience with quality systems; Working knowledge of current Good Manufacturing Practices, cGMPs, and 9CFR

• Ability to read, write legibly and communicate in English

• Tasks frequently require prolonged mental and visual concentration
• Bending, twisting, standing, and lifting up to 30 lbs. overhead on occasion

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This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job.This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job.This job description is not an employment contract.Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.