QA Document Control Specialist - File Room

QA Document Control Specialist - File Room

The success of a company depends on the passionate people we partner with.

Together, let's share our talents.

As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing, producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.

We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.

Indeed, our "Together, Beyond Animal Health" vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.

As part of our "Diversity, Equity and Inclusion" policy, Ceva Animal Health is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

Location:

Lenexa, KS

The Document Control Specialist position is responsible for supporting a comprehensive physical filing system and digital library for executed production records and supporting documents requiring retention per regulatory requirements and Corporate Ceva expectations.

This position supports the quality processes for work performed by Ceva Animal Health (Lenexa Bio), and its contractors, relative to vaccine development and licensure by the USDA, in accordance with 9

CFR and/or Good Manufacturing Practices guidelines.

• Sort and file original paper documents within the Document Control File Room (i.e., production records, autoclave logs, temperature logs, cleaning logs, environmental monitoring records, raw material CoAs, etc.) using existing file structure
• Accurately scan and upload production records and other supporting records to the Quality Record Library for easy retrieval
• Fulfill campus-wide requests for documentation to support investigations, research, audits, etc.
• Assist in logbook creation and archival
• Aid in preparing records for offsite storage to maximize onsite storage
• Supports all regulatory inspections, prioritizing document retrieval
• 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

• Organized and detail-oriented with a Quality mindset
• Good clerical and administrative skills
• Self-starter with the ability to prioritize multiple requests and daily workload
• Ability to work in a fast-paced environment with flexibility to adjust with shifting priorities
• Working knowledge of Windows PC and Microsoft Office Tools (Word, Excel, Outlook, SharePoint)
• Ability to operate scanning equipment
• Ability to understand and execute both written and verbal instruction
• Ability to communicate and interact effectively with team members and other departments

Education – Minimum High School Diploma. Associates degree preferred.

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

Other – Previous Quality Systems experience and working knowledge of cGMPs and 9

CFR requirements.

• 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

• This is an onsite position.

• N/A

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