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 Heath 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.
Your Missions Location: Lenexa, KS
Job Summary And Purpose 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 9CFR and/or Good Manufacturing Practices guidelines.
Responsibilities And Key Duties
- 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
Core Competencies
- 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
Technical / Functional Competencies
- 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
Qualifications 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 9CFR requirements
Physical 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
Working Conditions
- This is an onsite position.
Travel Required
- N/A
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.
- VEVRAA Federal Contractor
- Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.
669B
USCEVA
Your Profile 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 9CFR requirements