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

 

 

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

 

 

Notice: Zoetis Recruiters will contact candidates via email from an address ending in @zoetis.com and may also initially connect with candidates through LinkedIn, including LinkedIn InMail. Zoetis does not use Gmail, Outlook, Yahoo, or other web-based/generic email domains to communicate about job opportunities, interviews, or offers of employment. If you receive a recruitment-related email message claiming to be from Zoetis that does not come from @zoetis.com, please treat it as suspicious. For your security, do not reply, click links, open attachments, share personal or financial information, or send money in response to unexpected or questionable recruitment communications.

 

 

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.