Electronic Batch Records (EBR) Specialist / Author

What is it like to work for Zoetis, the world leader in animal health? Zoetis means something a little different to every colleague, but at our core, our purpose 'to nurture the world and humankind by advancing care for animals,' is what unites us in all our roles.

We're a global animal health company dedicated to serving veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries. We're excited to become a part of the Metro Atlanta, GA, community as we build our newest manufacturing facility to support our growing monoclonal antibody and vaccine portfolios.

We are seeking a dedicated and detail-oriented Electronic Batch Record (EBR) Specialist / Author to join our team.

Position Summary

The EBR Specialist /Author will design and develop production batch record documents in the electronic system (PAS-X/Werum) to support assigned production areas. The candidate will provide expertise on document design to achieve clarity and efficiency in the manufacturing operations; while complying with all cGMP regulations The incumbent will serve operations customers to develop and/or modify documents which enable the manufacturing process. The ideal candidate will be self-motivated, a critical thinker, and capable of working independently or with a team.

(Near-term) Responsibilities in a Startup Environment: In a startup environment, the EBR Specialist will adapt quickly to changes, lead in developing and optimizing new processes, and identify opportunities for innovation and improvement. This role involves close collaboration with cross-functional teams, utilizing resources efficiently and troubleshooting unexpected challenges. The Specialist will also contribute to scaling of processes; participate in diverse tasks to support the dynamic needs of the startup; and ensure the sustainability and scalability of all procedures as the company grows.The successful candidate will need to be flexible to perform activities outside of the standard requirements and assist other departments.

Position Responsibilities

• Develop, implement, and support electronic batch record (EBR) system for the Atlanta Zoetis site.

• Research batch record needs for new product launch items or process changes (material changes, equipment upgrades/capital improvements, process improvements, etc.)

• Understand, follow, and complete process documentation in support of GMP (Good Manufacturing Practices).

• Accurately document production activities on paper and in computer-based systems.

• Consult process subject matter experts for input

• Design and build/author electronic batch records

• Build equipment & parameter tables

• Update records and tables as needed

• Present documents for review and route documents for approval

• Understand and follow safety policies as it relates to biological and chemical components and equipment to protect personnel and maintain product quality.

• Manage the timeline of implementation under team lead direction.

• Mentor and train colleagues as needed.

Education and Experience

• Associate's degree or equivalent experience

• At least 1+ years of related experience in design and formatting of documents

• Demonstrated GMP and pharmaceutical process understanding

Technical Skills and Competencies

• Computer/technical proficiency (understanding background tables, some coding required).

• Candidate must be able to handle changing deadlines with strong attention to detail.

• Must be able to work both independently and in a team environment. Individual will need to learn entire site process for documents including Artwork, Quality, Planning and Operations.

• Strong leadership skills, communication skills (both written and oral), and an ability to interact effectively with all levels of the organization is required.

• Must be self-motivated and willing to learn new and changing responsibilities, with basic proficiency in project management and team facilitation.

Preferred Qualifications:

• Bachelor's Degree

• Werum PAS/X Certification with authoring experience of GMBR's.

• High proficiency in MS Word and tech writing experience desired.

• Subject matter expertise in operations and equipment is desired.

• Human Performance training and ability to apply Human Error reduction concepts.

Physical Position Requirements

The majority of the work is completed in an office environment, but some work on the production floor will be required.The work conditions for this position include stationary and standing and walking throughout the workday. The colleague will be required to utilize certain Personal Protective Equipment, including but not limited to, hard hats, safety ("steel-toed") shoes, eye protection, gloves, and protective clothing when on the production floor.Occasional weekend and off shift work will be required to support a 24-hour/7-day operation.

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.