Electronic Batch Record Manager at Zoetis in Lincoln, Nebraska

Job Description:

States considered:



Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals.




At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in the Lincoln community. We are a clean, modern site that continues to innovate and grow.




Benefits Include:



4 weeks accrued paid vacation and 13 paid holidays.


401(k) match with company profit sharing.


Tuition reimbursement and Student Loan repayment program.


Great Health, personal, and family benefits starting day 1.



Position Summary



As a leader of people, the Electronic Batch Record Manager provides organization, priority, and leadership to the support team that drafts, updates, and develops production documentation such as batch records in the electronic system (PAS-X) and standard operating procedures. This role ensures clarity and efficiency in manufacturing operations while complying with all cGMP regulations.



Hours: 1st shift, Monday - Friday 8:00am - 4:30pm.




Position Responsibilities

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  Site System Administrator: Develop and oversee overall system procedures. Approve and assign system roles and ensure compliance.


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  Quality Oversight: Oversee the deployment and integration of the electronic batch record system across the organization to ensure alignment with Quality Systems and compliance with regulatory standards.


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  System Maintenance and Improvement: Ensure the EBR system is maintained, updated, and continuously improved to meet regulatory and operational requirements.


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  Team Productivity: Develop and/or review production documentation as needed, manage team productivity through organization and resourcing of active projects, facilitate cross-functional cooperative efforts, and lead site-level meetings for training and development.


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  Organize and Prioritize: Ensure site supply and strategic goals are met by organizing and prioritizing team efforts.


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  Monitor and Manage: Achieve delivery of short-term and mid-term goals by monitoring and managing team efforts. Lead and motivate others to meet commitments for projects and documentation needs.


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  24/7 Support: Respond to off-hour phone calls and coordinate escalation of issues in the electronic system (PAS-X).


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  Hiring and Resourcing: Responsible for hiring and determining appropriate resourcing to meet project and support needs for production support documentation at the site.


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  Coaching and Benchmarking: Coach team and facilitate benchmarking and discovery of best practices in the development and maintenance of cGMP production documentation.


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  Project Leadership: Lead site-wide projects to continuously improve the PAS-X program and records to achieve site goals and objectives.


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  Collaboration: Partner closely with Business Technology support during troubleshooting and communicate improvement needs.


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  Cross-Functional Teams: Participate in and lead cross-functional teams to continuously review and improve Change Control Management: Manage operations colleagues responsible for change control of documentation in Trackwise (ETS) and Veeva Vault.


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  Business Continuity Plan: Responsible for the site PAS-X Business Continuity Plan.


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  Other Duties: Perform other duties as assigned.

Education and Experience

• Bachelor's Degree (or experience equivalent) plus 2+ years related experience in design and formatting of documents.


• 10+ years' experience in a cGMP environment


• Pharmaceutical and cGMP process understanding.


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


• Experience using Trackwise (ETS) and Veeva Vault.


• Project Management experience using tools and methodologies.

PREFERRED QUALIFICATIONS

• General Electronic Batch Record experience in cGMP environment.


• Specific PAS-X Certification with authoring experience.


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


• Lean Six Sigma/Operational Excellence training and ability to apply Human Error reduction concepts.

Technical Skills and Competencies Required

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  Leadership and Teamwork: Demonstrated ability to lead and work effectively within a team, fostering a collaborative and productive work environment.


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  Continuous Improvement: Strong focus on continuous improvement, with the ability to identify and implement enhancements in processes and documentation.


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  Subject Matter Expertise: In-depth knowledge of production processes and cGMP documentation, ensuring robust and compliant documentation practices.


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  Communication Skills: Excellent verbal and written communication skills, with the ability to convey complex information clearly and effectively to diverse audiences.


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  Organizational Skills: Exceptional organizational abilities, with a keen attention to detail and the capacity to manage multiple tasks and deadlines.


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  Technical Proficiency: Proficient in using relevant software and tools, including Trackwise (ETS) and Veeva Vault, with an understanding of background tables and basic coding.


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  Problem-Solving: Strong problem-solving skills, with the ability to analyze issues, develop solutions, and implement corrective actions.


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  Interpersonal Skills: Ability to interact and communicate effectively with various stakeholders, including operators, technical services, IT, and leadership.


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  Presentation Skills: Competence in presenting important information to teams and leaders, ensuring clear understanding and alignment on operational documentation.

Physical Position Requirements

• Exposure to both office settings and a manufacturing environment, including moving mechanical parts.


• Stationary and standing/walking throughout the workday.


• Use of Personal Protective Equipment (PPE) such as hard hats, safety shoes, eye protection, gloves, and protective clothing when on the production floor.


• Occasional weekend and off-shift work to support a 24-hour/7-day operation.

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.


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. Apply Now