Team Lead - Operations Support, Documentation & Electronic Batch Records

Company: Zoetis, Inc
Location: Kalamazoo
Posted on: March 10, 2023

Job Description:

POSITION SUMMARYAs a leader of people, the Team Lead - Operations Support, Documentation & Electronic Batch Records provides organization, priority, and leadership to the support team that drafts, updates, and develops production documentation such as batch records in the electronic system (PASx/Werum) and standard operating procedures. This position leads the support team to provide expertise on document design to achieve clarity and efficiency in the manufacturing operations, while complying with all cGMP regulations.The successful candidate will possess strong team and leadership skills and will have a focus on continuous improvement in the workplace. Candidates will also use their subject matter expertise in production to provide robust cGMP documentation to the business areas. They must be able to interact and effectively communicate with a variety of people, including operators, tech services, IT, and leadership, to provide documents and document support in a timely manner. Participation on and leadership of cross-functional teams to continuously review and improve documentation system SOPs, business processes, safety and quality will be required.RESPONSIBILITIES

• Working lead - Contribute to team productivity by developing and/or reviewing production documentation (as needed) while managing the team productivity through organization and resourcing of active projects, facilitation of cross-functional cooperative efforts, and leading site-level meetings for training and development.
• Organize and prioritize the efforts of the team to ensure site supply and strategic goals are met.
• Monitors and manages the efforts of the team to achieve delivery of short-term and mid-term goals. Lead and motivate others to meet commitments for projects and documentation needs. Empowers colleagues to contribute their best efforts and results.
• Leadership Team member of a 24/7 support team. Expected to respond to off-hour phone calls and coordinate escalation of issues in the electronic system (PASx/Werum).
• Responsible for hiring and determination of appropriate resourcing to meet the project and support needs for production support documentation at the site.
• Coaches team and facilitates benchmarking and discovery of best practices in the development and maintenance of cGMP production documentation in the electronic batch record system (PASx/Werum) and hardcopy documentation (SOPs, etc.)BASIC QUALIFICATIONS
  • Bachelor's Degree plus 2+ years related experience in design and formatting of documents.
  • GMP and pharmaceutical process understanding.
  • Strong leadership skills, communication skills (both written and oral), and an ability to interact effectively with all levels of the organization is required.
  • 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.
  • Must be self-motivated and willing to learn new and changing responsibilities, with basic proficiency in project management and team facilitation.PREFERRED QUALIFICATIONS
    • General Electronic Batch Record experience in cGMP environment.
    • Specific Werum PAS/X Certification with authoring experience.
    • High proficiency in MS Word and tech writing experience desired.
    • Lean Six Sigma/Operational Excellence training and ability to apply Human Error reduction concepts.PHYSICAL/MENTAL REQUIREMENTS
      • Most of work is done in an office environment, some work on the production floor may be required.
      • Occasional weekend and off shift work will be required to support a 24-hour/7-day operation.Full timeRegularColleagueAny 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.

Keywords: Zoetis, Inc, Kalamazoo , Team Lead - Operations Support, Documentation & Electronic Batch Records, Other , Kalamazoo, Michigan