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
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