QO Data/Lab Analyst (1st Shift)
Company: Zoetis, Inc
Location: Kalamazoo
Posted on: August 6, 2022
Job Description:
The QO Data/Lab Analyst supports the management of raw materials
and drug products storage for stability studies and retains in the
lab. This role is critical to the management of stored inventory,
timely QC testing of stability batches, and compliance reporting of
stability data.
- Oversee the creation and revision of stability study protocols,
reports, SOP's, and quality stability records compliant with ICH
guidelines and other regulatory expectations.
- Initiate stability studies including necessary documentation,
initiation in stability database, choosing appropriate locations
within chambers, and charging samples into the chambers.
- Determine stability sample requirements and oversee execution
of stability protocol cross-functionally.
- Coordinate, receive and organize samples for stability
studies.
- Assist with data queries and analytical data analysis.
- Review and approve completed stability reports.
- Manage APR reporting, specification, stability data entry and
all associated trending.
- Manage and archive the cGMP stability documentation.
- Track, trend, and report on key quality stability performance
indicators and deliverables.
- Provide additional support to the QC/QA team as determined by
the QC/QA Manager.
- Work with other departments to develop and manage short-term
stability studies on lab scale and engineering batches to support
formulation and process development.
- Participate in FDA/Regulatory/Client audits as necessary.
- Drive investigations related to out of specification or out of
trend results, as necessary.EDUCATION AND EXPERIENCE
- BA/BS in Chemistry, Microbiology, Biology, or related science
discipline with a minimum of 2-4 years experience in a GMP
Pharmaceutical manufacturing environment desired.
- Candidate should possess basic computer skills such as data
entry with a high level of attention to detail. Experience with
Excel, MiniTab, SAP, Empower, TrackWise, Veeva Vault, and LIMS
systems are highly preferred.
- The successful candidate will also demonstrate the ability to
organize time independently and prioritized their workload to meet
objectives in a flexible, team-oriented environment.
- Excellent oral and written communication, as well as strong
technical and analytical problem-solving skills are critical. This
position requires leadership/project management ability and a
dedication to meeting timelines.
- Job duties involve occasional lifting (less than 35 lbs),
reaching, and sitting while working at computer terminal.
- Candidate must not be cephalosporin/penicillin sensitive.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 , QO Data/Lab Analyst (1st Shift), Professions , Kalamazoo, Michigan
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