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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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