Quality Control Systems Specialist
Zoetis

Job Info

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Position Summary

The QC Systems Specialist acts as the Quality Control CVB Authorized Firm Sampler and 2020 sample submission subject matter expert. This role is an individual contributor role that focuses on maintaining compliance for respective areas, creating and maintaining scheduling, review of critical data for assessment and ensue timely communication with management. Creation and revision of standard operating procedures in alignment with Zoetis Quality standards and regulatory changes. The successful candidate must be a self starter and have the ability to prioritize work based on the needs of Production, Quality Assurance, Quality Control, Regulatory, GMT and Supply Chain.

Position Responsibilities

• Subject Matter Expect (SME) for APHIS 2020 samples submission for the Charles City site and have the ability to become a CVB authorized sampler.
• Process, enter into SAP MIC, Submit to CVB and warehouse Zoetis and CVB retentions (and RU retentions). Destroy samples post expiry.
• Clean retentions walk-in twice year and inspect monthly.
• Submit PLS Serials, Master Seeds and Reagents to CVB upon Regulatory direction.
• Process unlicensed materials (DEREA, AST, diluents): enter into SAP MIC and warehouse to appropriate storage. Destroy retains post expiry.
• Compose CoAs for Columbia(ICAs), Korea, New Zealand , Extraneous Agents for Egypt or Regulatory Afffairs, Antigens for Regulatory Affairs, FFMs, and obtain QA signature. Provide to requestor or post a copy to applicable location. File original documentation in serial packets or archive boxes.
• Review retention samples and complete Retention Evaluations for QA Product Complaints.
• Supply samples from retentions for retests, expired samples for VMRD for experiments, etc.
• Create archive boxes in PRESERVE, create spreadsheet to load into PRESERVE for storage and archive. Move scanned files into QC Scan Docs. Relocate box in Preserve and archive boxes to Doc Control.
• Research location of QC antigen testing packets in PRESERVE when additional testing needs to be added to scans/files.
• Working knowledge of regulations for testing of biological products; including 9CFR and European Pharmacopeia
• Cross functional role within the Quality Control office area to support 2008/CofA preparation and sample receipt/dispersal.
• Maintain appropriate departmental cGMP documentation.
• Reviewing and identifying processes, methods etc to ensure compliance with Regulations and filings.
• Completion of day to day responsibilities with minimal interaction and direction from team leader
• Support of the team leader for project management and communications
• Support and participate in inspections as required
• Follow all Zoetis Quality Standards, Policies and Procedures

Education and Experience

BA/BS degree in scientific discipline or business or 3-5 years applicable experience. 2-4 years of SAP/zLIMs knowledge and experience highly desirable.

• Strong commitment to product quality, customer service, and continuous improvement.

Technical Skills Requirements

• Proficient in Microsoft Word, Excel, Powerpoint, Outlook, QTS, pDocs/Veeva Vault and SAP/zLIMS
• Experience with 9CFR & EU regulatory requirements.
• Understanding of Outlines of Production/Special Outlines

Physical Requirements

• Must be able to walk or stand for long periods of time.
• Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
• Must be able to work scheduled 40 hours with the ability to work overtime as needed.
• Frequent lifting and carrying of 35 lbs
• Regular reaching, bending, stooping, and twisting
• Repetitive motion and substantial movement of the wrists, hands, and/or fingers
• Ability to work in hot and cold environments

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.

This job has expired.