Compliance Specialist
Compliance Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Zoetis is the worlds largest Manufacturer and Supplier of Animal Pharmaceuticals.
At Zoetis in Lincoln NE we manufacture high quality medicines for dogs cats and livestock. Our plant has been recognized as one of the Nebraskas Safest Companies with a long-standing presence in the Lincoln community. We are a clean modern site that continues to innovate and grow.
Benefits Include:
4 weeks accrued paid vacation and 13 paid holidays.
401(k) match with company profit sharing.
Tuition reimbursement and Student Loan repayment program.
Great Health personal and family benefits starting day 1.
Position Summary
Perform activities necessary to maintain regulatory documentation and process controls to ensure program compliance with FDA USDA International Market GMP regulations Global Quality Standards and other applicable regulations as well as site policies and procedures.
Hours: 1st shift hours Monday Friday.
Position Responsibilities
- Lead and manage change control processes for QC labs including regulatory document updates (e.g. LIMS MCD revisions impact assessments).
- Review and audit study protocols reports and data files to ensure regulatory compliance and data integrity.
- Drive closure of internal and regulatory audit compliance actions and support annual compliance assessments.
- Coordinate the Outline Review process and assist with reagent shipments to regulatory agencies.
- Participate in QC compliance investigations and support the BCL Surveillance Program.
- Organize and lead monthly team leader meetings lab walkthroughs and working sessions to enhance collaboration and compliance.
- Streamline SOPs and lab processes ensuring timely completion of ETS and VV commitments.
- Track and analyze lab metrics for process improvement and provide compliance support across all lab teams.
- Complete projects assigned by senior departmental personnel within specified timelines.
Education and Experience
Required Qualifications:
B.A./B.S. in science or related degree with equivalent experience. Minimum of 5 years relevant experience. General understanding of contemporary & traditional bacteriology & virology techniques and validation principles. Thorough knowledge of 9CFR and EU regulations Good Manufacturing Practices (GMPs) Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs).
Preferred Candidate Qualification:
M.A./M.S. in biological or molecular biological sciences with a minimum of 3 years relevant experience; skills in immuno- biochemical or molecular biological assays. Experience in USDA and VMD regulations with knowledge of 9CFR 113.8. Prior quality assurance experience regarding documentation and change control systems.
Technical Skills and Competencies Required
Demonstrated ability to write and review technical documents with demonstrated high level of attention to detail. High integrity and self-motivation. Strong communication (oral and written) interpersonal and team/group interactive skills.
Physical Position Requirements
A considerable amount of time will be spent sitting / working at a computer and processing paperwork.
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 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 site or (2) via email to/from addresses using only the Zoetis domain of @. 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.Required Experience:
Unclear Seniority
Employment Type
Full-Time
