Compliance Specialist jobs in Lincoln, NE

Zoetis is the world's 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 Nebraska's Safest Companies, with a long-standing presence in Lincoln and we continue to grow.

Benefits Include:

Great Health Benefits from day 1!

4 weeks accrued paid vacation and 13 paid holidays.

401(k) match with company profit sharing

Tuition reimbursement

Student Loan Repayment Program

Position Summary

This position provides Quality Assurance support for Lincoln pharmaceutical manufacturing operations, pharmaceutical packaging, and Synovex process teams. This position is responsible for providing on-the-floor Quality Assurance support functions for pharmaceutical compounding of tablets/liquids/suspensions/pastes, and pharmaceutical packaging operations by performing real-time batch record review, quality assessments, deviation decisions and Change Control activities. This position will also interface directly with regulatory agency, customers, and internal auditors, provide support with site and department metrics. This position reports to the Team Leader Quality Assurance Operations B1/Pharma, and will work closely with Manufacturing, Materials Management / Production Scheduling, Quality Operations laboratories, Regulatory and site leadership.

Hours: 1st shift.

Position Responsibilities

• Perform routine batch record review and product release functions for assigned support areas within established timelines (e.g. at the end of the shift), ensuring compliance with all applicable regulatory requirements and product registrations.
• Support, review and approve deviation investigations, ensuring documentation meets internal and regulatory requirements, is completed within established timelines, and identifies root cause.
• Review and approve corrective / preventive actions, ensuring effectiveness of identified actions and completion within identified timelines.
• Perform line clearances within the Pharmaceutical and Synovex manufacturing and packaging areas.
• Don PAPR as required PPE for performing functions in the Synovex manufacturing and packaging areas.
• Review and approve change control for manufacturing documents and procedures, ensuring compliance with applicable regulatory standards.
• Provide QA support for product transfers and process improvement initiatives.
• Review and approve validation protocols and reports.
• Perform internal audits of manufacturing operations to ensure compliance with corporate and GMP/ regulatory requirements.
• Perform inspection readiness activities and provide QA support during Corporate and Regulatory inspections.
• Other responsibilities as assigned.

Education and Experience

Job level based on years of relevant experience:

For the GJL 040-1 level

• Associate degree
• Minimum 3-5 years of progressive experience at the OTE Lead level or above, in Manufacturing or Quality Operations

For the GJL 040-2 level

• Bachelor's degree
• Greater than 4 years' experience at an Associate Staff level position in Manufacturing or Quality Operations.

Technical Skills and Competencies Required

Minimum Qualifications:

• Investigation and Problem Solving
• Demonstrated technical capabilities.
• Ability to establish appropriate timelines to meet key milestones under minimal supervision.
• Knowledge of local, federal, and international regulations
• Knowledge of human error awareness / prevention
• Organization skills
• Verbal and written communication skills (fluent in English)
• Works effectively in a team-based environment.
• Ability to communicate effectively with Team Members to facilitate completion requests and review from all levels to meet all deadlines.
• Proficient in Microsoft Office applications
• Attention to detail.
• Demonstrated ability to work with internal and external colleagues.

Preferred Qualifications:

• Previous experience with methods in manufacturing of biologicals and protein purification
• Demonstrated knowledge of the Deviation (ETS), Change Control (ETS), ERP (SAP) and Laboratory Information Management (LIMS) systems.
• Experience in change management processes, manufacturing operations, quality operations, and/or regulatory affairs.
• Previous experience with batch record review, process deviation investigations, and change control.

Physical Position Requirement

• Lift materials up to 40lbs
• Ability to sit, stand and walk.
• Some travel may be required.

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.