Quality Assurance Compliance Specialist

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

This position provides Quality Assurance support for Lincoln manufacturing operations supporting the biological and biopharmaceutical manufacturing process teams. This position is responsible for providing on-the-floor Quality Assurance support functions for antigen and monoclonal antibody production by performing for 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 and provide support with site and department metrics. This position reports to the B2 Quality Assurance Team Lead 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.
• 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

• Associates degree
• Minimum 3-5 years of progressive experience at the OTE Lead level or above in Manufacturing or Quality Operations
• Bachelors 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 manufacturing methods for antigen production media preparation or monoclonal antibody processes.
• 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 Requirements

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

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.

Notice: Zoetis Recruiters will contact candidates via email from an address ending in @ and may also initially connect with candidates through LinkedIn including LinkedIn InMail. Zoetis does not use Gmail Outlook Yahoo or other web-based/generic email domains to communicate about job opportunities interviews or offers of employment. If you receive a recruitment-related email message claiming to be from Zoetis that does not come from @ please treat it as suspicious. For your security do not reply click links open attachments share personal or financial information or send money in response to unexpected or questionable recruitment communications.

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 addition Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.