Compliance Technician - QO Regulatory Compliance, Product Release - Finished Goods

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:

$500 Sign on Bonus!

Great Health Benefits from day 1!

4 weeks accrued paid vacation and 13 paid holidays.

401(k) match with company profit sharing

Tuition reimbursement

Position Summary

Under minimal supervision, perform assigned tasks supporting multiple functional areas within Regulatory Compliance - Product Release to a very high degree of accuracy and detail. Interact with Zoetis's internal customers and external customers. Receive samples from manufacturing, distribute samples to laboratories, and submit samples to regulatory agencies. Complete cGMP documentation ensuring the data is attributable, legible (permanent), contemporaneous, original, and accurate (ALCOA). Provide input on issues within their area of responsibility to management for resolution and/or improvements. Perform all associated SAP transactions as part of the release and archive management processes.

Hours: 1st shift. Periodic weekend work and off-shift work may be required.

Position Responsibilities

Finished Good Release Support

• Sample Distribution:

• Pick up and distribute Pharmaceutical and Biological product samples to testing laboratories.

• Utilize electronic Laboratory Information System to log product samples and initiate testing work lists.

• Coordinate Lincoln, VMRD, White Hall, and Charles City sample receipts, logging samples into LIMS and distributing for testing.

• APHIS authorized sampler.

• Prepare documentation and package samples for government submission.

• Product Release:

• Complete country-specific requirements associated with product release including, but not limited to preparation of Cover Letters, Completion of China Forms, Providing Korea with Testing Records, and fulfilling Japan SLP Data requests.

Archive Cage Administration Support

• Manage and maintain Biological and Pharmaceutical sample archive areas.

• Receive/check in shipments of archive samples from Kalamazoo and Sonic.

• Annual Visual Inspection of Archive Samples.

• Destruction of Archive Samples.

• Perform associated SAP transactions, as needed.

• Support LIMS team developing Sampling Drawing Procedures to ensure adequate sample quantities for testing, archiving, and stability.

Department Support

• Provide input on issues to management for resolution and/or improvements.

• Make identified edits to department Standard Operating Procedures and route for department approval using an electronic documentation system.

Education and Experience

• Associate or bachelor's degree preferred, with communication and math skills corresponding to level of education.

• Minimum

• High School Diploma or equivalent:

• For the GJL 020-1 level

• 1-3 years of progressive experience at the OTE level in Manufacturing or Quality Operations

• For the GJL 020-2 level

• 4-6 years' experience at the OTE level in Manufacturing or Quality Operations.

• For the GJL 030-1 level

• Greater than 6 years' experience at the OTE level in Manufacturing or Quality Operations.

Technical Skills and Competencies Required

• Knowledge of APHIS/USDA/FDA/EU regulatory requirements associated with the testing and manufacturing of veterinary biological and pharmaceutical products is highly desired.

• Experience working within a GMP regulated Biotech or Pharmaceutical industry.

• Knowledge of GMP regulations for commercial manufacturing

• Ability to make independent decisions based off industry and regulations knowledge.

• High integrity and self-motivation

• Effective communication skills, written and verbal and the ability to partner and collaborate with partners from various functions.

• Highly organized and detail oriented

• Able to prioritize and multi-task in a dynamic fast paced environment.

• Experience with MS Word, Excel, Outlook, Trackwise, LIMS, Veeva Vault and SAP

Physical Position Requirement

The position has a significant amount of time spent standing/walking with some sitting when processing paperwork and/or making computer entries. Some lifting is required. Periodic weekend work and off-shift work 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.

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.