Compliance Specialist
Zoetis

Lincoln, Nebraska

Posted in Pharmaceuticals


This job has expired.

Job Info


Position Summary

Perform activities necessary maintain the Reference Qualification Program to ensure program compliance with USDA and GMP regulations, Global Quality Standards, and other applicable regulations, as well as site policies and procedures.

Position Responsibilities

PRINCIPAL JOB DUTIES: (Describe key job responsibilities required to fulfill the major purpose of the job.)

Assist/Perform raw data verification and Audit of formulation blend sheets Perform audits of analytical and clinical reports prepared for regulatory submission. Review reports to raw data, protocol and standards assuring no errors, appropriate representation of data, and compliance with Zoetis/departmental policies and procedures. Assist/Lead change control process process for reference qualifications, laboratory improvements, and department supported initiatives. Includes but is not limited to: schedules and scribes inventory management meetings, assists with Outline changes and prepares variations, with the assistance of lead analyst, researcher, or clinician, for international submissions. Establish/Maintain standard operating procedures and curriculum governing program and assure compliance with the program standards and procedures Manage the clinical & analytical data archive system to assure that all raw data and reports are appropriately archived & retrievable. Participate on key teams and task forces to address reference requalification issues and improvement projects. Complete projects assigned by senior departmental personnel within specified timelines.

Other duties may include:

Assist/Manage the reference stability monitoring timelines/activities Draft/Prepare cover letters for regulatory submission in collaboration with VMRD-RA. Assist/Prepare the Animal Care & Use Protocols (ACUPs) for the clinical & laboratory animal studies, and assure that they are approved by the Institutional Animal Care & Use Committee (IACUC) according to established timelines.

Education and Experience

B.A./B.S. in science or related degree with equivalent experience. Minimum of 5 years relevant experience. Experience with developing and maintaining raw data collection systems. General understanding of contemporary & traditional bacteriology & virology techniques, and validation principles. Understanding of basic statistical analyses used to evaluate analytical & clinical studies. 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; or DVM with applied skills in immuno-, biochemical, or molecular biological assays. Strong experience in USDA and VMD regulations with thorough knowledge of 9CFR 113.8. Prior Lean methods training and/or certified in RFT Six-sigma applications. Prior quality assurance experience regarding documentation and change control systems.

Full time

Regular

Colleague

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.

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