GMP Training Lead

What is it like to work for Zoetis, the world leader in animal health? Zoetis means something a little different to every colleague, but at our core, our purpose 'to nurture the world and humankind by advancing care for animals' is what unites us in all our roles.

We are a global animal health company dedicated to serving veterinarians, livestock producers and people who raise and care for farm and companion animals in more than one hundred countries. And we are excited to become a part of the Lithia Springs, GA, community as we build our newest manufacturing facility to support our growing monoclonal antibody and vaccine portfolios.


We are currently searching for a GMP Training Lead to join our team.

Job Description:

This position is the process owner for GMP training at the site. The lead will develop and deliver cGMP and cGDP training, as well as support training development regarding contamination control and aseptic behavior as they relate to aseptic manufacture, filling, and packaging of biological and biopharma drug products. Designs, develops, implements curricula, and conducts training in compliance with site procedures and global standards. Identify and drive continuous process improvements related to GMP and aseptic training. Continuously improve and innovate training execution and management, conduct audits/reviews of personnel to evaluate training effectiveness. Makes decisions that are in accordance with company policies and SOPs, Core Values, and global regulatory guidelines (including cGMP/cGDP/cGLP), environmental guidelines.

Position Responsibility:

• Provide flexible training support across all identified functions, delivering startup-to-full-operations training and assuming responsibility for additional training needs as they arise.
• Learning Management System administration (SAP SuccessFactors)
• Facilitate New Employee Orientation (including cGMP/cGDP/cGLP), and aseptic training for initial and refresher training for site personnel, including gowning qualification and classroom process simulations.
• Coordinates required annual training requirements with department management.
• Conducts spot checks/audits of aseptic techniques and behaviors during operations.
• Observes aseptic process simulations (media fills) for aseptic practices and best practices.
• Network with the Global Aseptic Team to share best practices.
• Liaison with colleagues to ensure training and understanding of the critical aseptic processing that they are conducting.
• Coordinates personnel training using available technology, including, but not limited to, virtual reality technology.
• Integrates training sessions and training documentation into electronic training document management systems.
• Collaborate with area Operations Team Leaders to train and lead colleagues in the performance of best practices.
• Collaborate with QC to analyze training techniques and instructions for error prone testing.
• Collaborate with QA to analyze training techniques and instructions for incidents with patterns and trends.
• Utilize subject matter knowledge related to drug product manufacturing, filling, and packaging in the development of training:
  • GMP/Regulatory Requirements
    • Compliance Trends and Data Integrity
    • Basic Industrial Microbiology
    • Types of Microorganisms
    • Growth and Reproduction
    • Sources of Cleanroom Contamination
    • Reduction/Elimination
    • Measurement Systems
    • Site Specific Data Trends and Metrics
  • Facility Design / Environmental Controls
    • Cleaning and Disinfection (facility surfaces, equipment)
    • Aseptic and Controlled Area Gowning
    • Aseptic Training / Good Aseptic Technique
    • Material Transfer
    • Material/Personnel / Equipment Flow and Movement
    • Use of Isolator and Barrier Systems
    • Sterilization / Validation
    • Bioburden Reduction

Education and Experience:

• BS (minimum) with 8+ years of experience related to pharmaceutical manufacturing and packaging.
• Bachelor's degree in engineering, biology, chemistry, microbiology, virology, immunology, or related technical field.
• Must have strong technical/analytical skills and possess a high degree of personal motivation.
• Excellent people skills and ability to interact across divisional boundaries.

Technical Skills Requirements:

• Strong technical/analytical skills and possess a high degree of personal motivation.
• Strong presentation and presentation development skills.
• Excellent people skills and ability to interact across divisional boundaries.
• Familiar/proficient in adult learning methodologies.
• Strong technical writing skills.
• Working knowledge of pharmaceutical production methods and cGMP experience.
• Knowledge of FDA, APHIS, VMD, USDA regulations applicable to the Pharmaceutical/Biological industry.
• Preferred experience in aseptic and biological product formulation (blend/fill/lyophilization), packaging, and/or testing.
• Preferred experience in Lean/Six Sigma.

Physical Requirements:

• Able to walk or stand for extended periods of time.
• Able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
• Able to work scheduled 40 hours with the ability to work overtime as needed.
• Frequent lifting and carrying of 5 to 25 lbs.
• Regular reaching, bending, stooping, and twisting.
• Repetitive motion and substantial movement of the wrists, hands, and/or fingers
• Able to become qualified to enter clean room environment.
• Work Environment: While performing the duties of this job, the employee occasionally works in clean room environments. The noise of these work environments is typical office noise.

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 @zoetis.com 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 @zoetis.com , 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 View email address on click.appcast.io 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 "@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.