Job Description:
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're 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 100 countries. And we're excited to become a part of the Metro Atlanta, GA, community as we build our newest manufacturing facility to support our growing monoclonal antibody and vaccine portfolios.
We are currently searching for a Quality Control Manager to join our team.
DESCRIPTION
The QC Manager/TL will have overall responsibility to manage and control all QC activities in support of the site's initial mAbs Bio-packaging Operations and future Biological and Pharmaceutical Operations. Leading all QC activities in accordance with identified Global Zoetis Quality Systems and Standards as well as all relevant regulatory and legislative regulations across the lifecycle of the Site products.
Direct and oversee analytical activities by providing a Fit for Purpose and Safe working environment in which all equipment and methods are in a validated state and compliant with applicable regulations. Management of the Lab operations include Testing Management of all Site Materials, Raw Materials, In process and Finished Product Samples, Stability Testing, House Retains, Environmental Monitoring, Utilities, and Microbial testing. Lab management also includes maintenance of laboratory materials necessary to perform testing, maintaining laboratory data integrity, and overseeing laboratory investigations.
(Near-term) Responsibilities in a Startup Environment: In a startup environment, the Quality Control Manager will adapt quickly to changes, lead in developing and optimizing new processes, and identify opportunities for innovation and improvement. This role involves close collaboration with cross-functional teams, managing inventory and resources efficiently, and troubleshooting unexpected challenges. You will also contribute to scaling Lab processes and Method Transfers, participate in diverse tasks to support the dynamic needs of the startup, and ensure the sustainability and scalability of all procedures as the company grows. Specific activities would include FAT, SAT, CQV, media and engineering runs that lead to stability batches. The successful candidate will need to be flexible to perform activities outside of the standard Quality Control requirements to assist other departments during scale up of staffing and processes.
KEY RESPONSIBILITIES INCLUDE:
Management of Lab Operations
- Daily batch report review and approval
- External lab management
- 3rd party lab result data entry
- OOS trending and reporting
- Stability testing
- Environmental Monitoring
- Internal Sample Management
- Internal testing
- Laboratory supplies
Internal Lab Management
- Obtain testing and retention samples from bulk containers of raw ingredients and finished products.
- Maintain accurate records of all testing performed in a manner consistent with cGMP regulations.
- Ensure laboratory equipment is maintained and calibrated according to the maintenance schedule.
- Assures that products conform to established specifications of purity, quality, and composition.
Standardized Testing
- Works with support of the Site Quality Leader to establish in-house assay methods and criteria for assays from independent laboratories.
- Keep all product file information current and up to date.
- Makes recommendations to improve Product Quality/Product Assurance/cGMP standards.
- Create relevant and appropriate laboratory SOPs.
- Create various specification documents.
- Assist with various activities relating to regulatory compliance.
- Reviewing, testing, and approving Finished, WIP, and raw materials for use and their associated batch reports.
- Sampling of raw materials in accordance with cGMPs, as they are received in warehouse.
- Maintaining all documents associated with FDA, USDA, EMA and cGMP compliance.
- Other QA/QC related tasks
Staff and Leadership Responsibilities
- Stewardship of the Quality Culture within the Quality Operations Function as well as the Site.
- Support the development of Quality goals and targets as part of the organization's strategic plan.
EDUCATION and EXPERIENCE
- Bachelor of Science, Biological sciences, Chemistry, or other related sciences.
- Demonstrated knowledge of compliance, quality and scientific principles in an FDA regulated environment is required.
- Environmental Monitoring experience preferred.
- Minimum of 5 years progressive experience in Quality Control.
- Preferred: 3 or more years of leadership experience.
- Detailed knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (cGMP).
- Lean Labs Qualification is desirable.
TECHNICAL SKILLS and COMPETENCIES REQUIRED
- Fluency in quality systems and regulatory compliance.
- Driven / Passionate about Quality performance and delivering results.
- Must be well-organized, detail oriented, and able to work within deadlines as well as under pressure.
- Exercises Good Judgment and Drives Change- using appropriate influence techniques.
- Strong written and oral communication skills as well as negotiation skills.
- Confident decision maker, self-accountability with an ability to develop and adhere to self-directed standard work.
- Drives for Superior Results.
- Inspires Continuous Improvement and Breakthrough Thinking - utilizing problem solving tools such as Lean and Six Sigma.
- Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with Quality and Business objectives.
- Fluent in English (written and spoken).
- Demonstrated written communication skills, as well as experience with presenting to leadership teams.
- Business Fluency and awareness and Ability to be a trusted partner.
PHYSICAL POSITION REQUIREMENTS
- This is full time position based at the Site.
- This position will require fluent use of teleconferencing tools, as well as SharePoint technologies and MS Office tools, to share and manage information
Note: This description indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required. Additional position specific requirements/responsibilities are contained in approved training curricula.
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.
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