Assists and supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. Performs trending of internal controls and risk assessments. Responsible for the maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.
Serve as a team member technical resource for problem investigations to guide root cause analysis and corrective action development. Investigate assigned CAPAs, Complaints, and NCMRs to root cause, ensuring that appropriate corrective and preventive action is taken for effective closure to issue. Participate in product improvements/manufacturing investigations
Develop test methodologies and document validation/verification for equipment, methods and/or instrumentation associated with parts and materials QC. Help determine the appropriate sampling plans and measurements for reagent formulation production and help monitor performance and identify potential emerging issues.
Completes monitoring and trending to proactively identify emerging issues and contribute to continuous improvements within Quality and Manufacturing. Notification to manager and Quality management of emerging issues
Demonstrate appropriate professional communication when interfacing with production personnel to help determine root cause and work towards process improvements.
Process ERP transactions to segregate and disposition non-conforming product.
Assist with developing, reviewing and improving procedures and processes related to product quality.
Assist with internal and external audits.
Other duties and responsibilities in the Quality Department as assigned
Support and participate in MRB for product review, control and disposition
Monitor NCMRs for developing trends and reports, and address quality issues proactively and escalate issues to CAPA as appropriate.
Develop/improve Incoming QC specifications (inspection criteria and sampling plans); work with QC Technicians in maintaining flow to incoming materials to meet production demand
Actively participate in the Validation Program
Review and approve validation protocols and reports.
Ensure robust equipment qualifications, and product and process validations.
Support to validation teams to achieve project milestones.
Support to validation teams for documenting process risk analyses.
Serve as in-house expert for Process Validation, equipment qualification, and process risk analysis (pFMEA).
Support with the development of Validation protocols and reports for automation equipment software, test systems, spreadsheets, etc.
As QA representative, participate effectively in product development activities, including Design Reviews and Risk Management. Review and approve Design History File (DHF) documents and ensure compliance to Design Control requirements.
Education and Experience:
BS in Chemistry with relevant experience. Three years of experience in an FDA regulated environment in the medical device industry and/or in-vitro diagnostics preferred.
Knowledge and experience with GMP and Good Documentation Practices required
Knowledge or experience in ISO 14971: 2019 Risk Management Principles required
ASQE certification Preferred
Strong attention to details and ability to understand and follow complex procedures.
Strong technical skills including statistical techniquest
Sound working knowledge of regulations pertaining to QA and related compliance requirements.
Working knowledge and experience in basic computer applications such as Microsoft Word, Excel and Outlook. Experience in Visio is a plus
Effective and clear written and verbal communication skills.
Strong decision making skills and ability to meet project timelines
Lyophilization experience preferred
Change and Learning Agility : Able to quickly analyze and solves problems by applying an analytical, data drive and experimental mindset and seeks to understand both successes and failures to improve and develop.
Collaborates with others : Exhibits strong self-awareness and is open to feedback
Acts decisively with good judgment : Makes sound and timely decisions on an informed basis, in good faith in the best interest of the company.Full timeRegularColleagueZoetis 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 [Register to View] 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 [Register to View] 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.