Quality Program Coordinator
Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. The company is dedicated to serving highly innovative companies in the biopharmaceutical and molecular diagnostics industries. Argonaut is a full service, cost-effective partner, providing complete solutions in the areas of formulation, filling and final kitting of reagents and consumables. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.
Position and Scope
The Quality Program Coordinator will manage quality events such as Nonconformances, CAPAs, and Deviations. The role is a key Quality contact and requires the ability to independently manage timelines and effectively communicate with team members, cross-functional stakeholders, and clients while helping to maintain site Quality Systems in a state of inspection readiness.
The Quality Program Coordinator will conduct GMP investigations including root cause analysis, facilitate and lead Material Review Board meetings, create quality metrics, and conduct investigations. This is a high demand, fast paced work environment.
- Support the creation, review, approval, execution, extension, and/or closure of Nonconformances, Deviations, CAPAs, and Complaints
- Assist other departments to successfully investigate and document investigations
- Complete accurate and thorough historical searches within quality system to identify similar events and determine trends
- Lead quality training sessions as needed
- Act as an SME on quality system processes, e.g., CAPA, Nonconformances, etc.
- Participate in process improvements associated with investigations
- Complete, review, and/or approve quality documents
- Other duties as assigned
- Superior attention to detail, organizational skills, and the ability to multi-task in a time-line driven environment
- Experience working in the life science and/or pharmaceutical manufacturing industry
- Proven problem-solving skills
- Excellent oral and written communication skills, and listening skills
- Working knowledge of cGMP regulations, 21 CFR 820, ISO 13485, and good documentation practices
- Ability to make decisions regarding quality of product and material
- Strong initiative and willingness to take ownership and drive projects to completion
- Bachelor’s degree is strongly preferred in a Life Sciences discipline or equivalent
- Minimum five (5) years of relevant experience
- Must be able to effectively communicate within the department and cross-functionally with other divisions
- High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction
- Experience with MasterControl and NetSuite a plus
Argonaut Manufacturing Services, Inc. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies with all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.
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