Quality Specialist – Swing Shift
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
Argonaut Manufacturing Services has an immediate opening for a Quality Specialist. This role will be responsible for the Administration of Argonaut’s electronic Quality Management System (eQMS), MasterControl and will serve as the Training Coordinator. The position will report to the Director of Quality Assurance. This is a high-demand, fast paced work environment. We offer competitive salary, benefits and equity participation. We are looking for an energetic, hands-on, knowledgeable problem solver.
- Act as the Administrator for MasterControl. Troubleshoot problems, risk assessment and validation of annual upgrade of system, operate as Subject Matter Expert (SME) for software system. Ensure new employees are accurately set up in system and train new employees on the software
- Effective implementation and validation of new MasterControl modules
- Oversee and maintain Argonaut’s training program including new and existing employee training and training for various consultants and qualified suppliers
- Management and coordination of documents, ensuring documents are processed in a timely manner and that they are reviewed by the appropriate department
- Ensure documents within the Quality System are reviewed and updated as needed. Responsible for procedure reviews and facilitating procedure updates with process owners
- Oversee and ensure the document system maintains a robust, standardized, and effective Quality System which complies with applicable regulatory requirements
- Utilize metrics and reporting to effectively monitor processes, report on performance, drive improvement, and provide cost savings to the business
- Support customer and external audits to satisfactory outcomes, performing root cause analysis and other problem-solving activities to identify CAPA and process improvements
- Ensure audit findings are addressed and resolved, implementing, and performing document control and change control procedures
- Bachelor’s degree (or Associate Degree and additional related work experience) in pharmaceutical science, biology, chemistry or related science/IT
- Minimum 3 years of experience in quality computer system support/administration in the pharmaceutical/biopharmaceutical industry
- Working knowledge of FDA regulatory requirements as they relate to all aspects of quality systems and compliance
- Experience in a QA role required, preferably with a pharmaceutical or medical device company
- eQMS Administrator experience, MasterControl is preferable
- Attention to detail and disciplined in execution
- Excellent written and verbal skills required
- Experience in QA in a cGMP (21 CFR Part 210 and 211) and ISO13485 production environment
- Good documentation practices
- Strong interpersonal skills and the ability to work with and lead cross-functional teams under strict timelines
- Excellent problem solving / troubleshooting skills and the ability to analyze and interpret data to make business-critical decisions
- Strong initiative and willingness to take ownership and drive projects to completion
- Ability to effectively work independently and also in a team-based environment
- Capable of serving as a subject matter expert for eQMS and training during varied audits by customers and regulatory bodies
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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