Quality Assurance Associate

Argonaut Manufacturing Services has an immediate opening for a Quality Assurance Associate. The role will be responsible for releasing batch records, creating, and revising technical documents (including SOPs, specifications, reports, etc.), as well as driving the resolution of product quality customer complaints and internal non-conformance events. The position will report to the Director of Quality Assurance. We are looking for an energetic, hands-on knowledgeable problem solver. We offer competitive salary, benefits, and equity participation.

Responsibilities

  • Support customer and external audits to satisfactory outcomes
  • Perform root cause analysis and other problem-solving activities to identify CAPA and process improvements
  • Support the QA department in ensuring that audit findings are addressed and resolved
  • Address non-conformances in manufacturing
  • Implement and perform document control and change control procedures, CAPA, tracking and trending

Requirements

  • BS/BA degree and three years experience in a QA role, preferably within the medical device¬† or pharmaceutical industry
  • Effective communication skills with internal and external customers, both verbal and written
  • Batch production record review experience in a medical devise or pharmaceutical industry,¬† a plus
  • Experience with deviations and non-conformance material reports
  • Experience with root cause investigative techniques
  • Experience with product transfers or new product implementations (R&D to GMP)
  • QA materials release experience
  • eQMS systems experience including MasterControl
  • Experience in Life Science QA in a cGMP 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
  • Attention to detail and disciplined in execution
  • Strong initiative and willingness to take ownership and drive projects to completion
  • Ability to work independently and in a team-based environment effectively
  • Ability to create and revise manufacturing documentation, processing documents, SOPs, manufacturing pilot plans, etc.
  • Capable of serving as a subject matter expert for manufacturing during varied audits by customers and regulatory bodies
  • Advise the manager of factors that may affect quality of the product, initiate problem reports for deviations and non-conforming materials, and provide guidance/options and ideas for corrective actions and preventive actions (CAPA)

Preferred Qualifications

  • Hands-on experience in QA/QC required with participation in audits (performing, conducting, participating) with large Life Science of medical device company
  • Organized, responsible, and dependable
  • Knowledge in lab space layout and design from a Lean Manufacturing perspective, a plus
  • Experience following standard operating procedures and recording data extemporaneously in batch documentation while following good documentation practices

Additional Qualifications (nice to have to support manufacturing)

  • Proven knowledge in process validation
  • Experienced in the use LIMS for manufacturing applications
  • ERP implementation and operational experience
  • Working knowledge of 5S and Lean Manufacturing Principles

Corporate Overview

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 the quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

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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