Senior Quality Control Associate
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. In July of 2018, Argonaut acquired LyoGen, a leader in dose specific lyophilization capabilities for the diagnostics markets. Argonaut provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.
Position and Scope
The purpose of this position is to provide support services by means of executing the analysis of in-process, finished product and stability test samples. Further support services include Environmental Monitoring and Raw Material receipt activities. QC personnel are responsible for compliance to QC policies and procedures within the QC laboratory, company policies, and cGMP guidelines. This position will report to the Director, Quality Control.
- Directly contributes to daily laboratory operations for QC Chemistry and Microbiology, in full compliance with applicable SOPs and safety guidelines
- Analyzes on a routine basis in-process, release, and stability test samples in accordance with established QC test methods and specifications
- Monitors EM samples for the cleanrooms and associated production facilities per established company procedures
The successful candidate will:
- Manage incoming inspection of raw materials in accordance with company policy and procedures
- Participate in environmental monitoring for the facility on a routine basis per applicable SOPs including sampling of the USP Purified Water system, Clean Compressed Air, Nitrogen and Clean Steam
- Manage deviation/OOS investigations and implement CAPAs and change controls per GMP requirements
- Author and revise QC related SOPs as required
- Participate in the review and approval of Manufacturing Batch Records for QC related activities
- Execute analytical method transfer activities, including product-specific test methods.
- Train junior personnel in appropriate laboratory and safety procedures
- Execute Installation and Operational Qualification of analytical instrumentation where applicable
Position Requirements and Experience
The desired candidate will have:
- 5+ years GMP experience in a Quality Control function within the medical device and/or biopharmaceutical fields
- The ability to work effectively within cross functional teams comprised of Manufacturing, Tech Transfer, Quality Assurance, and Senior Management
- An affinity for precise and detailed documentation skills
- The ability to effectively influence and contribute to a dynamic and fast-paced work environment
- A strong work ethic and a high level of accountability
- Strong oral and written communication and listening skills
- Excellent Problem-solving skills
- Undergraduate degree (B.A. or B.S.) in a Life Science discipline
- A minimum of 5 years’ experience in a GMP-compliant Quality Control function
- A high level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction
- Analytical experience in the following methodologies: Buffer Characterization (pH, conductivity, osmolality), Concentration (UV/Vis and/or Fluorescence), Chromatography (HPLC, Electrophoresis)
- qPCR and Microbiology experience is preferred
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.