Quality Assurance Assistant
Argonaut Manufacturing Services, Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA, 25 miles north of downtown San Diego. The company is dedicated to serving highly innovative companies in the biopharmaceutical and human diagnostics industries. Argonaut is a full service, cost effective partner, providing complete solutions in the areas of formulation, filling and finishing, and final kitting. Argonaut also provides the quality and regulatory expertise to assure the highest in quality manufacturing.
Position and Scope
Argonaut Manufacturing Services has an immediate opening for a Quality Assurance Assistant. This role will be responsible for lot/batch release of incoming materials and final product. Management and coordination of documents (including SOPs, specifications, reports, etc.), through Argonaut’s eQMS (MasterControl) and ERP system (NetSuite) are a daily activity. The individual will be responsible for supplier management. This position will also be responsible for supporting customer and external audits to satisfactory outcomes, performing root cause analysis and other problem-solving activities to identify CAPA and process improvements. The individual will help support Argonaut’s transition to an FDA CFR Part 210 & 211 environment.
The individual will support the QA department in ensuring that audit findings are addressed and resolved, addressing non-conformances in manufacturing, implementing and performing document control and change control procedures, CAPA, tracking and trending. 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. Working knowledge of the following skills is required:
- eQMS systems including MasterControl.
- ERP system proficiency.
- Attention to detail and disciplined in execution.
- Excellent written and verbal communication skills.
- Experience in QA in a cGMP and ISO 13485 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 work independently and also 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).
- Experience in a QA role is a plus.
- Must be proficient in Word.
- Excellent verbal and written communication skills.
- Science background preferred, but not necessary.
- MasterControl and/or NetSuite knowledge extremely helpful.
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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