Senior Quality Control Associate - Chemistry

Job Description

Job Description

Corporate Overview

Argonaut Manufacturing Services Inc. is a leading contract development and manufacturing organization (CDMO) specializing in aseptic fill-finish services for pharmaceutical and biopharmaceutical products. Headquartered in Carlsbad, California, Argonaut supports clients from clinical development through commercial manufacturing, with a focus on product quality, yield optimization, and reliable delivery.

Argonaut provides flexible drug product manufacturing solutions, including vial, syringe, and cartridge filling, as well as combination filling capabilities. The company also offers analytical services and short-term cGMP storage to support clients throughout the manufacturing process.

With a commitment to rigorous quality standards and hands-on client support, Argonaut works closely with customers to help ensure consistent, compliant, and efficient manufacturing while meeting critical timelines and patient needs.

Benefits and Pay Range

At Argonaut Manufacturing Services we value our employees and are proud to offer a comprehensive benefits package designed to support your well-being and financial future. Eligible employees enjoy:

✔ Medical, Dental, and Vision Insurance

✔ Company-Paid Life Insurance (1x Annual Salary)

✔ Voluntary Life Insurance Options

✔ Short-Term and Long-Term Disability Insurance

✔ Flexible Spending Account (FSA) & Health Savings Account (HSA)

✔ 401(k) Retirement Plan with Company Matching

✔ 10 Days of Paid Time Off (PTO)

✔ 10 Paid Holidays Annually

The pay range for this position is $130,000 - $140,000 annually. Actual compensation will be based on factors such as location, skills, education, experience, and other relevant qualifications.

 

Position Overview

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 includes processing and testing of environmental monitoring and raw material samples. 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.

This role is an on-site position Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 7:00 am - 9:00 am with a consistent schedule.

Responsibilities and Duties

• Management of incoming samples utilizing a laboratory information system (LIMS) or other means.

• Perform detailed chemical analysis of samples from production, routine monitoring, stability and validation or qualification studies using compendial and non-compendial methods

• Utilize advanced instruments such as HPLC/UHPLC, SoloVPE, Maurice (cIEF and SDS Page), FTIR and UV/Vis Spectrophotometers

• Author protocols and reports including but not limited to, method qualification, method verification, method validation and method suitability.

• Apply and adhere to data integrity principals to sample handling and analysis

• Manage deviation/OOS investigations and implement CAPAs and change controls per GMP requirements

• Author and revise QC related SOPs as required

• Interface with product Sponsors on QC related inquiries.

• 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

• Directly contributes to daily laboratory operations for QC Chemistry in full compliance with applicable SOPs and safety guidelines

Requirements and Qualifications

• Undergraduate degree (B.A. or B.S.) in a Life Science discipline

• A minimum of 7 years' experience in a GMP-compliant Quality Control function within the medical device and/or biopharmaceutical fields

• 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)

• 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

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 will all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.

As a condition of employment, employees are required to review and sign certain company agreements and policies, including a confidential information agreement and an arbitration agreement for the resolution of employment-related disputes, in accordance with applicable law.

Background checks are conducted to support workplace productivity, safety, and security by ensuring applicant backgrounds and qualifications are suitable for the position being considered.

It is the policy of Argonaut Manufacturing Services, Inc., as part of its hiring procedures, to conduct background checks on finalist(s) for all positions. These checks will be job-related, consistent with business necessity, and conducted pursuant to all applicable laws, rules, policies, and procedures. Background checks may include, but are not limited to, verification with educational institutions or licensing/credentialing boards; standard criminal checks; employment verification; and other pertinent information and resources.

Employment offers will generally be made after successful completion of applicable background check(s). However, any offers of employment made prior to completion of the background check(s) shall be contingent upon successful completion of the check(s). Finalist(s) may be rejected if they provide inaccurate or untruthful information, do not fully participate in a required background check, or do not sign or complete a required form.