Senior Quality Control Associate - Chemistry

Argonaut Manufacturing Services Inc.; Carlsbad (CA); On-site; USD 130,000 - 140,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Company-Paid Life Insurance

Disability Insurance

FSA/HSA

401(k) with company match

Paid Time Off

Paid Holidays

Job summary

Argonaut Manufacturing Services, Inc. in Carlsbad, CA, seeks an experienced QC Analyst to perform in-process, finished product, and stability testing in a GMP environment.

You will manage samples with LIMS and execute analyses using HPLC/UHPLC, FTIR, and UV/Vis, contributing to method validation and CAPA processes. This role reports to the Director of Quality Control and is on-site, with potential overtime.

Qualifications

• Undergraduate degree in Life Sciences required.
• Minimum 7 years’ GMP QC experience in medical device/biopharma.
• Experience with analytical methods and data integrity.
• Proficient in documenting with SOPs and reports.

Responsibilities

• Manage incoming samples using a laboratory information system (LIMS).
• Perform detailed chemical analysis of samples from production, stability, and validation studies.
• Utilize HPLC/UHPLC, cIEF/SDS-PAGE, FTIR, and UV/Vis instruments.
• Author protocols and reports including method qualification, verification, validation, and suitability.
• Apply data integrity principles to sample handling and analysis.
• Manage deviation/OOS investigations and implement CAPAs and change controls.
• Train junior personnel in lab and safety procedures.
• Interface with product sponsors on QC inquiries.
• Review and approve Manufacturing Batch Records for QC activities.
• Execute analytical method transfer activities for product-specific methods.

Skills

GMP experience

QC testing

HPLC/UHPLC

Data integrity

Documentation

Cross-functional teamwork

Safety procedures

Education

B.S. in Life Sciences

Tools

LIMS

HPLC/UHPLC

cIEF

SDS-PAGE

FTIR

Job description

Corporate Overview

Argonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 100,000 square feet of manufacturing space across four locations. 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.

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.