Argonaut Manufacturing Services Inc.
Senior Quality Control Associate - Chemistry
Argonaut Manufacturing Services Inc., Carlsbad, California, United States, 92002
Senior Quality Control Associate - Chemistry
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Pay Base pay range: $130,000.00/yr - $140,000.00/yr
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 serves biopharmaceutical and molecular diagnostics industries with full service formulation, filling and final kitting of reagents and consumables. The role supports the analysis of in-process, finished product and stability test samples, and environmental monitoring and raw material samples. The position reports to the Director, Quality Control and is on-site Monday to Friday, with potential Overtime, weekends and holidays.
Responsibilities And Duties
Manage incoming samples utilizing a laboratory information system (LIMS) or comparable system.
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 method qualification, method verification, method validation and method suitability.
Apply and adhere to data integrity principles in 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.
Contribute to daily laboratory operations for QC Chemistry in full compliance with SOPs and safety guidelines.
Requirements And Qualifications
Undergraduate degree (B.A. or B.S.) in a Life Science discipline.
Minimum of 7 years' experience in a GMP-compliant Quality Control function within the medical device and/or biopharmaceutical fields.
Integrity and ability to work independently with minimal direction.
Analytical experience in Buffer Characterization (pH, conductivity, osmolality), Concentration (UV/Vis and/or Fluorescence), and Chromatography (HPLC, Electrophoresis).
Ability to work effectively within cross-functional teams (Manufacturing, Tech Transfer, Quality Assurance, and Senior Management).
Strong documentation skills and attention to detail.
Ability to thrive in a dynamic, fast-paced environment with accountability and strong work ethic.
Strong oral and written communication and problem-solving skills.
Benefits
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
14 Days of Paid Time Off (PTO)
10 Paid Holidays Annually
Compliance Argonaut Manufacturing Services, Inc. is an equal opportunity employer committed to providing employment opportunities without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by law. Background checks may be conducted for finalist candidates as part of the hiring process and may include verification with educational institutions or licensing boards, criminal checks, and employment verification. Employment offers are contingent upon successful completion of applicable background checks.
Employment Details Employment type: Full-time
Seniority level: Mid-Senior level
Location: Carlsbad, CA (on-site)
Compensation: Base pay $130,000 - $140,000 per year; actual compensation based on location, skills, education, experience, and other qualifications.
Note: This posting may include related roles and salary data for nearby locations.
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Get AI-powered advice on this job and more exclusive features.
Pay Base pay range: $130,000.00/yr - $140,000.00/yr
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 serves biopharmaceutical and molecular diagnostics industries with full service formulation, filling and final kitting of reagents and consumables. The role supports the analysis of in-process, finished product and stability test samples, and environmental monitoring and raw material samples. The position reports to the Director, Quality Control and is on-site Monday to Friday, with potential Overtime, weekends and holidays.
Responsibilities And Duties
Manage incoming samples utilizing a laboratory information system (LIMS) or comparable system.
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 method qualification, method verification, method validation and method suitability.
Apply and adhere to data integrity principles in 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.
Contribute to daily laboratory operations for QC Chemistry in full compliance with SOPs and safety guidelines.
Requirements And Qualifications
Undergraduate degree (B.A. or B.S.) in a Life Science discipline.
Minimum of 7 years' experience in a GMP-compliant Quality Control function within the medical device and/or biopharmaceutical fields.
Integrity and ability to work independently with minimal direction.
Analytical experience in Buffer Characterization (pH, conductivity, osmolality), Concentration (UV/Vis and/or Fluorescence), and Chromatography (HPLC, Electrophoresis).
Ability to work effectively within cross-functional teams (Manufacturing, Tech Transfer, Quality Assurance, and Senior Management).
Strong documentation skills and attention to detail.
Ability to thrive in a dynamic, fast-paced environment with accountability and strong work ethic.
Strong oral and written communication and problem-solving skills.
Benefits
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
14 Days of Paid Time Off (PTO)
10 Paid Holidays Annually
Compliance Argonaut Manufacturing Services, Inc. is an equal opportunity employer committed to providing employment opportunities without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by law. Background checks may be conducted for finalist candidates as part of the hiring process and may include verification with educational institutions or licensing boards, criminal checks, and employment verification. Employment offers are contingent upon successful completion of applicable background checks.
Employment Details Employment type: Full-time
Seniority level: Mid-Senior level
Location: Carlsbad, CA (on-site)
Compensation: Base pay $130,000 - $140,000 per year; actual compensation based on location, skills, education, experience, and other qualifications.
Note: This posting may include related roles and salary data for nearby locations.
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