Senior Quality Control Associate - Chemistry

Job Description

Job DescriptionCorporate OverviewArgonaut 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 RangeAt 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 OverviewThe 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 DutiesManagement 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 methodsUtilize advanced instruments such as HPLC/UHPLC, SoloVPE, Maurice (cIEF and SDS Page), FTIR and UV/Vis SpectrophotometersAuthor 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 analysisManage deviation/OOS investigations and implement CAPAs and change controls per GMP requirementsAuthor and revise QC related SOPs as requiredInterface with product Sponsors on QC related inquiries.Participate in the review and approval of Manufacturing Batch Records for QC related activitiesExecute analytical method transfer activities, including product-specific test methodsTrain junior personnel in appropriate laboratory and safety proceduresExecute Installation and Operational Qualification of analytical instrumentation where applicableDirectly contributes to daily laboratory operations for QC Chemistry in full compliance with applicable SOPs and safety guidelinesRequirements and QualificationsUndergraduate degree (B.A. or B.S.) in a Life Science disciplineA minimum of 7 years' experience in a GMP-compliant Quality Control function within the medical device and/or biopharmaceutical fieldsA high level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal directionAnalytical 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 ManagementAn affinity for precise and detailed documentation skills. The ability to effectively influence and contribute to a dynamic and fast-paced work environmentA strong work ethic and a high level of accountabilityStrong oral and written communication and listening skillsExcellent Problem-solving skillsArgonaut 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.