Quality Control Associate, Microbiology

Job Description

Job Description

Corporate OverviewArgonaut Manufacturing Services Inc. is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA. 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 Benefits for this position, subject to applicable eligibility requirements.Medical Insurance Dental Insurance Vision InsuranceCompany Paid Life Insurance 1X annual SalaryVoluntary Life InsuranceLong-Term Disability Insurance and Short-Term Disability Insurance Flexible Spending Account and Health Saving Account 401(K) Retirement Plan 10 Days of Paid Time Off10 Paid Holidays Annually The pay range for this position is between $27.00 - $32.00 per hour. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.Position and ScopeThe purpose of this position is to assist in establishing and managing a microbiology program that oversees aseptic fill/finish activities, environmental monitoring, gowning qualification, and the establishment of compendial microbiology assays that include endotoxin, bioburden, and sterility. The position is responsible for ensuring all activities are performed within an appropriate level of cGMP compliance. Previous experience with aseptic filling operations and controls and drug product process validation is highly desired.This role is 100% On-Site, Monday – Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 6:00am and 9:00am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance. Responsibilities and DutiesServe as a subject matter expert (SME) for Microbiological assays and methods during internal/external audits, risk assessments, investigations, and client visits Supports assay transfer, qualification, and validation activities for microbial based assays or clients' specific methodsAuthor, revise, and review Quality Control (QC) standard operating procedures (SOPs) and assay qualification protocols and reportsPerform analysis on in-process samples, APIs, raw materials, and stability samples using existing methodsPerform routine and non-routine environmental monitoring (EM) of GMP and GLP manufacturing facilities for total particulates, air viables, and surface viables.Initiate and participate in the investigation of environmental monitoring excursions and assesses potential impact on product qualitySupport a Gowning Qualification Program for all manufacturing and QC personnelPerform routine monitoring of pharmaceutical water and gas systemsPerform Bioburden, Growth Promotion, Endotoxin, Gram Stain, Microscopy, TOC, Conductivity, and Nitrates testingMaintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activitiesAssist in trending EM data and generate quarterly and yearly reportsParticipate in inspection readiness activitiesInteract closely with other departments to ensure efficient, compliant, and timely execution of project activitiesProvide assistance as needed to maintain a functioning QC Laboratory, including material ordering, inventory control, general housekeeping, and other dutiesAssist in investigation and review of GMP quality events, including but not limited to deviations, non-conformances, and audit findingsOperate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a client driven focusSafely operate laboratory equipment in accordance to established practices and SOPsAssist in training of additional team membersUnder minimum supervision, support special projects as neededOperates to the highest ethical and moral standards. Adheres to quality standards set by regulations and Argonaut Manufacturing Services policies and proceduresCommunicates effectively with supervisors, staff, and clientsParticipate in projects within a team and as an individualSupport continuous improvement projects related to QCMulti-task, prioritize workload, document properly and interpret data accurately Follow laboratory safety requirements to promote a safety-first cultureRequirements and QualificationsCombination of Undergraduate courses and on-the-job experience in Microbiology or a related discipline (e.g., biology, chemistry, or biological sciences)Minimum three (3) years' experience in Quality Control and environmental monitoring of GMP facilitiesHigh intelligence and problem-solving skills Excellent oral and written communication and listening skills High level of personal and professional integrity and trustworthiness with a strong work ethic and the ability to work independently with minimal direction Experience in a growth-oriented, cGMP contract manufacturing organization with a focus on compliant execution of business is preferredGeneral knowledge of one or more of compendial methods such as: Bioburden, Endotoxin, Growth Promotion, Sterility, and other microbiological methodsKnowledge in environmental excursion investigations, root cause analysis, out of specifications, and knowledge of cleanroom practices is preferredDirect experience with endotoxin, bioburden, and growth promotion methodologies. Experience in sterility testing is highly desired.Experience with transfers and qualification/validations of large molecule focused analytical methodsMust have experience with Microsoft Office applications Experience with quality software and 21 CFR 11 applications preferred 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.