QC Microbiologist II

QC Microbiologist II in Hopkinton, MA Build your future at Curia, where our work has the power to save lives. The Quality Control Microbiologist II performs quality activities in support of product production and releases. The QC Microbiologist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending and reporting results. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life‑saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives. Generous benefit options (eligible first day of employment) Paid training, vacation and holidays (vacation accrual begins on first day of employment) Career advancement opportunities Education reimbursement 401K program with matching contributions Learning platform And more! Responsibilities Initiate OOS/OT or Environmental Monitoring Excursion Investigations Initiate Quality events such as deviations, invalid assay investigations, CAPA and Change controls. Perform microbiological testing (endotoxin, bioburden and TOC) for water Perform microbiological testing (endotoxin, sterility and bioburden) for raw materials, in-process materials, intermediates and final product Perform environmental monitoring of the clean rooms (under ISO and EU specifications) Read, trend and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results Prepare and send out samples for microbiological identification Maintain historical files on organisms found in classified areas; microbial identification and trending Perform line clear and line start verifications Perform other microbiological assays: Bacteriostasis and Fungistasis (B&F) Growth promotion testing of all incoming media used in the microbiology laboratory Other tests as trained and assigned Receive QC microbiological sample for internal testing, login, processing, tracking, distribution of test results, and closure Assist QC management to author, review and approve documentation. Assist QC management to perform Suite and PW system requalification. Perform compendial testing such as pH, conductivity, and Osmolality etc. Support raw material handling and testing. Provide Support of general QC Microbiology Laboratory activities, such as: Chart reading and changing Equipment cleaning and maintenance Maintaining supplies and inventory General laboratory housekeeping Qualifications Bachelor’s degree in a relevant field and a minimum of 3 years’ industry experience in a GMP, GLP, or pharmaceutical cleanroom environment, OR Master’s degree in a relevant field and 1 year of related work experience Preferred Proficient in the validation/qualification of lab microbiological techniques Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 Other Qualifications Must pass a background check Must pass a drug screen May be required to pass Occupational Health Screening Pay Range $74,000-$85,000/yr. Education, experience, location and tenure may be considered along with internal equity when job offers are extended. Curia is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Curia is an E-Verify employer. #J-18808-Ljbffr Curia, Inc.