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.
We proudly offer
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
Pay Range: $74,000-$85,000/yr.
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. 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.
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