Microbiologist III in Albuquerque, NM
Build your future at Curia, where our work has the power to save lives
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
+ 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!
Summary:
The Quality Control Microbiologist III is responsible for performing advanced microbiological testing and quality activities to support product production, environmental monitoring, and product release in a pharmaceutical manufacturing environment. This role ensures compliance with regulatory requirements and company standards by conducting microbiological assays, analyzing trends, and accurately documenting and reporting results. Additionally, the QC Microbiologist III plays a key role in conducting QC risk assessments, identifying potential microbiological risks, and troubleshooting deviations. This position collaborates with cross-functional teams to drive continuous improvement initiatives, maintain product quality, and uphold patient safety.
Essential Duties and Responsibilities:
+ Perform microbiological testing (endotoxin, sterility, and bioburden) for raw materials, in-process materials, intermediates, and final products.
+ Conduct microbiological testing (endotoxin, bioburden) for utilities such as water, steam, nitrogen, etc.
+ Perform environmental monitoring of cleanrooms in compliance with USP and EU specifications.
+ Review, trend, and report results for environmental, personnel, in-process, raw material, finished product, and utilities testing.
+ Conduct microbial characterization (gram stain, catalase, oxidase, and coagulase tests) and prepare and send out samples for microbiological identification.
+ Maintain historical files for organisms found in classified areas, including microbial identification and trending.
+ Perform line clearances and line start verifications, as well as inspections of media fills.
+ Serve as the Subject Matter Expert (SME) for microbiological assays such as sterility (including biological indicator testing) and growth promotion testing for all incoming media used in the microbiology laboratory.
+ Perform microbial limits/enumeration testing and handle QC microbiological sample receipt, including internal testing, logging, processing, tracking, distribution of test results, and closure.
+ Author and revise controlled documents, including Standard Operating Procedures (SOPs), Investigational Protocols, Risk Assessments, and others as needed.
+ Initiate Out of Specification (OOS) or Environmental Monitoring Excursion investigations, recommend appropriate Corrective and Preventive Actions (CAPAs), and complete effectiveness checks.
+ Oversee equipment cleaning and maintenance, including managing supplies and inventory.
+ Act as a liaison with vendors for maintenance, preventive maintenance (PM), and calibration of equipment.
+ Ensure general laboratory housekeeping and maintain a clean, organized workspace.
+ Facilitate the revision and release of all controlled documents in a timely manner.
+ Coordinate mandatory reviews of SOPs and month-end reports, ensuring they are completed on schedule.
+ Read/interpret SOPs to ensure compliance
+ Maintain up to date trainings
+ Other duties as assigned
Education and/or Experience:
+ Bachelor's degree in a scientific discipline, preferably microbiology or related field
+ Minimum of five (5) years related work experience
+ Minimum of three (3) years industry experience in a GMP or GLP environment, preferred
+ Previous experience with pharmaceutical cleanroom environments, preferred
+ Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485, and 17025, preferred
+ Experienced and proficient in the validation/qualification of lab microbiological techniques, preferred
Supervisory Responsibilities:
This role does not have supervisory responsibilities, yet it may involve mentoring, guiding, and advising.
Language Skills:
The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication sk