Job Summary:

The Laboratory Analyst is responsible for performing routine and advanced analytical and microbiological testing to support the manufacture, release, and ongoing quality of sterile drug products produced in a 503B outsourcing facility. The Analyst executes compendia! methods following United States Pharmacopeia (USP) requirements, including but not limited to USP <71> Sterility Tests, USP <61> Microbial Enumeration, USP <791> pH, USP <785> Osmolality, USP <788> Particulate Matter, and USP <790> Visible Particulates. Additional responsibilities include organism identification, environmental monitoring support, data analysis, equipment usage, and strict adherence to all Standard Operating Procedures (SOPs), and GxP regulations.

The role requires exceptional attention to detail, technical proficiency, strong documentation practices, and the ability to work efficiently in a fast-paced and highly regulated sterile manufacturing environment.

Responsibilities:

• Analytical and Microbiological Testing
• Perform compendia I testing on raw materials, in-process samples, and finished drug products, including but not limited to USP <71>, <61>, <791>, <785>, <788>, and <790>.
• Conduct microorganism identification using phenotypic platforms (e.g., MALDI-TOF)
• Perform growth promotion tests, media qualifications, and sterility qualifications as required.
• Execute method suitability and method verification activities according to SOPs and regulatory guidance.
• Support environmental monitoring (EM) investigations by analyzing isolates and trends.
• Prepare media, reagents, dilutions, and controls as needed for routine testing.
• Other duties as assigned.
• Data Review, Documentation & Compliance
• Record all testing activities in accordance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).
• Analyze and interpret data, ensuring results meet specifications and cGMP expectations.
• Report atypical, out-of-specification (OOS), and out-of-trend (OOT) results promptly and assist in laboratory investigations.
• Follow all SOPs, test methods, and work instructions without deviation unless approved through the change control process.
• Maintain accurate instrument logs, calibration records, and laboratory notebooks.
• Support quality audits and regulatory inspections as needed.
• Equipment Operation & Maintenance
• Operate laboratory instruments such as micro-osmometers (e.g., OsmoTECH Pro), pH meters, microscopes, particle counters, TOC meters (if applicable), and microbiology identification systems.
• Perform routine instrument calibrations, verifications, and daily system suitability checks.
• Document equipment usage and maintenance activities.
• Troubleshoot basic issues and escalate instrumentation problems to supervisors, quality, or engineering.
• Quality, Safety & Continuous Improvement
• Maintain a clean, organized, and compliant laboratory workspace, including adherence to aseptic techniques and contamination control practices.
• Comply with all laboratory safety policies, including proper PPE use and handling of hazardous materials.
• Participate in continuous improvement initiatives, CAPAs, and cross-functional projects.
• Provide training to new analysts, as qualified.
• Required Skills/ Abilities:
• Excellent verbal and written communication skills.
• Attention to Detail: Ensures accuracy in testing, data entry, and documentation.
• Technical Proficiency: Able to execute complex laboratory methods with minimal supervision.
• Problem Solving: Identifies issues promptly and contributes to laboratory investigations.
• Communication: Clearly documents findings and communicates issues to management.
• Teamwork: Collaborates effectively in a cross-functional environment.
• Compliance Mindset: Demonstrates strong cGMP ethics and commitment to data integrity and impartiality.

Education and Experience:

• Bachelor's degree in Microbiology, Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline.
• 3+ years of laboratory experience in a regulated environment (503B, 503A, CGMP, Pharmaceutical QC, GLP, or similar) preferred.
• Working knowledge of USP compendia! methods for sterile products.
• Strong understanding of aseptic technique and contamination control.
• Proficiency in Microsoft Office, LIMS/ELN platforms, and data entry.

Physical Requirements:

• Ability to stand for extended periods while performing laboratory procedures.
• Ability to lift up to 25 lbs. (media, solvent containers, equipment parts).
• Work performed in controlled cleanroom and laboratory environments.
• Position may require occasional weekend, holiday, or off-shift work depending on production needs.

The application window for this position is anticipated to be open at least 25 days