Category: Scientific & Clinical
Title: QC Analyst II/III - Data Review
Location: Baltimore, MD
- Assists with documentation and review of microbial testing (includes bioburden and endotoxin) as required to support product release, water testing, and environmental monitoring results.
- Ensures the reliability and accuracy of the computer databases, and paper files.
- Verify calculations and documented information (reagent expiry, reagent preparation, instrument calibration, logbook entries, control charts, etc.) are present, complete, and accurate
- Provides technical and scientific assistance/expertise as required to clarify and troubleshoot scientific challenges internally or in collaboration with other departments as a member of a cross-functional team.
- Audit raw data generated during microbial testing of raw materials, in-process materials and finished products, environmental monitoring (includes non-viable and viable samples), and water sample testing (includes TOC, Conductivity, bioburden testing, and endotoxin) for accuracy, completeness, and compliance with test method, procedures, specifications, cGMPS, and internal SOP requirements.
- Review LIMS reports of the results for accuracy
- Review raw data generated during method validation/verification for accuracy and compliance with test method procedures, validation protocols, cGMPS, and internal SOP
- Train new reviewers
- Bachelor’s degree in microbiology, biology, or related field of study.
- Minimum of 2-5 years directly related experience in the pharmaceutical/biopharmaceutical micro laboratory.
- Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
- Proficient and professional communicator, verbally and in writing.
- Demonstrated technical competence; can analyze data and interpret results to make scientifically valid conclusions.
- Strong organizational and interpersonal skills and the ability to work collaboratively with others.
- Proficient in complex procedures and problem solving.
- Strong commitment to teamwork, proven leadership skills, independence and initiative.
- Ability to work effectively under pressure to meet deadlines
- Familiarity with compendial testing
- Extensive knowledge of bioburden testing, endotoxin methods, WFI and Pure steam analyses
- Proficient in Microsoft Office - Word, Excel, PowerPoint.
- Comprehensive knowledge of pharmaceutical GLPs and GMPs.
- Comprehensive knowledge of laboratory techniques and safety precautions.
- Comprehensive knowledge of regulatory/industry guidance.
- Knowledge of LIMS preferred.
- Ability to work flexible hours when needed
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.