Analyst II, QC Microbiology-2nd Shift
Bora Pharmaceuticals
Baltimore, MD
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JOB DETAILS
LOCATION
Baltimore, MD
POSTED
30+ days ago
JOB SUMMARY
The Analyst II, QC Microbiology position supports the Quality Control group at Bora Pharmaceuticals Camden Campus to maintain process optimization and manufacturing activities. The Microbiologist is responsible for performing activities in support of the Microbiology, Environmental Monitoring, and Utility testing programs, which includes microbiological product testing, monitoring of the manufacturing production space, and supporting quality initiatives.
The individual routinely conducts monitoring, testing, and SOP generation and revision.
This position will support the 2nd shift, working 2pm-10:30pm, Monday-Friday.
ESSENTIAL FUNCTIONS
*Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.*
- Achieve gowning and aseptic qualification within 4 months.
- Maintains aseptic qualification and ability to support aseptic filling operations, up to 50% of time directly supports aseptic operations.
- Maintains gowning qualification.
- Perform various microbiological testing procedures as per
Manufacturing/Quality Control batch records, stability protocols, raw material requests for testing, etc.
- Perform environmental monitoring and utility testing of the facility proficiently.
- Performs environmental monitoring during fill operations proficiently.
- Work with Project Managers and QA to ensure timely testing and release of samples.
- Inform supervisor/manager upon observing OOS, OOL, or generation of deviations
- Participate in investigations of OOS results and other related studies.
- Participate in validation, troubleshooting various types of equipment including proactive resolution of instrument issues.
- Investigate and suggest new laboratory
procedures/techniques.
- Validate and implement new laboratory
procedures/techniques.
- Update existing or write new testing standards and standard operating procedures.
- Train Microbiologist I and II in methods and techniques
- Review, analyze, interpret and report data.
- Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
- Support department compliance and productivity goals.
- Write and review monthly reports as necessary.
- Track time worked per project.
- Owns Change Controls and change actions.
- Authors deviation investigations.
- Proficient with document management system and owns updates to procedures.
- Perform Aseptic
Technique/Contamination Control Training.
- Observe and report issues during filling operations.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
*Education: BS in Microbiology/Biology or related field*
*Experience:* *Minimum 2-4 years (MS with 0-2 years) in the Pharmaceutical or Biotechnology with emphasis in one of the following areas: aseptic processing, QC microbiology, environmental monitoring, water system, quality control, validation and manufacturing processes.*
Technical/Professional Knowledge *having achieved a satisfactory level of technical and professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise.*
Problem Solving *the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully.*
Safety and Security*the individual observes safety and security procedures and uses equipment and materials properly. May be required to lift items that are approximately 25lbs.*
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About the Company
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