Analyst II, QC Microbiology-1st Shift

Bora Pharmaceuticals•Baltimore, MD

1d•Onsite

About The Position

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.

Requirements

BS in Microbiology/Biology or related field
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 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.
Communication— Effective verbal and written communication, the ability to complete daily tasks as assigned, the ability to work independently and in a group, and the ability to multi-task.
Speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts productive meetings.
Quality Management— Looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.
Planning/Organizing— Prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
Adaptability – Maintains effectiveness when experiencing major changes in work tasks or the work environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
Stress Tolerance— Maintains stable performance under pressure or opposition (such as time pressure or job ambiguity); handling stress in a manner that is acceptable to others and to the organization.
Maintain attention to detail; have strong verbal communication skills with internal teams.
Ability to succeed in a team-oriented environment under very dynamic conditions.
Must be able to write legibly and accurately and contemporaneously record work in written and electronic form.

Nice To Haves

Proven demonstration of qualifications related to Excel, Word, LIMS, or SAP systems is preferred, including course work.

Responsibilities

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 & 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.