Analyst I, QC Microbiology (3rd shift)

Bora Pharmaceuticals•Baltimore, MD

1d•$60,000 - $75,000•Onsite

About The Position

Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. The Analyst I, QC Microbiology is responsible for conducting qualitative and quantitative microbial analyses in support of environmental monitoring, cGMP manufacturing and stability of drug products and incoming raw materials. The Microbiologist is responsible for performing activities in support of the Microbiology, Environmental Monitoring, and Utility testing programs. This position will support our 3rd shift Operations, working 10pm-6:30am Monday-Friday. Shift differential.

Requirements

BS in Microbiology/Biology or related field
Minimum of 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.
College and industry-level knowledge of general microbiology principles.
Demonstrate the ability to investigate and identify causes of suspect laboratory results.
Must be comfortable working in cleanrooms and BSC environments in aseptic gowning for extended periods of time.
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.
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.
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.
Performs environmental monitoring during fill operations.
Operation of a biohazard trash autoclave.
Perform daily checks on equipment.
Stock the lab on a daily basis.
Cleaning the lab and equipment.
Prepping of materials requiring sterilization.
Inform supervisor/manager upon observing OOS, OOL, or generation of deviations.
Participate in validation, troubleshooting various types of equipment including proactive resolution of instrument issues.
Write and review SOP’s and Testing Standards as necessary.
Review, analyze, interpret and report data.
Verifies and enters approved results in laboratory information management systems (LIMS).
Prepare disinfectant solutions, reagents, samples for analyses.
Participate in investigations and other related studies.
Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures.
Track time worked per project.
Observe and report issues during filling operations.