Microbiologist II - CAPS {Mid shift: Monday - Friday (11:00am-8:00pm)}
B. Braun
- Allentown, PA
- $65,302-81,628 per year
- Permanent
- Full-time
CAPS is part of the B. Braun Group of Companies in the U.S.ResponsibilitiesPosition Summary:Responsibilities: Essential Duties.
- Plans, coordinates and organizes the overall activities of the Microbiological Laboratory according to internal and external standards in a most cost effective way.
- Direct responsible for the supervision test operation at all time for Sterility Testing, Bacterial Endotoxin Test, Microbiological Identification Sections and handling of laboratory 00S result.
- Ensures that the necessary microbiological tests are done according to the test specification, test method and working instruction and to ensure release on time for pharmaceutical products and medical devices.
- Responsible for the preparation and updating of the GMP/ISO procedures in the area of responsibility.
- Participates in projects, task force jointly with production personnel in case the needs arise.
- Prepares trend analysis and data compilation on deviation in the production process when required.
- Participates in internal and external audit.
- Participates in the Global Microbiology Task Team, whenever required.
- Responsible in microbiological release of medical devices or Pharma products and Pharma incoming materials.
- Supports microbiological tasks for process validation.
- Trains and proactively develops the education standard of the responsible persons.
- Quality, technical data review and investigation oversight.
- Collaborate with all departments and reports metrics to site management to continuously drive quality improvements.
- Familiar with Data Integrity and GDP in a cGMP Laboratory environment.
- Theoretical knowledge of subject matter, cGMP, FDA guidelines, GLP and USP’s. Complete knowledge of good analytical and laboratory techniques, basic knowledge of cGMP’s, GLP’s, SOP’s, USP and FDA requirements.
- Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course-of action.
- Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of other peers.
- Judgement is required in resolving complex problems based on experience.
- Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.
- cGMP experience/training required, Aseptic processing training/experience required
- Bachelors degree required, Master's degree preferred.
- Proven and/or demonstrated skills/abilities in leadership, educational training and/or experience will be taken into consideration.
- Previous supervisory experience.
- cGMP experience/training required, Aseptic processing training/experience required
- Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
- Occasionally: Reaching upward and downward, Push/pull
- Frequently: Stand, Sit, Visual Acuity with or without corrective lenses
- Constantly: N/A
- Occasionally: Finger feeling, Reaching upward and downward, Talking - ordinary, loud/quick
- Frequently: Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Standing, Walking
- Constantly: N/A
- Occasionally: Gases
- Frequently: Exposure to toxic or caustic chemicals (in most areas) , Fumes
- Constantly:N/A
- Noise Intensity:Moderate
- Occasionally: Other
- Frequently: Lab environment
- Constantly: N/A