Microbiology Analyst

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• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status. Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine. Performs general to moderately technical microbiological duties in testing of in process samples, raw materials, finished products, stability, and process validation samples; perform environmental monitoring (EM); completes pertinent documentation associated with activities; and performs related duties as assigned.

Main Responsibilities:

This list is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may be assigned certain tasks as the primary responsibility but will also be expected to support other described functions as necessary.

• Support laboratory management by contributing with:
• Conduct housekeeping (e.g., Autoclave loads, Depyrogenation ovens, Daily stocking, Dishwashing, Weekly expiration check).
• Perform weekly reagents check and reagent inventory for reorder.
• Equipment calibration/PM (balance, pipettes).
• Conduct monthly safety walk thru inspection and Eyewash station check.
• Ship samples to external vendors, Testing laboratories.
• EM Cleaning of Booth/Bioburden Suite, and Flow Hoods.
• EM of laboratories LFH/BSC.
• General Support for reagent preparation, purchase order, sample, and reagents receipt.
• Execute microbiological techniques applied to in process samples, characterization samples, raw materials etc.:
• Microbial Support Testing (NAT, Growth Promotion).
• EM Water Testing (Collection, data entry, bioburden, LAL).
• EM (Facility support for gowning and filling).
• EM Utilities (Pharm Air, Nitrogen Testing).
• EM Facility Support (viable air, contact plates, passive air, total particulate count).
• Microbial Testing Bioburden and LAL (Raw Materials, Validation, In-Process Samples).
• Documentation tasks:
• Logbook Review (Balance, Bioburden, Autoclave, etc.).
• Initiate Lab Investigations & Lab Events.
• Initiate Deviations.
• Enter data for Trending (control, release data, Lab events).
• Perform SOP review as needed.
• Ensure compliance with training protocol and keep training binder updated.
• Complies with safety practices; ensures the collection and proper disposal of hazardous waste from laboratory instruments.
• Measurement of Performance
• Generates and maintains a positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors.
• Demonstrates timeliness and accuracy in completion of assigned tasks.
• Demonstrates understanding and adherence to Kedrion policies, safety procedures and the cGMPs.
• Demonstrate flexibility and adaptability that enhances a successful team-oriented environment under very dynamic conditions.
• Qualifications
• Scientific degree. Microbiology or Biological Sciences preferred.
• Previous experience in microbiological and environmental monitoring techniques is preferred.
• Previous experience with aseptic technique is preferred.
• Previous experience in Quality control or in GMP environment is preferred.
• Good written and verbal communication skills.
• Good organizational skills.
• Skilled use of Microsoft Office Suite.

Note: This position may require the labeling, packaging, or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained. In lieu of HAZWOPER training, the employee will receive training on the requirements of the New York State hazardous waste management regulations pursuant to 6 NYCRR §373-3.2. All employees that have received the above-mentioned training within the first six months of hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the personnel training requirements of the NYSDEC.