QC Microbiologist II

4 days left

Employer
Kedrion Biopharma, Inc.
Location
Melville, New York, US
Salary
Competitive
Posted
Jun 04, 2021
Closes
Jun 16, 2021
Ref
2181912167
Discipline
Other
Employment Type
Full time
Salary Type
Salary
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.
Main Responsibilities:
- Perform Environmental Monitoring associated with manufacturing area. Monitoring includes total particulate monitoring, viable air sampling, surface plating of the classified areas, and personnel monitoring.
- Collect WFI, Pure Steam and Purified Water samples associated with the manufacturing areas and subsequently test the samples for presence of bioburden and endotoxin.
- Perform growth promotion testing on culture media used in the manufacturing process; includes in-process and environmental monitoring media
- Perform release testing on raw materials required for use in the manufacturing process.
- Perform routine laboratory duties to support the overall function of the microbiology laboratory such as preparation of autoclave loads, biosafety cabinet and laminar flow hood cleaning and maintenance.
- Perform routine biological laboratory assays such as pH and buffer preparation as specified in appropriate SOPs.
- Review current SOPs for accuracy and have the ability to make modifications when appropriate
Knowledge, Skills & Technical Expertise:
- Should understand cGMP, FDA and other regulatory requirements
- Demonstrated capability with Microbiological instruments such as Microscopes, Lasairs, RCS/SAS
- Must be able to work in a controlled environment requiring specified gowning
- Must be able to work overtime as needed
- Must be able to work weekends as needed
Measurement of Performance:
- Maintain a Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
- Demonstrate consistent Timeliness and accuracy in completion of projects and paperwork (quantity of work)
- Demonstrated contribution to projects beyond general responsibilities (quality of work), as assigned.
- Ability to identify problem areas affecting operations (knowledge/problem solving) and communicate to proper resource for resolution
- Contributes to improvement of assigned activities, offers suggestions for correcting problems and for improving operations
- Exercises good judgment in dealing with operational problems, resolving where appropriate, escalating where necessary
- Demonstration of improved Understanding of theory, rationale behind tasks performed
- Demonstrated understanding and adherence to Kedrion policies, safety procedures and the cGMPs
- Ability to contribute in a team-oriented environment under very dynamic conditions
Supervision
- Work under general supervision to meet company goals
Qualifications:
- Bachelor's Degree in Microbiology or Biological Sciences and 2 to 5 years of related laboratory experience in the pharmaceutical industry; or an equivalent combination of training and experience.
- Experience with creating spreadsheets in Excel and technical documents in Microsoft Word
- Must have cleanroom/Aseptic Area experience specifically Grade A/B/C/D area.
- Must have exceptional aseptic technique
- Demonstrated contribution to projects beyond general responsibilities (quality of work), as assigned.
- Ability to identify problem areas affecting operations (knowledge/problem solving) and communicate to proper resource for resolution
- Must have the ability to coordinate multiple tasks concurrently and complete tasks in a timely manner
- Must be detail oriented, conscientious and have a high reading comprehension skill
- Must have scientific writing skills and can prepare technical studies and SOPs
Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee will be trained under OSHA's HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.
In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.
All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and/or the requirements of RCRA.

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