QC Microbiologist III

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
• Support Environmental Monitoring associated with manufacturing area.
• Support 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/release testing and environmental monitoring media
• Support release testing on raw materials required for use in the manufacturing process.
• 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
• Execute validation protocols associated with cleaning validations and HVAC validations.
• May be required to prepare technical report studies, route for appropriate review and subsequently execute.
• Perform data collection, trending and analysis using Excel based programs.
• Support CAPA and Change Controls
• Provide SME support for deviations
Supervision
• Work independently under general supervision to meet company goals
• May work in teams or assigned project groups in multi-functional or cross functional project team
Measurement of Performance
• Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
• Timeliness and accuracy in completion of projects and paperwork (quantity of work)
• Contributions to projects beyond general responsibilities (quality of work)
• Identification of problem areas affecting operations (knowledge/problem solving)
• Offers suggestions for correcting problems and for improving operations, can demonstrate independence and exercises good judgment in dealing with operational problems
• Demonstrated expertise regarding theory and rationale behind tasks performed
• Demonstrated understanding and adherence to Kedrion policies, safety procedures and the cGMPs, ability to independently identify and correct conditions as they occur
• Ability to contribute successfully in a team-oriented environment under very dynamic conditions
• Ability to manage time and multiple project or task assignment in a manner that contributes to and meets expectations for right first time and on-time delivery
• Demonstrated flexibility to change priorities and deliverables in a dynamic and fast paced environment
Qualifications
• Bachelor's Degree in Microbiology or Biological Sciences with 5 to 10 years of related laboratory experience in the pharmaceutical industry; or two (2) or more years of experience as a Microbiologist II; or an equivalent combination of training and experience.
• Experience with creating spreadsheets in Excel and technical documents in Microsoft Word
• Knowledge of Trackwise preferred
• Skilled use of Microsoft Office Suite
• Must have cleanroom/Aseptic Area experience specifically Grade A/B/C/D area.
• Must have exceptional aseptic technique
• 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 have the ability to prepare technical studies and SOPs.
• 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
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.