Scientist II (Microbiology)

Fresenius Kabi • Wilson, NC

13d • Onsite

About The Position

A Scientist II in Quality Control Microbiology displays an advanced knowledge in microbiological test methods, instrumentation and guides others in routine test methods. A Scientist II participates in the mentoring and training of less experienced analysts in the group. The QC Microbiology department contains four main functional groups. The principal activities vary slightly between the groups.

Requirements

• Advanced knowledge in microbiological test methods, instrumentation
• Ability to guide others in routine test methods
• Ability to mentor and train less experienced analysts
• Knowledge of cGMPs and GLPs
• Knowledge of current compendial methods
• Ability to articulate work related issues clearly and effectively to management and peers
• Ability to investigate deviations from SOP requirements
• Ability to investigate nonconforming test results
• Ability to identify additional testing to be performed
• Ability to generate and update SOPs for microbiology test procedures
• Ability to train new department personnel in related SOPs
• Ability to adhere to safety related policies and make recommendations
• Responsible for maintenance of equipment and calibrations not performed by metrology or maintenance departments
• Organized to coordinate activities of multiple filling rooms and associated personnel
• Ability to assess environmental conditions using various methods
• Ability to recognize out of limit results and initiate OOL investigations
• Must successfully execute requirements to achieve ISO Class 5 gowning certification
• Advanced working knowledge of KabiTrack and recording OOL events
• Ability to investigate environmental OOL excursions
• Ability to coordinate responses and actions associated with environmental issues
• Ability to maintain good housekeeping of laboratory areas, environmental chambers and maintain inventory of test media, reagents
• Ability to complete activities required for microbial identification
• Ability to assist in training manufacturing personnel in required aseptic techniques, and gowning techniques
• Ability to coordinate the timely completion of routine and project testing
• Ability to process and complete data collection for all critical systems release
• Ability to process data and recognize issues and be instrumental in escalating associated results with unexpected results or trending
• Ability to schedule, initiate, coordinate, perform routine testing of in-process, finished product, raw material
• Responsible for coordination and collection of samples for annual testing requirements for component testing
• Ability to assure timely testing and result reporting for stability samples
• Ability to conduct environmental monitoring during bioburden testing and sterility testing (SKAN isolators)
• Ability to maintain testing equipment and coordinate requalification, preventative maintenance and calibration
• Ability to process paperwork, LIMS input and approvals for release by QA
• Ability to provide data for annual product reviews, investigational requests and validation studies
• Ability to develop and validate Microbiological test methods for all new products, including APIs, In-process and Finished Products.
• Ability to perform studies needed to support incoming new products into the company, justification methods for new stoppers and vials, PFBB validation, raw material bioburden/Bacterial Endotoxin method validations and finished products.
• Responsible for routine testing of in-process and finished product samples on exhibit/ Process validation batches.
• Ability to review and approve testing results of procedures performed in the department.
• Ability to develop study protocols to validate production and laboratory methods.
• Ability to provide support for plant and Lab equipment requalification studies.
• Ability to support Tech Transfer’s process validation protocols.
• Ability to perform microbiological testing for product process validation studies.
• Ability to author and execute BFR study protocols per established procedures to validate sterilizing grade filters used in manufacturing aseptic fill process of procures
• Responsible for performing routine testing of validation activities includes viability, spike-flush and filter compatibility studies.
• Ability to prepare microbial suspensions, media and reagents as needed.
• Ability to monitor environmental conditions in the laboratory.
• Ability to review and approve testing results of peer work.
• Ability to assist with laboratory qualification and requalification studies as needed.
• Ability to review standard operating procedures updates related to BFR.
• Ability to assist investigation of nonconforming test results for validation impact, root cause and strives to derive proper root causes and applicable CAPA’s.
• Ability to maintain laboratory equipment and coordinate preventive maintenance, calibration and requalification

Responsibilities

• Understands department priorities and importance of planning ahead.
• Performs peer review of data for accuracy, completeness and conformance to specifications.
• Keeps supervisory personnel informed of all relevant events impacting the operations and performance of the department including discrepancies and out of limit conditions.
• Be able to articulate work related issues clearly and effectively to management and peers.
• Maintains knowledge of cGMPs and GLPs. Maintains knowledge of current compendial methods.
• Teach or coordinate teaching of training modules and laboratory techniques to new analysts
• Assists in authoring basic investigative studies (OOS, OOT, OOL) and other necessary documents for the Quality Control Microbiology department.
• Supports senior personnel in various projects including investigations, special testing and project work. Investigates deviations from SOP requirements as directed by supervision for potential impact to product and materials and derives root cause of the incident.
• Investigates nonconforming test results including environmental monitoring for product impact, root cause, and evaluates results to provide conclusions and appropriate corrective action.
• Identifies additional testing to be performed to resolve these issues in a timely manner.
• Generates and updates SOPs for microbiology test procedures. Updates and keeps others current.
• Trains new department personnel in related SOPs.
• Ensures safety related polices are adhered and makes recommendations to enhance or improve safety policies.
• Responsible for all aspects of maintenance of equipment and calibrations not performed by metrology or maintenance departments.
• Performs other duties as assigned.
• Schedules, initiates, coordinates, performs routine and non-routine environmental monitoring according to established procedures. Must be organized to coordinate activities of multiple filling rooms and associated personnel.
• Assess environmental conditions using various methods to sample environment, water systems, compressed gas, and personnel in production areas and microbiology laboratory. Recognize out of limit results and initiate OOL investigations.
• Must successfully execute requirements to achieve ISO Class 5 gowning certification.
• Processes paperwork, LIMS input and approvals for release by QA Critical Systems.
• Advanced working knowledge of KabiTrack and recording OOL events. Investigate environmental OOL excursions.
• Coordinate responses and actions associated with environmental issues
• Maintain good housekeeping of laboratory areas, environmental chambers and maintain inventory of test media, reagents as assigned.
• Completes activities required for microbial identification including sub-culture, Gram staining, proper culture maintenance and processing for outside laboratory identification.
• Assists in training manufacturing personnel in required aseptic techniques, and gowning techniques as assigned by supervisor.
• Responsible for coordinating the timely completion of routine and project testing.
• Processes and completes data collection for all critical systems release.
• Process data and recognize issues and be instrumental in escalating associated results with unexpected results or trending.
• Schedules, initiates, coordinates, performs routine testing of in-process, finished product, raw material.
• Responsible for coordination and collection of samples for annual testing requirements for component testing.
• Assures timely testing and result reporting for stability samples.
• Conduct environmental monitoring during bioburden testing and sterility testing (SKAN isolators)
• Maintains testing equipment and coordinates requalification, preventative maintenance and calibration as needed
• Processes paperwork, LIMS input and approvals for release by QA.
• Provides data for annual product reviews, investigational requests and validation studies
• Develops and Validates Microbiological test methods for all new products, including APIs, In-process and Finished Products.
• Performs studies needed to support incoming new products into the company, justification methods for new stoppers and vials, PFBB validation, raw material bioburden/Bacterial Endotoxin method validations and finished products.
• Responsible for routine testing of in-process and finished product samples on exhibit/ Process validation batches.
• Reviews and approves testing results of procedures performed in the department. Writes and revises standard operating procedures (SOP).
• Develops study protocols to validate production and laboratory methods.
• Provides support for plant and Lab equipment requalification studies.
• Supports Tech Transfer’s process validation protocols.
• Performs microbiological testing for product process validation studies.
• Authors and executes BFR study protocols per established procedures to validate sterilizing grade filters used in manufacturing aseptic fill process of procures
• Responsible for performing routine testing of validation activities includes viability, spike-flush and filter compatibility studies.
• Prepares microbial suspensions, media and reagents as needed.
• Monitors environmental conditions in the laboratory.
• Reviews and approves testing results of peer work.
• Assists with laboratory qualification and requalification studies as needed.
• Reviews standard operating procedures updates related to BFR.
• Assists investigation of nonconforming test results for validation impact, root cause and strives to derive proper root causes and applicable CAPA’s.
• Maintains laboratory equipment and coordinates preventive maintenance, calibration and requalification

Benefits

• 401(k) plan with company contributions
• Paid vacation
• Holiday and personal days
• Employee assistance program
• Health benefits to include medical, prescription drug, dental and vision coverage
• Life insurance
• Disability
• Wellness program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed