Scientist I

Fresenius Kabi USA • Wilson, NC

2d • $29 - $41

About The Position

A Scientist I in Quality Control Microbiology is responsible for an intermediate level of expertise of microbiological test methods, and instrumentation. A Scientist I participate 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

• Intermediate level of expertise of microbiological test methods, and instrumentation.
• Participate in the mentoring and training of less experienced analysts in the group.
• Maintains knowledge of cGMPs and GLPs.
• Maintains knowledge of current compendial methods.
• Solid working knowledge of KabiTrack and recording OOL events and change controls.
• Scientist I may know most but not all procedures used.

Nice To Haves

• Assists in authoring basic investigative studies (OOS, OOT, OOL, invalid tests) 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.
• Assists in training manufacturing personnel in required aseptic techniques, and gowning techniques as assigned by supervisor.
• Assists with investigation of environmental OOL excursions.
• Assists with laboratory qualification and requalification studies as needed.
• Assists investigation of nonconforming test results for validation impact, root cause and strives to derive proper root causes and applicable CAPA’s.

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, invalid tests) 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.
• Updates SOPs or Methods of Analysis for microbiology test procedures to remain current.
• 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 and do independently.
• 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.
• Solid working knowledge of KabiTrack and recording OOL events and change controls. Assists with investigation of 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 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. Scientist I may know most but not all procedures used.
• Conduct environmental monitoring during bioburden testing and sterility testing (SKAN isolators)
• Maintains testing equipment and coordinates requalification, preventative maintenance and calibration as needed
• Provides data for annual product reviews, investigational requests and validation studies.
• Validates Microbiological test methods for all new products, including APIs, In-process and Finished Products.
• Performs studies as assigned 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. Revises standard operating procedures (SOP).
• Executes 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 and can update standard operating procedures related to BFR using Documentum.
• 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: Entry Level
• Education Level: No Education Listed