Scientist II

Fresenius Kabi•Wilson, NC

12h•$29 - $41

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. Hourly Range: $29.31 - $41.20 Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

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
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