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Fresenius Kabi USA · 17 hours ago

Scientist II

Wilson, NC

Full-time

Onsite

Mid Level

$29.31/hr - $41.20/hr

Fresenius Kabi USA is a leader in the healthcare industry, focusing on essential medications and technologies. The Scientist II in Quality Control Microbiology is responsible for advanced microbiological testing, mentoring less experienced analysts, and ensuring compliance with regulatory standards.

Health Care

H1B Sponsor Likely

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)

Completes activities required for microbial identification including sub-culture, Gram staining, proper culture maintenance and processing for outside laboratory identification

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

Qualification

Microbiological test methodsEnvironmental monitoringSOP developmentMicrobial identificationLIMS proficiencyCGMP knowledgeGLP knowledgeTrainingData analysisMentoringTeam collaboration

Required

Advanced knowledge in microbiological test methods and instrumentation

Ability to mentor and train less experienced analysts

Understanding of department priorities and importance of planning ahead

Ability to perform peer review of data for accuracy, completeness and conformance to specifications

Ability to keep supervisory personnel informed of relevant events impacting operations and performance

Ability to articulate work related issues clearly and effectively to management and peers

Knowledge of cGMPs and GLPs

Knowledge of current compendial methods

Ability to teach or coordinate teaching of training modules and laboratory techniques

Ability to assist in authoring basic investigative studies (OOS, OOT, OOL) and other necessary documents

Ability to support senior personnel in various projects including investigations and special testing

Ability to investigate deviations from SOP requirements and derive root cause

Ability to investigate nonconforming test results and evaluate results to provide conclusions and corrective action

Ability to identify additional testing to resolve issues in a timely manner

Ability to generate and update SOPs for microbiology test procedures

Ability to train new department personnel in related SOPs

Ability to ensure safety related policies are adhered to and make recommendations for improvement

Responsibility for maintenance of equipment and calibrations

Ability to schedule, initiate, coordinate, and perform routine and non-routine environmental monitoring

Ability to assess environmental conditions using various methods

Ability to execute requirements to achieve ISO Class 5 gowning certification

Ability to process paperwork, LIMS input and approvals for release by QA Critical Systems

Advanced working knowledge of KabiTrack and recording OOL events

Ability to coordinate responses and actions associated with environmental issues

Ability to maintain good housekeeping of laboratory areas and inventory of test media and reagents

Ability to complete activities required for microbial identification

Ability to assist in training manufacturing personnel in required aseptic techniques

Responsibility for coordinating 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

Ability to schedule, initiate, coordinate, and perform routine testing of in-process, finished product, raw material

Responsibility for coordination and collection of samples for annual testing requirements

Ability to assure timely testing and result reporting for stability samples

Ability to conduct environmental monitoring during bioburden testing and sterility testing

Ability to maintain testing equipment and coordinate requalification, preventative maintenance and calibration

Ability to provide data for annual product reviews, investigational requests and validation studies

Ability to develop and validate microbiological test methods for new products

Ability to perform studies needed to support incoming new products

Responsibility for routine testing of in-process and finished product samples

Ability to review and approve testing results and write/revise standard operating procedures

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

Responsibility for performing routine testing of validation activities

Ability to prepare microbial suspensions, media and reagents

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

Ability to review standard operating procedures updates related to BFR

Ability to assist investigation of nonconforming test results for validation impact

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

Company

Fresenius Kabi USA

Fresenius Kabi is health care company specializing in medical and medical technologies.

Founded in 1996

Lake Zurich, Illinois, USA

1001-5000 employees

http://www.fresenius-kabi.us

H1B Sponsorship

Fresenius Kabi USA has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (13)

2024 (17)

2023 (17)

2022 (15)

2021 (14)

2020 (22)