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Fresenius Kabi · 18 hours ago

Scientist II

Wilson, NC

Full-time

Onsite

Mid Level

$29.31/hr - $41.20/hr

Fresenius Kabi is a healthcare company that specializes in products and services for the acute and chronic care of patients. The Scientist II in Quality Control Microbiology will utilize advanced microbiological knowledge to mentor less experienced analysts and ensure compliance with testing methods and quality standards. This role involves various responsibilities including environmental monitoring, finished product testing, and validation of microbiological test methods.

BiotechnologyHealth CarePharmaceutical

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 monitoringMicrobial identificationSOP developmentLIMS proficiencyCGMP knowledgeTraining skillsTeam collaborationProblem-solving

Required

Advanced knowledge in microbiological test methods and instrumentation

Ability to mentor and train less experienced analysts

Knowledge of cGMPs and GLPs

Ability to articulate work-related issues clearly and effectively

Experience in authoring basic investigative studies (OOS, OOT, OOL)

Experience in investigating deviations from SOP requirements

Ability to generate and update SOPs for microbiology test procedures

Experience in training new department personnel in related SOPs

Ability to maintain equipment and calibrations

Experience in scheduling and performing environmental monitoring

Ability to assess environmental conditions and recognize out of limit results

Experience in microbial identification including sub-culture and Gram staining

Experience in coordinating routine testing of in-process, finished product, and raw material

Ability to develop and validate microbiological test methods

Experience in reviewing and approving testing results

Ability to author and execute study protocols for validation

Experience in performing routine testing of validation activities

Ability to monitor environmental conditions in the laboratory

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

Glassdoor3.9

Fresenius Kabi is a health care company, that offers therapy and care of chronically seriously ill people - in and out of hospitals.

Founded in 1999

Bad Homburg, Hessen, DEU

10001+ employees

https://www.fresenius-kabi.se

H1B Sponsorship

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