Scientist I

301044 Fresenius Kabi USA, LLC; Kansas; On-site; USD 40,000 - 56,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation, holidays and personal

Health benefits: medical, prescription

Dental and vision coverage

Life insurance

Disability

Wellness program

Job summary

FreseniusKabi USA, LLC, headquartered in the United States, seeks a Scientist I in Quality Control Microbiology. The role involves microbiological test methods, mentoring analysts, and ensuring compliance with cGMPs and GLPs across multiple QC groups.

The position offers an hourly range with pay determined by experience and education, along with a comprehensive benefits package including health, dental, vision, and 401(k) with company contributions. This is an on-site role in the U.S.

Qualifications

• Experience in QC Microbiology and environmental monitoring.
• Ability to review data for accuracy and conformance to specs.
• Mentor and train junior analysts in laboratory techniques.

Responsibilities

• Coordinate environmental monitoring and sample handling across rooms.
• Perform and document routine microbial testing of in-process and finished products.
• Validate methods; adjust SOPs; ensure compliance with cGMPs/GLPs.

Skills

Microbiology

Data review

Mentoring

Communication

cGMPs/GLPs

Tools

KabiTrack

LIMS

Documentum

Job description

Job Summary 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.

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.
• We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Principal activities performed by the incumbent

• 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.

Environmental Monitoring

• 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.

Finished Products Testing

• 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).
• 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.

Validations

• 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.

Bacterial Filter Retention (BFR) Laboratory

• 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.

Additional Information

Please note that joining our team does not create a guaranteed or permanent employment arrangement.

All employment is at‑will, meaning both the employee and FreseniusKabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

FreseniusKabi is an Equal Opportunity/Affirmative Action employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

FreseniusKabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life.

Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.

Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr

We look forward to talking to you about joining our team.