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North Carolina, United States
Onsite
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
All Scientist II groups are responsible for the following
1. Understands department priorities and importance of planning ahead.
2. Performs peer review of data for accuracy, completeness and conformance to specifications.
3. Keeps supervisory personnel informed of all relevant events impacting the operations and performance of the department including discrepancies and out of limit conditions.
4. Be able to articulate work related issues clearly and effectively to management and peers.
5. Maintains knowledge of cGMPs and GLPs. Maintains knowledge of current compendial methods.
6. Teach or coordinate teaching of training modules and laboratory techniques to new analysts
7. Assists in authoring basic investigative studies (OOS, OOT, OOL) and other necessary documents for the Quality Control Microbiology department.
8. 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.
9. Investigates nonconforming test results including environmental monitoring for product impact, root cause, and evaluates results to provide conclusions and appropriate corrective action.
10. Identifies additional testing to be performed to resolve these issues in a timely manner.
11. Generates and updates SOPs for microbiology test procedures. Updates and keeps others current.
12. Trains new department personnel in related SOPs.
13. Ensures safety related polices are adhered and makes recommendations to enhance or improve safety policies.
14. Responsible for all aspects of maintenance of equipment and calibrations not performed by metrology or maintenance departments.
15. Performs other duties as assigned.
Environmental Monitoring
1. 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.
2. 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.
3. Must successfully execute requirements to achieve ISO Class 5 gowning certification.
4. Processes paperwork, LIMS input and approvals for release by QA Critical Systems.
5. Advanced working knowledge of KabiTrack and recording OOL events. Investigate environmental OOL excursions.
6. Coordinate responses and actions associated with environmental issues
7. Maintain good housekeeping of laboratory areas, environmental chambers and maintain inventory of test media, reagents as assigned.
8. Completes activities required for microbial identification including sub-culture, Gram staining, proper culture maintenance and processing for outside laboratory identification.
9. Assists in training manufacturing personnel in required aseptic techniques, and gowning techniques as assigned by supervisor.
10. Responsible for coordinating the timely completion of routine and project testing.
11. Processes and completes data collection for all critical systems release.
12. Process data and recognize issues and be instrumental in escalating associated results with unexpected results or trending.
Finished Products Testing
1. Schedules, initiates, coordinates, performs routine testing of in-process, finished product, raw material.
2. Responsible for coordination and collection of samples for annual testing requirements for component testing.
3. Assures timely testing and result reporting for stability samples.
4. Conduct environmental monitoring during bioburden testing and sterility testing (SKAN isolators)
5. Completes activities required for microbial identification including sub-culture, Gram staining, proper culture maintenance and processing for outside laboratory identification.
6. Maintains testing equipment and coordinates requalification, preventative maintenance and calibration as needed
7. Processes paperwork, LIMS input and approvals for release by QA.
8. Provides data for annual product reviews, investigational requests and validation studies
Validations
1. Develops and Validates Microbiological test methods for all new products, including APIs, In-process and Finished Products.
2. 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.
3. Responsible for routine testing of in-process and finished product samples on exhibit/ Process validation batches.
4. Reviews and approves testing results of procedures performed in the department. Writes and revises standard operating procedures (SOP).
5. Develops study protocols to validate production and laboratory methods.
6. Provides support for plant and Lab equipment requalification studies.
7. Supports Tech Transfer’s process validation protocols.
8. Performs microbiological testing for product process validation studies.
Bacterial Filter Retention (BFR) Laboratory
1. Authors and executes BFR study protocols per established procedures to validate sterilizing grade filters used in manufacturing aseptic fill process of procures
2. Responsible for performing routine testing of validation activities includes viability, spike-flush and filter compatibility studies.
3. Prepares microbial suspensions, media and reagents as needed.
4. Monitors environmental conditions in the laboratory.
5. Reviews and approves testing results of peer work.
6. Assists with laboratory qualification and requalification studies as needed.
7. Reviews standard operating procedures updates related to BFR.
8. Assists investigation of nonconforming test results for validation impact, root cause and strives to derive proper root causes and applicable CAPA’s.
9. Maintains laboratory equipment and coordinates preventive maintenance, calibration and requalification
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.
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 Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.
Fresenius Kabi 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.