Scientist II; Microbiology

Job Summary

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.

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.

• 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 Kabi Track 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…