Job Description

RESPONSIBILITIES

1. Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.

2. Execute microbiological and/or analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers.

3. Perform environmental monitoring sampling and testing of facilities, equipment, and utilities.

4. Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports.

5. Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments, and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness.

6. Assist with monitoring and the control of laboratory supply and critical reagent

inventories.

7. Perform growth promotion of media and microbial identification testing.

8. Qualify as trainer for specified methods, provide training to less experienced staff.

9. Provide on call coverage to support oversight of QC laboratory equipment functionality.

10. Exhibit proactive communication upon occurrence of compliance risks and deviations

from laboratory procedures, perform initiation of investigation records within required timeframes.

11. Provide input or assay support to the progression of test method validation,

investigations, technical studies, and method transfer protocols.

12. Attend team huddles and department meetings, generate ideas for laboratory

infrastructure improvements and method optimization.

13. Perform other responsibilities as deemed necessary.

EDUCATION

1. Bachelor of Science degree.

2. 0-3 years of relevant laboratory experience; QC specific experience is preferred.

QUALIFICATIONS

1. Experience with quality management systems, current Good Manufacturing Practices, and QC principles.

2. Demonstrated working knowledge with respect to certified functional activities.

3. Good documentation, written and verbal communication skills are essential.

4. Must possess the ability to perform most tasks with minimal supervision.

5. Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, or Visio is desired.

6. Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.

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