Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
Schedule:
Currently 4-10 work hours, with 4 shifts: Sundays- Wed- Days/ Swings (7-6/1-11) and Wed-Sat - Days/ Swings with an overlap on Wednesdays. Seeking candidates who can be OPEN to being flexible in switching their shifts if necessary. Early notice would be provided in the event a switch becomes needed
Responsibilities:
- Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices.
- 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.
- Perform environmental monitoring sampling and testing of facilities, equipment, and utilities.
- 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.
- 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.
- Assist with monitoring and the control of laboratory supply and critical reagent inventories.
- Perform growth promotion of media and microbial identification testing.
- Qualify as trainer for specified methods, provide training to less experienced staff.
- Provide on call coverage to support oversight of QC laboratory equipment functionality.
- Exhibit proactive communication upon occurrence of compliance risks and deviations
- from laboratory procedures, perform initiation of investigation records within required timeframes.
- Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols.
- Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization.
- Perform other responsibilities as deemed necessary.
Qualifications:
- Experience with quality management systems, current Good Manufacturing Practices, and QC principles.
- Demonstrated working knowledge with respect to certified functional activities.
- Good documentation, written and verbal communication skills are essential.
- Must possess the ability to perform most tasks with minimal supervision.
- Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, or Visio is desired.
- Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.
Education:
- Bachelor of Science degree.
- 0-3 years of relevant laboratory experience; QC specific experience is preferred.
