Sr Quality Control Specialist

Description

Primary Duties:

1. Perform all work in compliance with company quality procedures and standards.
2. Oversee NCR investigations including following up on investigations, training supervisors and staff on how to complete NCRs, completing investigations that cross shifts as needed, and forwarding completed NCRs to managers for final approval.
3. Ensure the timeliness of NCR investigations and track/ monitor the turn-around time of QC NCRs.
4. Maintain dataset(s) to monitor and evaluate QC performance including Event NCRs, DHR corrections, not Right First Time, etc., and disseminate the results of these evaluations to shifts as requested. Escalate trends to QC management. Recommend process improvements and WID changes as applicable.
5. Implement and maintain new programs within QC as directed to improve reliability of QC function including lab incident reporting, OOS processes, and lab data integrity.
6. Coordinate QC retesting of lots on NCR or CAPA. Verify that retesting requests
7. Track and trend positive environmental swab results from QC areas. Escalate trends to QC management.
8. Liaise with HSE to schedule routine safety audits. Report findings to QC managers and directors. Follow-up on recommended QC actions to improve safety.
9. Track and trend QC employee injuries. Follow-up on HSE recommended QC actions to improve employee safety.
10. Assist QC Managers with the completion of job hazard assessments as needed.
11. Perform other duties as assigned

Supplemental Data:

• This position has no supervisory responsibilities.
• This position reports directly to the Director of QC but has no managerial responsibilities.
• This position is required to work the administrative schedule and is required to maintain regular weekly contact time with all shifts in QC including night shifts.
• No work from home arrangement is available for this position.
• Travel to other bioMerieux buildings within SLC may periodically be required.

Training and Education:

Associates degree required, and/or Bachelor's degree preferred

Experience:

3 years of applicable experience (e.g. quality control, laboratory, or quality investigations)

Knowledge, Skills, Abilities:

• Well-developed interpersonal communication and team leadership skills, including demonstrated ability to provide written and verbal direction and feedback effectively
• Critical and analytical thinking skills
• Extensive experience with Microsoft communication and file sharing platforms (e.g. Outlook, TEAMs, SharePoint/ OneDrive)
• Training or experience with root cause analysis and writing corrective action documentation
• Experience liaising with external departments or on a cross-functional team
• Some experience with data analysis and charting in Excel
• Knowledge of descriptive and inferential statistics is preferred
• Ability to collaborate deeply with a team and ensure deliverables consider all points of view of the team
• Ability to follow directives from upper management and assist them in the implementation of their vision
• Enthusiasm for and dedication to the improvement of the QC function at bioMerieux-SLC
• ability to learn new skills to execute the responsibilities of the role