
Senior Equipment Operations Specialist
1 week ago
As a Quality Manager, you will oversee the quality control operations. Your daily tasks may include:
- Maintaining oversight of equipment lifecycle activities, including procurement, installation, qualification, maintenance, and decommissioning.
- Providing direction to staff supporting equipment.
- Ensuring equipment qualification and maintenance programs align with regulatory requirements, are qualified, and available for laboratory usage.
- Interacting with partner groups to establish internal requirements for equipment.
- Leading equipment validation/qualification efforts through partnering and interaction with QA Validation and IT groups.
- Managing oversight of preventive and corrective maintenance monitoring program.
- Managing oversight of external laboratories' activities and performance monitoring of external testing laboratories.
- Supervising the issuance and approval of Quality agreements and SLAs with contract labs.
- Verifying that procedures reflect current contract lab utilization.
- Identifying and calling out issues at contract laboratories to leadership.
- Sourcing, coordinating, and project managing GMP activities relating to new contract lab introduction.
- Travel may be required in support of external contract laboratory testing activities.
- Performing personnel management functions, including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations.
- Responsibility for automation and associated projects.
The ideal candidate will possess strong communication and interpersonal skills, demonstrate logical troubleshooting and problem-solving skills, have a detailed understanding of equipment qualification and maintenance activities, and ability to communicate effectively with multiple partners.
To be considered for this opportunity, you should have a degree in chemistry, biology, or a related field with 8+ years' proven experience preferably in the pharmaceutical or biotechnology industry and previous supervisory or leadership experience.
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