Quality Control Equipment Specialist
3 days ago
We are a global leader in providing cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services. Our company values empower career development through Learning & Development in-house training and mentorship, facilitating career progression. We create high-performing teams that exceed client expectations regarding quality, scalability, and business unit deliverables.
Job Description
This Quality Control Equipment Specialist role operates as part of a dynamic team to plan, execute, and manage activities required to maintain the testing infrastructure of the QC lab. The team works collaboratively, coaching, and teamwork to provide Quality oversight and expertise to the QC team, supporting a High-Performing Organization. Our Quality Control group ensures all materials used for our products are manufactured, processed, tested, stored, and distributed aligned with our incredibly high standards of quality, meeting all regulatory requirements.
Responsibilities
- Responsible for the qualification, maintenance, and/or integration of the QC systems, in compliance with up-to-date data integrity, regulatory, and industry standards.
- Manage change control processes and mechanisms required to maintain a state of continued compliance for the QC systems and instrumentation.
- Serve as an SME for regulatory and internal inspections and audits.
- Author and revise local SOPs, work instructions, and guidelines.
Requirements
- A bachelor's degree in Engineering, biological science, or a related field.
- 3 years' experience in CSV and/or CQV for laboratory systems and instrumentation. Experience in regulatory audits and working knowledge of biologics analytical methods and specifications, Good Manufacturing Practice (GMP), and data integrity compliance requirements.
- Excellent communication skills, both verbal and written.
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