Serve as the division Quality Compliance technical SME for production and process controls, including statistical sampling, in-process control checks, manufacturing process flows, and batch record compliance across ITP sites.
The estimated base salary for this position is $112,000 - $140,000 annually. This position may also be eligible for discretionary bonuses.
- Serve as the division Quality Compliance technical SME for production and process controls, including statistical sampling, in-process control checks, manufacturing process flows, and batch record compliance across ITP sites.
- Provide strategic and technical Quality Compliance guidance on production and process controls for sterile preparations, with a focus on manufacturing process controls and their compliance adequacy.
- Provide specialist guidance and independent compliance assessment of visual inspection programs, including inspection methods, qualification, defect classification, acceptance criteria, sampling strategies, investigations, and inspection performance trends.
- Provide specialist Quality Compliance guidance on particulate matter prevention and control, including assessment of particulate sources, monitoring and trending, investigation adequacy, and the effectiveness of site-owned corrective and preventive actions.
- Provide specialist Quality Compliance guidance on container closure integrity testing (CCIT), including review of testing strategies, method suitability and validation, lifecycle controls, investigations, and remediation adequacy, in partnership with relevant site functions and the Sterility Assurance SME.
- Bachelor’s degree in engineering, Pharmacy, Chemistry, Life Sciences, Manufacturing, Industrial Engineering, or related technical discipline
- Nice to have: Advanced degree
- medical and dental coverage
- basic life insurance
- accident insurance
- short-term disability
- long-term disability
Quality SME, Production & Process ControlsNewBaxter International Inc. · Marion, US