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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Senior Specialist, Quality Assurance
Remote, CA US
Posted: 11/26/2024
2024-11-26
2025-01-08
Employment Type:
Contract
Job Category: Quality
Job Number: 4121
Job Description
The primary focus of this role is the support and oversight of Quality Management Systems ensuring key requirements and initiatives are implemented, maintained, and reviewed in accordance with cGMP regulations.
Responsibilities may include:
Responsibilities may include:
- May be responsible for leading and directing the Quality functions for assigned plant(s) or functional area(s)
- Responsible for providing Quality oversight to ensure that systems are executed, according to current Good Manufacturing Practices (cGMP) and other applicable regulations
- Ensures that Quality Management Systems comply with cGMP practices and other applicable regulations
- Provide support for Global Process Owners executing key quality systems processes
- Ensures the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records, including nonconformances, CAPAs, change control records and validations.
- Supports Continual Improvement initiatives, programs and projects
- Ensures that changes that could potentially impact product quality are assessed according to procedures
- Ensures that deviations from established procedures are investigated and documented per procedures
- Collect and analyze Key Process Indicator (KPI) data to assess process performance and areas of improvement
- Alerts senior management of significant quality, compliance, supply and safety risks
- Doctorate degree and 2 years of experience OR Master degree and 6 years of experience OR Bachelor degree and 8 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
- Quality Management Systems experience (up to and including ownership of a quality system element, implementation of a quality system element)
- Regulatory Compliance experience (up to and including experience presenting to a regulatory authority, ensuring GMP processes are aligned to regulations)
- Ability to coordinate with cross functional teams, ability to communicate up and down management chain
- KPI data collection and analysis with presentation to leadership at management reviews
- Strong systems understanding (Microsoft suite, Veeva platform, TrackWise, etc.)
- History of general GMP execution (Deviations, Change Controls, CAPA, Disposition of Product, Regulatory Deviation Reporting, Recalls)