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Quality Assurance Lead Technical Operations
2 months ago
Job Summary:
Sunrise Systems is seeking a highly skilled QA Lead Technical Operations to provide quality assurance support to our Devens site and reporting manager. The ideal candidate will have a deep understanding of quality systems and regulatory expectations, with experience in validation, automation, and quality control.
Key Responsibilities:
- Provide quality assurance support to Devens site and reporting manager through quality review and approval of investigations and corrective actions.
- Make decisions on non-conformance through a deep understanding of quality systems and regulatory expectations.
- Review and approve quality, quality control, validation, and automation-related documents.
- Review and approve standard operating procedures (SOPs).
- Review and approval of validation-related documentation, such as risk assessments, protocols, and test scripts, and summary reports.
- Review and approval of change proposals and associated deliverables, ensuring they meet external regulatory and internal WWQC guidelines and requirements.
- Coach across different departments on investigations, CAPAs, general risk assessments, and validation.
- Self-manage and prioritize work across multiple competing deliverables in a remote working environment.
- Interpret complicated data and make sound decisions independently.
Requirements:
- Bachelor's degree in biological science, engineering, biochemistry, or a related discipline.
- Advanced level of relevant experience in GMP, GCP, or GXP with at least 8 years focused on product quality.
- Active member of ASQ or ISPE.
- Prior experience in QC equipment qualification and project management.
- Knowledge of biotech, bulk drug substance, or finished product manufacturing, medical device analytical testing.
- Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
- Knowledge of electronic systems, including SAP, LIMS, TrackWise, Veeva Vault, and electronic or paper-based batch records.
- Excellent technical writing and oral communication skills.
- Background in problem-solving.
- Knowledge of data integrity principles.
- Proven attention to detail.
- Comfortable working in an FDA-regulated environment.
Working Conditions:
The contractor must be able to come onsite Monday through Friday, 1st shift.
