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Lead and maintain the AS9100-compliant Quality Management System, conduct audits and inspections, manage QA staff and schedules, investigate customer complaints, produce FAI and inspection reports, implement corrective/preventive actions, train personnel, and ensure product quality across manufacturing.
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This position is a hands-on role within the Synthego Quality organization. The responsibility of this position includes but is not limited to management of the eQMS GMP processes and alignment, including metric development and analysis. Lead risk management initiatives including risk assessment of the Synthego GMP processes and trending of quality data. Provide oversight of training for functional teams, support, and escalate compliance issues to senior management in a timely manner. This role has cross-functional influence that has an impact on departmental performance and broad quality initiatives requiring primary tactical decision making.
What You'll Do
- Provide oversight of the eQMS and GMP processes and alignment by maintaining the QA programs, policies, and procedures to ensure GMP compliance of all Synthego products.
- Quality oversight responsibilities including deviation management, corrective and preventive action plans with interdepartmental teams and vendors to resolve potential product quality issues and escalation to senior management as appropriate.
- Lead the raw materials management that includes review and approval of raw materials and associated deviations/supplier corrective action requests.
- Lead the generation, review and/or approval of master batch records, stability study protocols/reports, specifications, deviations, etc.
- Assess and revise, as needed SOPs for GMP Quality functions and identify opportunities to streamline systems and processes.
- Collaborate with cross-functional teams to implement robust Corrective and Preventive Actions (CAPA), customer complaints, process change control management, Non-Conformance, Validation Master Plan, Risk Management, and Planned Deviation.
- Provide Quality guidance of cGMP for cross-functional groups to ensure compliance with KPI targets including functional QA as required.
- Provide Quality support for robust and transparent Quality Governance review processes such as Material Review Board (MRB) and Complaint Review Board (CRB).
- Support and manage regulatory inspections and Notified Body audits as subject matter expert (SME).
- Promote a Culture of Quality by providing support for the implementation of other quality systems, including department and corporate procedures, to ensure compliance with GMPS, other applicable regulations and standards
- Support Quality Control activities in reviewing and approving protocol reports for method validation and stability Study.
- Manage Quality Assurance team and support professional development of the team members.
- Represent Quality Assurance in cross-functional meetings and/or projects.
- Other duties as assigned.
About You:
- Bachelor's degree in Biotechnology or Life Sciences, plus 7 years experience as a Quality Control Specialist or Laboratory Manager.
Company Perks & Benefits:
- Medical, dental, and vision benefits
- 401k Program
- Paid parental leave
- Flexible paid time off
Synthego Redwood, California, USA Office
Redwood, CA, United States
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