BioPhase Solutions specializes in recruiting top talented professionals for California's Scientific community. We are currently looking for a Quality Analyst to work for a leading Bay Area biotechnology company.
Assist in the development, implementation and/or maintenance of various defined quality systems.
- Works under direction to assist in the development, implementation and/or maintenance of various defined quality systems and/or metrics, including but not limited to standard operating procedures, validation protocols and final reports, FMEA.
- Assists in the implementation and alignment of company-wide quality systems and policy compliance to ISO 9001 and/or ISO 13485.
- Provide quality-related data in support of various quality, compliance, operations and/or supply chain activities.
- May perform tasks to gather data and generate reports to assist in monitoring of key quality metrics that may be incorporated into management reports.
- Collection, analysis, and reporting of quality data.
- Participates in product improvement teams, field failure analysis and other analytical teams responsible for the improvement of products and compliance issues.
- Generate, review and approval of production records.
- Perform internal quality audits in accordance with audit schedule. This includes establishing audit agenda, scheduling audit, executing audit, issuance of audit reports, and verifying corrective actions to resolve any identified nonconformances.
- Review, analysis and process complaints, NCMRs and CAPAs, manage associated logs.
- Generate product labels.
- Interact with suppliers to obtain technical information and certificates of compliance/analysis.
- Conduct/Assist in Employee Quality Management System training when needed.
- Review documents of External Origin.
- Support activities related to Customer Complaints.
- Additional duties as required.
- BS degree in a scientific discipline, and a min of 3 years of quality assurance experience in a FDA regulated environment (medical device preferred).
- Excellent written and verbal communication skills.
- Well-developed inter-personal and teamwork skills.
- Demonstrated ability to multi-task.
- Proficient in MS Office software, including Word and Excel, as well as QMS software.