Senior Quality Assurance Specialist

Bio-Techne • Newark, CA

2d • Onsite

About The Position

Engages in planned and systematic activities to provide confidence that requirements for quality and quality improvement are being met. The Quality Assurance Specialist recommends revisions to, or creation of, new protocols, policies, procedures and/or systems as a result of analysis. Understands concepts of ISO 13485 and FDA Quality System Requirements.

Requirements

• At least 3 years of experience in a QA function for the Sr. Quality Assurance Specialist role.
• Demonstrated experience with Document Control processes, experience with an Electronic Database a plus
• Demonstrated an understanding of QA regulations and best practices
• Excellent verbal and written communication skills, strong interpersonal skills, and a demonstrated ability to manage multiple activities while maintaining a high level of organization.
• Working experience as a lead auditor.
• Ability to lead nonconforming material investigations, write reports, and determine material dispositions in a timely manner while maintaining compliance.
• Proficiency in CAPA processes and requirements within each phase.
• Strong understanding of IVD product risk management requirements under ISO 14971.
• Ability to write validation protocols and reports.
• Basic understanding of statistical techniques and sample size rationale.
• Capable of evaluating technical and scientific data and reports to determine their validity.
• Proficiency with Microsoft Office Suite, ability to utilize Excel for data analysis and production of charts and tables.
• Production of reports in Word, PowerPoint, etc

Nice To Haves

• a B.S. or B.A degree in a related science, engineering, or a related field.
• Certifications such as ASQ CQE, CQA, or Lead Auditor certifications are preferred.

Responsibilities

• Document Control activities using an electronic database
• Conduct internal audits on a periodic basis according to an established scheduled plan
• Prepare written audit reports and all activities and report findings.
• Prepare quality records and for regulatory inspections.
• Assist with batch record review and release of approved materials or place material on hold.
• Review and/or write nonconformances and CAPAs.
• Prepare and host Materials Review Board and CAPA Review Board meetings.
• Assist with maintaining and monitoring Quality Assurance specific quality indicators.
• Help prepare data for Management Review
• Write validation plans and reports
• Execute validations
• Write, review and/or revise QA SOPs
• Other quality related duties as required by QA management

Benefits

• competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
• employee resource groups, volunteer paid time off, employee events, and charity drives
• an accrued leave policy with paid holidays, paid time off, and paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior