Senior Quality Assurance Specialist

biotechne; Newark (CA); On-site; USD 89,000 - 147,000; Full time

Job summary

Bio-Techne in Newark, CA seeks a Quality Assurance Specialist to ensure product quality and regulatory compliance, with responsibilities spanning document control, audits, CAPA, and batch-record reviews.

The role requires a BS in science/engineering and a minimum of 3 years in QA, with ASQ CQE/CQA or Lead Auditor certifications preferred. Strong communication and organizational skills are essential for onsite work and cross‑functional collaboration.

Qualifications

• Bachelor’s degree in a related science, engineering, or related field.
• At least 3 years of experience in a QA function.
• ASQ CQE, CQA, or Lead Auditor certifications preferred.

Responsibilities

• Document Control activities using an electronic database.
• Conduct internal audits on a periodic basis according to schedule.
• Prepare audit reports and report findings.
• Prepare quality records for regulatory inspections.
• Assist with batch record review and release or holds.
• Review and write nonconformances and CAPAs; host CAPA meetings.
• Maintain QA quality indicators and data for Management Review.
• Write validation plans and reports; execute validations.
• Write, review and revise QA SOPs; perform other QA duties as required.

Skills

Document control

Internal audits

QA regulations

CAPA

Lead auditor

Data analysis

Excel

Communication

Multitasking

ISO 13485

Education

Bachelor’s degree in science or engineering

ASQ CQE/CQA or Lead Auditor certifications preferred

Tools

Electronic database

MS Office

Job description

Pay Range:

$89,300.00 - $146,900.00

Position Summary:

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.

Key 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

QUALIFICATIONS

Education and Experience:

• Strongly Preferred a B.S. or B.A degree in a related science, engineering, or a related field.
• At least 3 years of experience in a QA function for the Sr. Quality Assurance Specialist role.
• Certifications such as ASQ CQE, CQA, or Lead Auditor certifications are preferred.

Knowledge, Skills, and Abilities:

• 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

Working Conditions:

• Work performed in a laboratory and production environment with exposure to chemicals, reagents, and standard lab equipment.
• Standard schedule hours with occasional variation depending on production needs.
• Onsite work required during standard business hours.

Physical Requirements:

• Ability to lift and handle materials weighing 5-50 lbs.
• Ability to stand, walk, and perform repetitive laboratory tasks for extended periods.
• Manual dexterity required for laboratory equipment and fine measurement techniques.
• Ability to work at a computer for extended periods.

Why Join Bio-Techne:

• We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• We invest in our employees' financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
• We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
• We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
• We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

Bio-Techne is an E-Verify Employer in the United States.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

This position requires work authorization that does not now or in the future require sponsorship of a visa for em