Senior Quality Assurance Specialist

Advanced Cell Diagnostics, Inc.; Newark (CA); On-site; USD 89,000 - 147,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) and ESPP

Health Savings Account (HSA)

FSA and dependent care

Tuition reimbursement

Employee resource groups

Paid holidays and PTO

Job summary

Bio-Techne is seeking a Quality Assurance Specialist to ensure that quality requirements are met and to support continuous improvement. The role involves document control, internal audits, CAPA management, and validation activities to uphold ISO 13485 and FDA Quality System requirements.

Strong communication, analytical, and organizational skills are required, with a background in a related science or engineering field and at least 3 years in QA.

Qualifications

• Strong QA experience in a regulated environment.

Responsibilities

• Document control activities in an electronic database.
• Conduct internal audits per plan.
• Prepare audit reports and findings.
• Assist with batch record review and release.
• Review nonconformances and CAPAs.
• Prepare and host CAPA Review Board meetings.
• Monitor QA indicators for management reviews.
• Write validation plans and reports.
• Execute validations.
• Edit QA SOPs and procedures.
• Support other QA duties as needed by QA management.

Skills

Document Control

QA regulations

Verbal & written comms

Lead auditor

CAPA processes

Microsoft Excel

Education

B.S. in a related science/engineering

Tools

Electronic database

Microsoft Excel

Word

PowerPoint

Job description

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

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. To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property. This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status). If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact [e-mail] for assistance. Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services. Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.