Senior Quality Assurance Specialist

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

Benefits offered by this job

Medical, dental, vision, life

401k and ESPP

Mentorship and career development

Job summary

Bio-Techne is seeking a Sr. Quality Assurance Specialist to ensure quality processes are compliant with ISO 13485 and FDA QSR. You will lead document control, internal audits, CAPA activities, and regulatory reporting while supporting batch record review and material disposition in a laboratory environment.

The role requires 3+ years in QA, strong communication, and experience with nonconformances and CAPA processes. Onsite work in a lab setting with comprehensive benefits is offered.

Qualifications

• BS/BA in science, engineering or related field required.

Responsibilities

• Document Control activities and maintain electronic database.
• Conduct internal audits and prepare audit reports.
• Review nonconformances and CAPAs; participate in MRB/CAR meetings.
• Assist with batch record review and material disposition.

Skills

Document Control

Internal Audits

CAPA

FDA QSR/ISO13485 knowledge

Excel data analysis

Verbal & written communication

Lead Auditor

Education

BS/BA in science or engineering

QA-related certifications (ASQ CQE/CQA)

Tools

Microsoft Office

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 - $146,900.00Position 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 databaseConduct internal audits on a periodic basis according to an established scheduled planPrepare 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 ReviewWrite validation plans and reportsExecute validationsWrite, review and/or revise QA SOPsOther quality related duties as required by QA managementQUALIFICATIONSEducation 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 plusDemonstrated an understanding of QA regulations and best practicesExcellent 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, etcWorking 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.