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About the Role

The Senior Quality Assurance Specialist will work closely with internal colleagues as a key member of the Quality Assurance team, maintaining and continuously improving Asuragen’s Quality Management System in alignment with international quality and regulatory standards.

Responsibilities

Lead support for compliance with all regulatory standards, systems, procedures, and practices, including ISO 13485, FDA QMSR, MDSAP, IVDR, and other requirements relating to Quality Assurance activities.
Execute QA production reviews, approvals, and product release.
Act as QA lead representative in new product design and development teams.
Lead external audits, summarizing the results and providing summaries for Quality management.
Execute Document Control, Training, and QA Production related quality system activities.
Lead the management of Training, NCR, CAPA, Complaints, Internal Audits, and Supplier Management quality systems, being responsible for one or more of these systems.
Review and approve validation activities.
Review and approve controlled equipment calibrations and maintenance records.
Support QA management in managing and driving Quality Objectives and Goals.
Lead Quality Management Reviews, identifying and communicating risks to management with proposed mitigation plans.
Create and conduct training for new QA team members.
Perform other duties as assigned.

Requirements

Bachelor’s degree in a related field from an accredited four-year college or university & 7-10 years of experience in a regulated manufacturing facility, or a combination of educational and applicable work experience.
Master’s degree in a related field from an accredited four-year college or university & 4-6 years of experience in a regulated manufacturing facility, or a combination of educational and applicable work experience.
Skilled in the use of software programs such as Microsoft Office and database management programs.
Detail oriented and skilled at examining documents for accuracy and completeness.
Ability to prepare records in accordance with instructions.
Knowledgeable in QA principles and concepts in a dynamic manufacturing facility.
Ability to work in a fast-paced environment.
Ability to set priorities and meet deadlines on a personal level.
Ability to work under tight deadlines.
Capability to effectively train employees on procedures, processes, and QA concepts.
Team oriented individuals with the ability to work effectively with multiple skill level employees.
Skilled at dispute resolution.
Excellent written and oral communication skills.
Excellent analytical and problem-solving skills with the ability to work independently with minimal supervision.
Familiarity with statistical tools and concepts and their application in a regulated environment.
Ability to lead projects with cross-functional teams.
Ability to lead audits and reviews of processes.
Knowledge of molecular science fundamentals, cGMP, ISO 13485, MDSAP, IVDD/IVDR and FDA QMSR preferred.
Requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States.

Skills

Microsoft Office
Database management
QA principles
Statistical tools
cGMP
ISO 13485
MDSAP
IVDD/IVDR
FDA QMSR
Molecular science fundamentals

Location

United States

Work Type

Full-time

Experience Level

Senior
7-10 years
4-6 years

Education Level

Bachelor's degree
Master's degree

Salary/Compensations

$78,100.00 - $128,500.00

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
Employee stock purchase plan (ESPP)
Health Saving Account (HSA)
Flexible Spending Account (FSA)
Dependent Care FSA
Mentorship
Promotional opportunities
Training and development
Tuition reimbursement
Internship programs
Employee resource groups
Volunteer paid time off
Employee events
Charity drives
Accrued leave policy with paid holidays, paid time off, and paid parental leave.

About the Company

Bio-Techne enables cutting-edge research in Life Sciences and Clinical Diagnostics, providing tools for researchers to further treat and prevent disease worldwide.
Fosters a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

Equal Opportunity

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.
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.
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 hr@bio-techne.com for assistance.