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About the Role

The Advanced Quality Assurance Specialist will work closely with internal colleagues as a key member of the Quality Assurance team, maintaining and growing the Quality Management System in alignment with international quality and regulatory standards.

Responsibilities

• Provides support ensuring compliance with all regulatory standards, systems, procedures, and practices, including ISO 13485, FDA QSR, MDSAP, IVDR, and other requirements relating to Quality Assurance activities.
• Provide QA support to project core teams.
• Provide support to or ownership of key quality management system processes.
• Conducts internal and external audits, summarizing the results and providing summaries to Quality Management.
• Assists in the management of Document Control, Training, NCR, CAPA, Complaints, Internal Audits, and Supplier Management systems; may be responsible for the management of one or more of these systems.
• Reviews and approves validation activities.
• Reviews and approves quality equipment calibrations and maintenance.
• Supports regulatory and client audits.
• Supports the overall QA Department goals.
• Generates metrics in support of Quality Management Reviews.
• Other duties as assigned.

Requirements

• Bachelors/Masters 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.
• 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.
• 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.

Skills

• 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 detailed instructions.
• Knowledgeable in QA principles and concepts in a dynamic manufacturing facility.
• 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 individual 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.
• Knowledge of cGMP, ISO 13485, MDSAP, IVDD/IVDR and FDA QSR preferred.

Location

• United States

Work Type

• Full-time

Experience Level

• 4-6 years of experience

Education Level

• Bachelors/Masters degree

Salary/Compensations

• $55,600.00 - $91,450.00

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, 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.
• Employee resource groups, volunteer paid time off, employee events, and 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.
• Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.
• We foster 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.