Senior Quality Assurance Specialist

Bio-Techne • Austin, TX

2d • $78,100 - $128,500

About The Position

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

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.

Nice To Haves

• Knowledge of molecular science fundamentals, cGMP, ISO 13485, MDSAP, IVDD/IVDR and FDA QMSR preferred.

Responsibilities

• Lead support for compliance with all regulatory standards, systems, procedures, and practices. Includes 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. Responsible for the management of one or more of these systems.
• Reviews and approves validation activities.
• Reviews and approves controlled equipment calibrations and maintenance records.
• Support QA management in managing and driving Quality Objectives and Goals.
• Lead Quality Management Reviews. Identify and communicate risks to management with proposed mitigation plans.
• Create and conduct training for new QA team members.
• Other duties as assigned.

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, and more.
• employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
• an accrued leave policy with paid holidays, paid time off, and paid parental leave.
• a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior