Advanced Quality Assurance Specialist

Bio-Techne • Austin, TX

2d • $55,600 - $91,450

About The Position

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

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.
• 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.

Nice To Haves

• Knowledge of cGMP, ISO 13485, MDSAP, IVDD/IVDR and FDA QSR preferred.

Responsibilities

• Provides support ensuring compliance with all regulatory standards, systems, procedures, and practices. Includes 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.

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
• an accrued leave policy with paid holidays, paid time off, and paid parental leave.

What This Job Offers

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