Advanced Quality Assurance Specialist

## Advanced Quality Assurance Specialist Apply remote type:
In-person locations:
Austin, TXtime type:
Full time posted on:
Posted Yesterday job requisition :
JR102029
** 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:$55,600.00 - $91,450.00
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* Position Summary:

** 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.
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* Key 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.
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* Education and Experience:

*** 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.
** Knowledge, Skills, and Abilities:
*** 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.  
** 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 d.* ### 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…