Quality Assurance Specialist

Asuragen, Inc.
Job Location
2150 Woodward St.
Suite 100
Austin, TX 78744

We invest in your well being: health and dental coverage, stock options for every employee, wellness initiatives, disability coverage, 401(k) plan, professional development and more.

Job Description
  • Ensures compliance with all regulatory standards, systems, procedures and practices.  Includes cGMP, GLP, CLIA, CE, ISO, EU and other regulatory requirements and agencies as it relates to Quality Assurance activities in the manufacturing and testing facility.
  • Applies a good working knowledge of cGMP, ISO and other regulatory requirements and agencies as it relates to Quality Assurance activities in a manufacturing environment through support of manufacturing operations including staging, line inspections, batch record issuance, batch record review and material release.
  • Conducts internal and external audits, summarizing the results and providing summaries to Quality Management.
  • Assists in management of the Document Change Control Process, NCR, CAPA, Complaints and OOS systems.  May be responsible for the management of one or more of these systems.
  • Reviews and approves validation activities.
  • Assists in the administration of the CAPA and investigation programs; including identification, data generation, summarization and closure.
  • Assists in the maintenance of controlled documents, including creation, editing, indexing, tracking and storage using the Microsoft Office Sharepoint Server System or other Electronic Document Management System.
  • Reviews and approves quality equipment calibrations and maintenance.
  • Manage the historical files of all manufactured products and archival records including on and offsite storage.
  • Supports regulatory and client audits.
  • Supports the overall Quality goals and QA Department goals.
  • Generates metrics in support of Quality Management Reviews.
  • Software Validation, IVD Software Validation.
  • All other duties as assigned.

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.

Preferable Skills and Attributes:

  • 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, OSHA, CE, IVD preferred.


About Our Organization

Asuragen is a global diagnostic products company delivering solutions that build knowledge and understanding of complex clinical questions. Asuragen’s application of its deep scientific heritage and molecular expertise delivers diagnostic products in oncology and genetics that provide the best answers with optimal workflows – so time can be spent delivering actionable insights, rather than searching for them. With innovative approaches to kit development and a broad range of molecular chemistries, Asuragen produces assays that ensure reproducible results. From discovery and development to regulatory support to global commercialization, we also provide a tailored approach that efficiently delivers custom and companion diagnostic products for our partners. Asuragen is located in Austin, Texas, which is consistently ranked in the top 10 of “best places to live” list of US cities. Asuragen offers a competitive salary, medical, dental, disability and life insurance, a 401(k) plan with company matching contributions, employee stock option plan, and a tuition reimbursement plan.

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