Quality Systems Manager

Organization
Asuragen, Inc.
Job Location
2150 Woodward St.
Suite 100
Austin, TX 78745
Benefits

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

Key Requirements and Duties:

  • Ensure compliance with all applicable regulations, standards, systems, procedures and practices.  Includes Quality System, cGMP, GLP, GCP, CLIA, ISO, EU and other regulatory standards as applicable.
  • Ability to apply a good working knowledge of cGMP, GLP, CLIA, CE, ISO and other regulatory and standard requirements and agencies as it relates to Quality Assurance activities in manufacturing and testing facility.
  • Manage the day-to-day functions of the QA/EMI group and provide training and supervision to department staff.
  • Manage the continuous improvement of the quality system.
  • Oversees controlled documentation creation, approval, modification and release.
  • Provide guidance to assist in the timely resolution of investigations, deviations, nonconformities and other testing or compliance issues that may arise.
  • Conducts internal and external audits, summarizing the results and providing summary information to management.
  • Review and approval of validations.
  • Responsible for complaint investigation and initial potential medical device reporting and potential recall or field correction assessment.
  • Responsible for the administration of the variance systems and CAPA program; including identification, data generation, summarization, closure and effectiveness.
  • Review and release of products and regulated jobs.
  • Review and approval of product Certificates of Analysis and other labels and labeling.
  • Manage vendor quality including qualification and requalification.
  • Provides support on regulatory submissions.
  • Provide support for all Quality Agreements and Technology Transfer activities.
  • Provide strategic input on compliance issues to Management.
  • Develop and manage appropriate quality metrics for monitoring Quality System effectiveness.
  • Provide oversight and input in the Design Control and risk management processes.
  • Provide oversight on the essential requirements and technical file or dossier development and annual review for CE marked IVDs and CMDCAS submissions.
  • Manage GXP/ISO training.
  • Maintain regulated certifications (Texas, FDA, ISO, CMDCAS, etc.).
  • Lead regulatory and client audits. 
  • Provide technical assistance to Research and Development in developing, testing and documenting new and improved processes.
  • All other duties as assigned
Requirements

Minimum Education/Experience Requirements:

Bachelors/masters degree in a related field from an accredited four-year college or university and 5-10 years experience in a regulated testing 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 instructions.
  • Knowledgeable in QC and QA principles and concepts in a dynamic manufacturing and testing 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, QC 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 and lean six sigma tools and concepts and their application in a regulated environment.
  • Knowledge of cGMP, GLP, GCP, CLIA, ISO, OSHA, CE, IVD required.
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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