Product Transfer Specialist

Organization
Asuragen, Inc.
Job Location
2150 Woodward St.
Suite 100
Austin, TX 78744
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
  • Lead or assist in technology transfer of processes and products from Development to scale-up and manufacturing by working with cross-functional partners to ensure appropriate verification and validation.
  • Ensure appropriate manufacturing controls and release testing are in place.
  • Ensure all Design Transfer documents are released in coordination with product launch activities.
  • Lead or assist in the development of pFMEA assessment and assure it meets business needs and design control requirements.
  • Establish and drive process improvement projects and technology introductions resulting in improved process efficiency, equipment utilization, and reduced operator errors.
  • Drive improved product quality by identifying manufacturing issues, developing cost-effective solutions, and overseeing successful implementation into production.
  • Adhering to industry guidelines, enhance current manufacturing SOP’s, Work Instructions, and Business processes that facilitate a culture of continuous improvement while maintaining a state of compliance to regulations.
  • Support operations CAPA (corrective and preventative action) and NCR (non-conforming report) closure activities.
  • Work with Operations associates to resolve manufacturing and quality problems related to methods, processes, equipment and product design.
  • Generate or assist in technical reports, technical summaries and procedures as needed to support new product initiatives and improvements to existing products.
    • All other duties as assigned.
Requirements

Bachelors/Masters degree in a related field from an accredited four-year college or university, 2-4 years’ 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.
  • Experience with Design of Experiments (DOEs) is preferred.
  • Familiarity with FDA Quality System Requirements and ISO13485 is required
  • Experience working with product development, quality and regulatory is preferred.
  • Excellent communication (verbal and written) and project management skills are required.
  • Full transparency, open mindedness and accountability are required
  • Adaptability & prudent risk taking is required
  • Strong problem-solving skill sets is 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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