BioSkryb is a venture-backed startup company focused on bringing Revolution in Resolution in single cell genomics. BioSkryb’s core PTA (primary template directed amplification) technology enables even and unbiased coverage of the entire genome during DNA amplification and allows for unprecedented accuracy and uniformity in variant calling. We believe our technology will enable a new generation of single cell and low input DNA genomics applications in diverse markets like PGT (Preimplantation Genetic Testing), Neurology, Cancer Genomics, Microbiome Genomics and Minimal Residual Disease testing.

We are seeking an experienced Quality Engineer to join our exciting, fast-growing, and well-financed company to help establish and implement the appropriate quality systems for the design and manufacture of novel genome amplification applications.

Responsibilities:

  • Provide ongoing quality engineering support throughout the product life cycle for new single cell products based on our core technology, Primary Template Directed Amplification (PTA).
  • Provide support to the R&D and manufacturing teams for the validation planning and transfer activities. Assist teams in determining validation needs and requirements.
  • Provide quality support to engineering change controls, deviation management, and document change management.
  • Assist with the development and implementation of a Quality Management System.
  • Establish a process that ensures adequacy of complaint, non-conformance, and Corrective and Preventative Actions (CAPA) records, investigations, and corrective/preventative actions.
  • Provides quality support in the assessment and qualification of new suppliers and materials including specifications and inspection standards.
  • Conduct quality audits of contract manufacturing partners and suppliers to insure the highest level of product.
  • Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders.
  • Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making.
  • Review verification and validation reports and identify gaps for compliance to internal quality requirements.
  • Establish a dashboard with the appropriate KPI’s.
  • Develop and execute strategies to close quality gaps in an efficient, technical, and compliant manner.
  • Coordinate issue resolution using a risk-based approach.
  • Identify areas and opportunities to improve quality system processes and product issues.
  • Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis.
  • Own and/or coordinate CAPAs and NCRs.

Requirements:

  • Experience applying quality regulations and standards (e.g., 21CFR 820, ISO 13485, ISO 14971, IEC62304, GAMP5, IVDD, ISPE Baseline Guides, IVDR, MDSAP, and ASTM E2500-07 Verification Guideline).
  • Practical experience in design controls, risk management, validation, change control, and supplier quality.
  • Experience with CAPA and failure investigation tools and techniques.
  • Applied experience with quality and statistical analysis tools (e.g., SPC, 6 Sigma, Risk Analysis, FMEA, DOE, and trend analysis).
  • Adaptable to fast-paced, less structured, dynamic work environment with shifting demands.
  • Demonstrated ability to accomplish goals while working across departments.
  • Experience with CLIA Certification.

Experience/Education:

  • 7 years’ experience in quality assurance working in the life sciences or medical device industry with a BS or MS degree
  • Demonstrated experience implementing quality systems in a startup environment.
  • Experience in Genomics, Immunology, Biology, or a relevant field preferred.

BioSkryb, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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