Quality Engineer

Company: GeminiBio
Location: West Sacramento
Posted on: June 20, 2022

Job Description:

West Sacramento, CAPosition: Quality EngineerClass: ExemptReports to: Director of QualityLocation: West Sacramento, CACompany Profile: Founded in 1985, Gemini Bio is a supplier of cell culture media, sera, and other reagents and instruments to many of the top research and academic institutions as well as biotechnology, cell/gene therapy, and pharmaceutical companies. Gemini Bioproducts, LLC, is a portfolio company of BelHealth Investment Partners, LLC a New York-based healthcare private equity firm. Gemini Bio, which operates in West Sacramento, California, is growth-focused and is expanding and enhancing its manufacturing capabilities driving toward higher quality and compliance standards commensurate with the needs of the commercial therapeutic space. Gemini Bio is augmenting its product portfolio through acquisitions, internal innovation, and partnerships. Key Responsibilities:

• Establishing, maintaining, and improving QMS support processes; and
• Providing effective program coordination of those processes; and
• Applying skills in data analysis, investigations, and auditing to the maintenance and improvement of the QMS.PRIMARY DUTIES AND RESPONSIBILITIES:
  • In partnership with process participants, process owners, and stakeholders, implements, maintains, and improves procedures for the quality management processes under his/her area of responsibility.
  • Works and communicates effectively across departments to implement QMS improvements and to maintain its effectiveness
  • Program coordination for one or more of the following QMS processes: the corrective action and preventive action program, the internal quality audit program, product lifecycle risk management; supplier qualification
  • Participate in the following QMS activities, as assigned: Review and release of manufacturing and QC testing batch records; investigate and document root causes of nonconformances
  • Fulfill QA responsibilities on new product development teams, as assigned, which include: facilitate and document risk assessments; coordinate approval of new suppliers; test method, review, and approval; participate in verification and validation planning and execution
  • Assist in the determination and delivery of quality system training requirements
  • Generate, review, and approve production deviations, complaint investigations, and nonconformance reports for non-conforming materials
  • Review and approve material and product specifications and the acceptance criteria for equipment qualifications and process validations
  • Conscientiously learn requirements of the ISO 13485 quality management system and diligently follow the terms of a quality contract, which describes the relevance and importance of the employee's work to the achievement of the Company's quality objectives
  • Other duties as assignedRequired Education and Experience:
    • Bachelor's Degree in Biology, Chemistry, Biochemistry, or a related scientific discipline, and 3+ years working in a quality role within a biotechnology, medical device, or pharmaceutical company
    • Master's Degree in Biology, Chemistry, Biochemistry, or a related scientific discipline, and 2+ years in a quality role within a biotechnology, medical device, or pharmaceutical companyRequired Skills:
      • Knowledge and understanding of ISO quality system standards (either ISO 9001 or ISO 13485) required, as evidenced by a successful track record in external supplier audit or internal quality audit programs and by successfully working within a quality management system
      • Working knowledge and demonstrated experience using root cause analysis and process troubleshooting tools
      • Familiarity with document control and good documentation practices, and experience creating, writing, revising policies, procedures, work instructions and forms as needed.
      • Basic knowledge of descriptive statistics and its application to sampling plans, specification setting, and process control
      • Aptitude to work in a complex and rapidly growing company
      • Ability to develop and deliver communications to provide timely information for action
      • Results oriented, ensuring targets are met on time and on budget
      • Must demonstrate good professional judgment and reliability
      • Must be highly accurate and detail-oriented
      • Knowledge of Microsoft Office products
      • Experience working with information technology, including database software
      • Excellent oral and written communication skillsPreferred Skills and Certifications:
        • Certifications issued by global quality organizations (e.g., six sigma, lean, auditor), and a continued understanding of the current body of knowledge.
        • Experience leading or completing projects based on the Six Sigma BoK and lean principlesBenefits and Compensation:
          • Competitive salary based on experience.
          • Ongoing production driven incentives and bonuses.
          • This role is on-site and based in West Sacramento. This is a full-time position.
          • GeminiBio provides a competitive benefits package.Company Core Values:
            • Integrity
            • Intensity
            • Involvement
            • Innovation

Keywords: GeminiBio, West Sacramento , Quality Engineer, Engineering , West Sacramento, California