Quality Control Scientist

 

 

 

Company Profile

Founded in 1985, GeminiBio serves the global biotechnology industry, from basic research to commercial production, with a focus on helping our customers accelerate the development of life-enhancing biotherapeutics.

The company focuses on producing cell culture products, instruments, and solutions that help customers streamline their discovery, development, and production processes, and by making custom cGMP bioprocess liquids that radically simplify customers’ manufacturing workflows – regardless of batch size.

Located in West Sacramento, California, GeminiBio has two manufacturing facilities, comprising a total of 57,000 square feet. To meet the stringent needs of biotechnology research and production customers, the company’s cell culture sera and bioprocess liquid manufacturing facilities are segregated between animal origin-free cGMP manufacturing and animal component cGMP manufacturing. GeminiBio is an ISO 13485 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820.

 

Position Summary

The Quality Control (QC) Scientist reports to the Quality Validations Specialist within the Quality Department and serves as a subject matter expert (SME) for analytical assays and tests performed in the QC laboratory. This role independently designs and executes assay validation studies, optimizes existing assays, and leads the development and execution of equipment qualification protocols (IQ/OQ/PQ). In addition, this position develops and manages stability study protocols, including overseeing all stability testing activities, sample storage and inventory management, and preparing interim and final reports for internal and external stakeholders. This role also leads investigations related to out-of-specification (OOS) results and other quality events within the department. Strong written and verbal communication skills are required, as this position involves cross-functional collaboration and clear reporting of scientific and technical findings.

 

Key Responsibilities

 

  • Design, develop, and implement new processes and procedures within the Quality Control department
  • Develop new analytical methodologies for in-process testing, and final product evaluation
  • Develop and implement specification justifications and associated validation or equivalency justification reports
  • Implement statistical process control for Quality Control testing activities
  • Train Quality Control staff and transfer new processes and methods to routine testing and release operations
  • Develop and manage stability testing protocols, including preparation of interim and final reports for GeminiBio and customer products, and oversee storage and inventory management of stability study samples.
  • Serve as a subject matter expert for analytical testing and process development within the Quality Control department
  • Manage analytical method and process development projects, ensuring proper resource planning and timeline management
  • Develop IQ/OQ/PQ and calibration protocols for analytical equipment
  • Ensure required documentation, maintenance procedures, and records for analytical methods and processes are properly created, controlled, and maintained within the QMS
  • Collaborate effectively across departments to implement and sustain analytical and process improvements
  • Coordinate with QA and QC management to resolve laboratory investigations
  • Maintain thorough knowledge of applicable SOPs related to testing, review, equipment calibration, and maintenance
  • Understand and support compliance with ISO 13485 and the Company’s quality objectives
  • Perform other duties as assigned

 

Core Competencies

 

  • Customer Centric
    • Consistently aware of how work product impacts customer value and experience and works with intensity to optimize customer value and experience. Able to identify barriers and inefficiencies impacting customer value.
  • Effective Teamwork
    • Keen ability to collaborate with a diverse set of colleagues – often under pressure – to accomplish business objectives and deliver customer value. Able to identify – and correct – the issues degrading the success of teams.
  • Personal Leadership
    • Consistently delivers high-quality individual results, and when problems are encountered, able to be self-reflective and identify new ways of working to accomplish individual objectives. Strong level of personal accountability.  Invests time and energy into professional development. Routinely takes the initiative to solve challenges and capitalize on business opportunities.
  • Planning and Organizing
    • Able to clearly identify the work that needs to be done and the order in which the work needs to be completed to generate the desired result. Consistently able to foresee challenges and barriers to success and then effectively develops – and implements – actions to accomplish objectives.
  • Effective Communications
    • Able to organize thoughts to communicate to colleagues concisely and accurately and, as needed, management. Oral and written communications are professional and appropriate for the setting and the audience.

 

Company Values

 

  • Integrity
    • Doing the right thing – the first time. Honoring and keeping commitments.
  • Intensity
    • Working with speed and focus to deliver the highest quality results – on time.
  • Involvement
    • Embracing unique perspectives and treating others with dignity and respect.
  • Innovation
    • Biased to improve processes and products to better serve customers and improve workflows.

 

Required Skills and Experience

 

  • Bachelor’s degree in Biology, Chemistry, Biochemistry, or a related scientific discipline, and 5+ years working in an analytical laboratory role within an ISO-regulated environment
  • Master’s Degree in Biology, Chemistry, Biochemistry, or a related scientific discipline, and 2+ years in an analytical laboratory role within an ISO-regulated environment
  • Experience designing and managing stability studies, including protocol development, oversight of sample storage, data analysis, and preparation of interim and final reports.
  • Experience creating and executing IQ/OQ/PQ documentation
  • Experience creating new analytical methods or process improvements in a regulated environment
  • Experience designing, executing, and managing analytical method validation and verification studies in a regulated environment, including preparation of validation protocols and reports.
  • Experience managing a multi-faceted project and meeting all required deliverables is preferred.
  • Knowledge and understanding of ISO quality system standards (either ISO 9001 or ISO 13485) required by successfully working within a quality management system
  • Familiarity with document control and good documentation practices, and experience creating, writing, revising policies, procedures, work instructions and forms as needed
  • 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
  • Have good professional judgment and reliability
  • Highly accurate and detail-oriented
  • Knowledge of Microsoft Office products
  • Experience working with information technology, including database software
  • Excellent oral and written communication skills
  • Certified Lean Six Sigma Green Belt or Black Belt is preferred
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