Quality Engineer
West Sacramento, CA

Post

Position:             Quality Engineer

Class:                  Exempt

Reports to:        Senior Director of Quality

Location:            West Sacramento, CA

 

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.

 

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 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 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 company
  • 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 skills

Preferred 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 principles

 

Benefits and Compensation:

  • Competitive salary based on experience.
  • This role is on-site and based in West Sacramento.  This is a full-time position.
  • Gemini Bio provides a competitive benefits package.

 

Environmental Elements& Physical Demands

  • Employee works in a primarily sedentary office environment with moderate noise levels, controlled temperature conditions, and no direct exposure to hazardous physical substances.
  • Employee is personally responsible for following health and safety guidelines, instructions, and policies.
  • Must possess mobility to work in a standard office setting and use standard office equipment, including a computer; vision to read printed materials and computer screen, and hearing and speech to communicate in person, and over the telephone; must be able to bend, stoop, kneel, reach, push and pull drawers open and closed in the execution of duties.
  • Must be able to sit at computer for long periods of time and have the dexterity to access, enter, and retrieve data using a computer keyboard or calculator, and operate standard office equipment.
  • Must have the dexterity and mobility to facilitate or present information to a group, access, enter, and retrieve data using a computer keyboard or calculator, and operate standard facilitation equipment.

EEO Statement

  • Gemini Bio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
  • This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

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