Company 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.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Incoming Inspection/Receiving critical raw material
• Perform and monitor the Environmental monitoring testing
• Assist with facility and process validations, as required
• Perform aseptic Quality Control (QC) operations
• Perform or coordinate facility cleaning, operational maintenance, or QC equipment calibrations or verifications
• Create quality documents (e.g., Certificates of Analysis, Certificates of Origin)
• Assist or lead deviation investigations and closures, out of specification investigations CAPA investigations or closures, and change controls, as needed
• Document all work, as required by cGMPs in a real-time basis
• Abide by all safety requirements, as defined by the company
• 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

Required Education and Experience:

• Bachelor’s Degree and 0 years working in a laboratory role in a regulated environment
• Master’s Degree and 0 years in a laboratory role in a regulated environment

Required Skills:

• 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.
• 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:

• Demonstrated experience leading and developing personnel, including performance management, personnel development, and professional development

Benefits and Compensation:

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

Company Core Values:

• Integrity
• Intensity
• Involvement
• Innovation