Position: Quality Assurance Associate I Class: Non-Exempt Reports to: Quality Assurance Manager Location: On-site, 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. Position Summary The Quality Assurance Associate I is responsible for reviewing manufacturing and development Device History Records prior to release and reviewing departmental completed records to ensure compliance to all associated procedures. This position initiates, creates, and revises documentation for departments' document change control requests. The Quality Associate I works with cross functional management to ensure documentation is complete and adheres to Good Documentation Practices in a timely and accurate manner. Key Responsibilities
- Maintain up-to-date knowledge of cGMP (21 CFR Part 820) and ISO13485:2016 regulations, industry and affiliated publications, standards, and guidance
- Review departmental completed records to ensure compliance to all associated procedures
- Review completed manufacturing and development Device History Records prior to product release
- Assist procurement department with purchasing by ensuring purchasing material meets Final Product Specification/Raw Material Specification
- Support and maintain the Supplier Management Program
- Initiate and track requests for document changes, deviations, non-conforming material records, change controls, CAPAs, and complaints for product and material-specific events
- Assign company-wide training in training software
- Initiate and perform quality events (deviations, CAPAs, risk assessments, non-conformances, etc.) for the Quality Assurance Department
- Create Quality documents such as Certificate of Analysis, Certificate of Origin, and TSE/BSE statements as needed
- Maintain an organized filing system of controlled documents, logs, complete Device History Records, guidance documents, and all other documents required by applicable regulations
- Support internal audits and onsite audits of the facility
- Manage equipment calibration and preventative maintenance schedules to ensure the most up-to-date status is readily available
- Ensure all required documents for an associated asset are properly tracked, stored, and valid for use
- Work and communicate effectively across departments to implement QMS improvements and to maintain its effectiveness
- Other duties as assigned by Quality Management
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 science and 1+ year working in a cGMP Quality Management System
- Knowledge and understanding of ISO quality system standards (either ISO 9001 or ISO 13485)
- Familiarity with document control and good documentation practices, and experience creating, writing, revising policies, procedures, work instructions and forms
- Self-motivated who can work in a multidisciplinary team
- Excellent at multitasking and prioritization of tasks
- Strong interpersonal skills to collaborate with other cross-functional partners
- Aptitude to work in a complex and rapidly growing company
- Ability to develop and deliver communications to provide timely information for action
- Must be highly accurate and detail-oriented
- Encourage a quality-first culture
- Knowledge of Microsoft Office products
- Excellent oral and written communication skills