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) Associate Scientist reports to the Quality Validations Specialist within the Quality Department and supports analytical assays and tests performed in the QC laboratory while developing subject matter expertise (SME). This role supports the design and execution of assay validation studies, assists in optimization of existing assays, and participates in the development and execution of equipment qualification protocols (IQ/OQ/PQ) under supervision. In addition, this position supports the execution and monitoring of stability study protocols, including stability testing activities, sample storage and inventory management, and preparation of interim and final reports for internal and external stakeholders. This role also participates in investigations related to out-of-specification (OOS) results and other quality events within the department under guidance. Strong written and verbal communication skills are required, as this position involves cross-functional collaboration and reporting of scientific and technical findings while developing the experience necessary to perform responsibilities independently.
Key Responsibilities
- Support the design, development, and implementation of new processes and procedures within the Quality Control department
- Assist in the development and execution of analytical methodologies for in-process testing and final product evaluation
- Contribute to product specification development, validation activities, and equivalency studies under supervision
- Support specification justifications and associated validation or equivalency justification reports
- Support implementation of statistical process control for Quality Control testing activities
- Participate in method transfers and assist in training QC staff as qualified
- Assist in the preparation and execution of stability testing protocols, including drafting interim and final reports and overseeing the storage and inventory management of stability study samples.
- Support analytical method and process development projects under guidance
- Assist in development and execution of IQ/OQ/PQ and calibration protocols for analytical equipment
- Ensure documentation related to analytical methods and processes is accurate and maintained within the QMS
- Collaborate with cross-functional teams to support analytical and process improvements
- Participate in laboratory investigations and support root cause analysis activities
- Maintain working knowledge of applicable SOPs related to testing, review, equipment calibration, and maintenance
- 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, with 3+ years of experience in an analytical laboratory role within an ISO-regulated environment
- Experience supporting stability studies, including protocol execution, sample monitoring, and report preparation
- Experience supporting the execution of IQ/OQ/PQ protocols and related documentation within a regulated environment
- Experience supporting analytical method development or process improvement activities in a regulated environment is preferred
- Experience contributing to multi-faceted projects and assisting in meeting assigned deliverables is preferred
- Knowledge and understanding of ISO quality system standards (ISO 9001 or ISO 13485) through successful work within a quality management system
- Familiarity with document control and good documentation practices, including creating, revising, and maintaining policies, procedures, work instructions, and forms as needed
- Ability to work in a complex and rapidly growing company
- Ability to develop and deliver communications to provide timely information for action
- Demonstrates 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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