Position: Quality Control Scientist
Class: Exempt
Reports to: Quality Validation Specialist
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 Control Scientist position will report to senior leadership within the Quality department. This position will be a subject matter expert for the assays that are being run within the Quality Control department. The ideal candidate will perform validation studies on assays and work to optimize assays as needed. The candidate will craft stability studies and manage the testing and interim and final reports that will go to internal and external customers. The Quality Control Scientist will take a lead in any investigation pertaining to out of specification that should occur in the quality department. Good communication skills both written and oral are a must in this position.
Key Responsibilities
-Design, create, and implement new processes and procedures within the -Quality Control department
-Develop new analytical methodologies and processes for incoming raw material release
-Develop and implement specification justifications and associated validation or equivalency justification reports
-Develop, create, and revise new processes and procedures for in-process and final release evaluation criteria
-Develop, create, and implement statistical process control for all testing within the Quality Control department
-Train Quality Control staff to transfer processes and procedures to routine testing and release processes
-Create and manage stability testing protocols, interim and final reports for both GeminiBio products as well as customer products
-Support the Quality Control department as a subject matter expert for analytical testing and processes
-Manage all new analytical or process development activities within the Quality Control department
-Ensure all projects are properly scoped for resources and time and ensures that most up-to-date status is readily available
-Ensure all required maintenance procedures are created and documented for any new analytical method or process for use in the QMS
-Ensure all required documents for an associated analytical or process development activity is properly tracked, stored, and valid for use in the QMS
-Design and create IQ/OQ/PQ and calibration protocols within the Quality Control department for analytical equipment
-Work and communicates effectively across departments to implement analytical and process improvements within the Quality Control department and to maintain their effectiveness
-Coordinate with QA and QC management to find resolutions for issues related to laboratory investigations
-Maintain thorough knowledge and understanding of all Standard Operating procedures (SOPs) pertaining to testing, review, and equipment calibration and maintenance.
-Conscientiously learn requirements of the ISO 13485 quality management system and 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 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 3+ years in an analytical laboratory role within an ISO-regulated environment
-Demonstrated experience creating new analytical methods and procedures within a regulated environment
-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
-Demonstrated experience creating IQ/OQ/PQ documentation
-Demonstrated experience creating new analytical methods or process improvements in a regulated environment is preferred
-Demonstrated experience managing a multi-faceted project and meeting all required deliverables is preferred.
-Certified Lean Six Sigma Green Belt or Black Belt is preferred
Benefits and Compensation
Salary range $70,000-85,000 based on experience.
GeminiBio provides a competitive benefits package.
EEO STATEMENT
GeminiBio 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.
