Quality Control Associate I
West Sacramento, CA
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.
This Position is Entirely On-Site (Not eligible for Remote/Hybrid Work)
The Quality Control Associate will be responsible for daily execution of tasks associated with producing high quality cell culture products in accordance with cGMPs.
- 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 and 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
- 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.
- Integrity: Doing the right thing – the first time. Honoring and keeping commitments.
- Intensity: Working with speed and focus to deliver the high 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 Education and Experience
- Bachelor’s degree
- Laboratory, validation, or GMP: 3 years (Preferred)
- Aseptic Technique: 1 year (Preferred)
- Quality Control: 2 years (Preferred)
- 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 communication to provide timely information for action.
- Results oriented, enduring targets are met on time and on budget.
- Must demonstrated 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.
- Basic knowledge of Scientific Method.
- Excellent oral and written communication skills.
- Basic math skills, including simple algebra
- Basic knowledge of and adherence to cGMP
- Basic knowledge of chemistry and biology
- Basic knowledge of OSHA Safety requirements
- Good documentation skills
- Ability to lift / move 40 lbs. overhead
- Ability to learn how to operate all types of production equipment
- Ability to read, understand and accurately follow company SOPs and guidelines
- Ability to maintain consistent attendance and punctuality
- Willing to learn new tasks, skills
- Responds quickly to assignments
- Positive attitude
- Displays understanding of and promotes company and customer objectives
- Readily adapts to changing job duties
- Works well in a team environment
- Detail oriented