Position: Quality Control Associate I
Class: Non-Exempt
Reports to: Quality Control Supervisor
Location: Onsite, 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 Associate I is responsible for ensuring process control and product quality by performing environmental monitoring tests, conducting testing, inspecting incoming and outgoing materials, and aiding in identifying, investigating, and resolving Deviations, Nonconformances, and Out of Specification results per cGMP regulations.
Key Responsibilities
- Incoming inspection/Receiving critical raw material
- Perform environmental monitoring testing
- Test product and material per specifications
- Perform aseptic Quality Control (QC) operations
- Perform facility cleaning, operational maintenance, and QC equipment calibrations
- Create and review product labels and manufacturing work instructions
- Assist deviation investigations and closures, out of specification investigations, CAPA investigations and closures, and change controls
- Document all work, as required by cGMPs in real time
- 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
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 and 1+ years working in a laboratory role in an academic or regulated environment
- In some cases, comparable demonstrated competence and experience in the relevant area may be used to substitute in whole or in part for the Bachelor’s degree
- Basic knowledge of descriptive statistics
- 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
- Excellent oral and written communication skills
- Multitask and adapt to changing priorities in a high-pressure setting
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