Overview
Quality Systems Specialist Jobs in Irvine, CA at OrthAlign Inc.
Position: QA Metrologist
Class: Non-Exempt
Reports to: QA Manager
Location: 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 QA Metrologist is responsible for ensuring that all equipment is up-to-date and adheres to required preventative maintenance, calibration, qualification, or verification standards. This position will design, create, and/or execute IQ and OQ protocols, following established Standard Operating Procedures. QA Metrologist is responsible for coordinating and managing any third-party vendors that perform preventative maintenance, calibrations, qualifications, or repairs. QA Metrologist Owns asset management, ensuring all assets are tagged into the QMS and adhere to all required due dates for compliance.
Key Responsibilities
Manage all assets on site to ensure the most up-to-date status is readily available
Ensure all required maintenance is performed to keep assets valid for use in the QMS
Ensure all required documents for an associated asset and properly tracked, stored, and valid for use in the QMS
May perform IQ/OQ and calibration protocols
Work and communications effectively across departments to implement QMS improvements and to maintain its effectiveness
Coordinate with QA and QC management to find resolutions for issues related to metrology and laboratory investigations
Maintain and update master calibration list
Review calibration/qualification records supplied by third party vendors
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 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
Associate degree in Biology, Chemistry, Biochemistry, or a related scientific discipline, and 2+ years working in a laboratory role
Bachelor’s degree in biology, Chemistry, Biochemistry, or a related scientific discipline, and 1+ years in a laboratory role
Title: Quality Systems Specialist
Company: OrthAlign Inc.
Location: Irvine, CA
