Quality Assurance Specialist
8 months ago
Employment Information
Overview:
When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.
While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.
Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization. Diversity Statement:
Element Bend is hiring for a Quality Assurance (QA) Specialist. The (QA) Specialist role is key to our commitment to high quality and innovative growth. The position will focus on continual improvement and change management while also fulfilling fundamental QA roles. The (QA) Specialist will execute Quality System continual improvement initiatives stemming from customer audits, internal audits, CAPAs, and strategic planning exercises. These initiatives are intended to improve quality, efficiency, productivity and compliance. The (QA) Specialist will work closely and collaboratively with the Quality team, Laboratory and Leadership staff on improvement projects while actively contributing to positive co-worker/customer relationships.
Responsibilities:
- Lead Corrective Action processes in response to customer and internal audits, regulatory inspections, and accreditation assessments
- Monitor the execution of the Change Management process and ensure changes to validated/qualified systems are adequately risk assessed and return the system to a qualified state after change
- Perform QA reviews on issue handling processes (IN/NCR/CAPA) and QA reviews of project protocols and reports
- Assist QA management with changing needs, such as procedure improvements, customer and vendor Quality Agreements, Quality System Metrics, department strategic initiatives, etc
- Ensure ongoing proficiency in the applicable regulations and standards (21 CFR Parts 11, 210, 211, 820; ISO 17025) to aid Element Bend's continuing compliance and work with QA and Operations to close high risk gaps
- Evaluate processes for inefficiencies and facilitate efficiency improvements being driven by lab staff and others by reviewing proposals for compliance and congruence with the Quality System
- 5+ years' experience working within a regulated Quality System/GMP environment
- Bachelor’s degree or higher in a related scientific field
- Broad and detailed knowledge of GMP principles, practices and procedures, preferably in an analytical laboratory environment and with proficiency in data integrity principles
- Highly proficient in Word, Excel, PowerPoint & Outlook
- Proven ability to be a productive, efficient and positive team player
- Passion for quality and continual improvement while maintaining positivity through challenges and imperfection
- Must have a strong attention to detail and a demonstrated professional demeanor
- Proven ability to effectively manage time while working on multiple assignments
- Experience with Computerized Systems/Spreadsheet Validation a plus
- Preferred: Analytical chemistry knowledge
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Company Overview:
Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to ‘Make tomorrow safer than today’.
When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.
While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.
Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.
At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.
All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
“If you need an accommodation filling out an application, or applying to a job, please email Recruitment@element.com”
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