- Audits and reviews quality data quality according to existing documents and procedures
- Manages, leads or participates to varying degrees in QA functions defined by ISO/IEC:17025, ISO/IEC:9001, DoD QSM, TNI Standards, and state specific requirements, as relevant to the site
- Maintains the Quality System
- Participates in review of investigations, impact assessments, and other specialized reviews and reports
- May participate in customer audits and answering customer questions or resolving customer concerns
- Prepares and/or reviews and approves department SOPs, worksheets, and data forms
- Has working knowledge and experience in own discipline
- Performs daily reviews of aspects of the quality system and operational activities
- Performs training, including data integrity, quality systems, QC training, and other training as required
- Performs laboratory and systems audits per assigned schedule
- Participate in external audits from clients and regulatory agencies
- Assists in maintaining regulatory certifications
- Reviews and issues client reports in various electronic formats
- Reviews PT results and reviews corrective actions as required
- Assigns and archives logbooks for the laboratory and maintains inventory of logbooks as required (site specific)
- Participates in review and/or processes annual MDL/LOD/LOQ Studies
- Participates in aspects of managing PT samples and in-house blind QC samples
- Maintains records of PT performance (site specific)
- Maintains and updates QAPP worksheets (site specific)
- Other QA duties as required
- Bachelor's degree in science, or equivalent years of experience Required
- 3+ years of experience in a regulated commercial lab environment Required
- Knowledge of scientific principles and of state regulations and ISO and TNI Standards (Required)
- Oral and written communications Skills: Advanced
- Self-initiative and Resource Utilization: Advanced
- Language Skills: Advanced
- Mathematical Skills: Advanced
- Reasoning Skills: Advanced
- Solid critical thinking skills to anticipate and solve problems in a systematic manner
- Advanced computer skills in Microsoft Office suite required (Required)
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Quality Assurance Officer - Clackamas, United States - SGS
Description
Company DescriptionCompany Description
SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services.
Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.
Job Description
POSITION SUMMARY
The Quality Assurance Officer is responsible for aspects of data quality, integrity oversight, and for ensuring quality systems are functioning within QSM requirements and regulatory compliance, corrective action implementation for the location, ensuring all quality systems are functioning within QSM requirements and regulatory compliance. The Officer participates in internal audits and other aspects of ensuring the Quality System. The officer reviews routine and validation testing.
JOB FUNCTIONS
EDUCATION AND EXPERIENCE
Additional information
SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.
This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.
If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call for assistance and leave a message. You will receive a callback. Please note, this phone number is not for general employment information but is only for individuals who are experiencing difficulty applying for a position due to a disability.
