4 QA Specialist Jobs in Seattle, WA
Lumen Bioscience, Inc. is Hiring a QA Specialist Near Seattle, WA
- Conduct facility and operations walkthroughs, observations, and process audits to ensure compliance with the Company’s pharmaceutical cGMP quality system.
- Support Clinical, Development, R&D, and QC operations in developing, executing, and/or transferring GMP processes.
- Assist with and coordinate preparation for and execution of internal and 3rd party audits.
- Create, review, and edit process documentation (procedures) to contribute to continuous improvements in safety, quality, and efficiency.
- Label generation, issuance, and reconciliation, including the development of new labels for future projects.
- Assist with and coordinate the execution of deviations, quality events, investigations, assessments, CAPAs, and change controls.
- Assist with and coordinate the execution of GxP Validation, Qualification and Verification activities for equipment, facilities, process, cleaning, and supplier activities.
- Coordinate with on-site staff and external parties in the execution and completion of day-to-day tasks.
- Assist with eQMS and LIMS build out and maintenance.
- Maintain accurate records of activities.
- Other duties as assigned.
- 6 years of work experience directly in quality assurance in a regulated (GxP) organization and a bachelor’s degree in with an emphasis in quality assurance, quality engineering, microbiology, biochemistry, or related sciences
- Master’s degree with an emphasis in quality assurance, quality engineering, microbiology, biochemistry, or related sciences plus 4 years of work experience directly in Quality Assurance
- Knowledge of relevant cGMP, ISO 9001, and ICH requirements for document control and quality records including, but not limited to, deviations, quality events, investigations, assessments, CAPAs, change controls, qualification, validation, and verification activities.
- Well-organized and detail-oriented with strong technical skills, excellent written and verbal communication skills, and proven ability to manage multiple tasks contemporaneously.
- Strong interpersonal skills and the ability to effectively collaborate with others in a dynamic team environment.
- Capable of supporting multiple projects simultaneously in a deadline-driven environment
- Adaptability, flexibility, independence, and resourcefulness to thrive in a fast-paced, small-company environment.
- High level of proficiency in Microsoft Word, Excel, and SharePoint.
- High integrity and ethics
- Commitment to quality and timely delivery of results
- Sit for extended periods of time (2 or more hours)
- Occasionally lift or carry up to 20 kg
Job Summary
Full Time
Scientific Services
$97k-117k (estimate)
05/31/2024
07/30/2024
lumen.bio
SEATTLE, WA
50 - 100
2017
Private
BRIAN FINROW
$5M - $10M
Scientific Services
Related Companies
About Lumen Bioscience, Inc.
Lumen is a biopharmaceutical company that discovers, develops and manufactures biologic drugs and vaccines for prevalent diseases.
The job skills required for QA Specialist include Quality Assurance, ISO, Continuous Improvement, Auditing, Change Control, Quality Management System, etc. Having related job skills and expertise will give you an advantage when applying to be a QA Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by QA Specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for QA Specialist positions, which can be used as a reference in future career path planning. As a QA Specialist, it can be promoted into senior positions as a Quality Assurance Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary QA Specialist. You can explore the career advancement for a QA Specialist below and select your interested title to get hiring information.
If you are interested in becoming a QA Specialist, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a QA Specialist for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on QA Specialist job description and responsibilities
Primarily, their job responsibilities includes evaluating adequacy of quality assurance standards.
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They devise sampling procedures and directions for recording and reporting quality data.
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Plan, conduct, and supervise test and inspection of materials and products to ensure quality is maintained.
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Analyze data to identify areas for improvement in the quality system.
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Develop, recommend, and monitor corrective and preventive actions.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on QA Specialist jobs
Quality assurance specialists ensure production processes follow established regulations and quality standard.
04/04/2022: Canton, OH
Quality assurance specialists need to outline quality assurance policies and procedures, making sure that quality standards are assured.
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Every QA team follows a process to have a bug tracking tool like Jira, bugzilla.
02/09/2022: Rock Hill, SC
Know how to ask the right questions, and when to ask them.
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Assure ongoing compliance with quality and industry regulatory requirements.
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Step 3: View the best colleges and universities for QA Specialist.
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