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Job Summary :
The Complaint Quality Assurance Scientist I (CHU) play a pivotal role in ensuring the overall quality and regulatory compliance of customer complaint investigation processes.
This position involves reviewing, evaluating, and documenting activities and findings as part of our ongoing global quality process.
The incumbent will follow established procedures to enter and submit complaints, ensure supporting documentation is attached, correctly classify complaints, and assign investigators / reviewers.
Additionally, they will design and perform complaint investigations, conduct reviews of complaint trending, and escalate product issues to management.
The CHU will complete various documents as required, represent QA on cross-functional projects, and exercise judgment within defined procedures and practices.
Key Responsibilities :
Enter and submit complaints on behalf of field-based personnel
Ensure supporting documentation is attached to complaints
Correctly classify complaints and assign investigators / reviewers
Design and perform complaint investigations into the Chemistry / Immunoassay product line
Conduct reviews of complaint trending to determine CAPA eligibility
Escalate product issues to management
Represent QA on development, current business, or product improvement projects
Communicate and collaborate with other functions such as Field Service, Call center, manufacturing, R&D, and Post Market Surveillance teams
Utilize data analysis and problem-solving skills to identify and countermeasure common failure issues
Maintain robust documentation and adhere strictly to approved procedures
Gain and utilize basic product technical awareness to facilitate informed evaluation of customer complaints records
Complete all needed records in a timely and accurate manner within Smart Solve (compliant management system (CMS))
Qualifications :
Bachelor's degree in a Science or Engineering related discipline
Minimum 2 years' experience in a laboratory environment or Quality role with previous experience in a CHU environment
Good knowledge of FDA QSR and ISO 13485 requirements
Strong troubleshooting skills
Last updated : 2024-05-20
Full Time
Business Services
$91k-109k (estimate)
05/22/2024
05/23/2024
lancesoft.com
HERNDON, VA
500 - 1,000
2000
Private
DIVYA GANDHI
$200M - $500M
Business Services
LanceSoft is a provider of application development, management outsourcing and data-warehousing services to the aerospace and automotive sectors.
The job skills required for Quality assurance specialist include Quality Assurance, ISO, Problem Solving, Chemistry, Troubleshooting, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality assurance specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality assurance specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality assurance specialist positions, which can be used as a reference in future career path planning. As a Quality assurance 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 Quality assurance specialist. You can explore the career advancement for a Quality assurance specialist below and select your interested title to get hiring information.