Quality Assurance Specialist
1 day ago
Kindeva Drug Delivery is a leading global contract developer and manufacturer (CDMO) with expertise in delivery platform technologies. We partner with our customers to improve patient outcomes worldwide.
Role Summary
The Quality Control Analyst 2 is a second-level position with training in statistical sampling, inspection, and physical testing of incoming materials for conformance to approved written specifications, SOPs, cGMPs, and FDA regulations.
Key Responsibilities
- Inspect components, assemblies, drug product containers, packaging, and labeling according to approved written material specifications.
- Perform physical testing of assemblies and finished devices according to approved written material specifications, test records, and batch records.
- Create in-process and carton labeling according to approved bill of material documents.
- Follow GMP documentation practices on labeling, logbooks, test records, batch records, and other controlled documentation.
- Understand and utilize ANSI sampling plans.
Basic Qualifications
High School/General Education Development (GED) with three years related experience and/or successful completion of a job-specific training program or equivalent combination of education and experience.
Knowledge of cGMP regulations and documentation principles.
Experience in use of measurement and testing equipment.
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state, or local law.
Job Details
Job Family: Apprentice II
Job Function: Technical Professional
Pay Type: Hourly
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