What are the responsibilities and job description for the Quality Control Analyst II position at Kindeva Drug Delivery?
Kindeva Drug Delivery (Legacy Meridian Medical Technologies) is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
ROLE SUMMARY
The QC 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, Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and Food and Drug Administration (FDA) regulations. We currently have 2 openings: 1st Shift (5:30am- 2pm) and 2nd Shift (1:45pm- 10:15pm).
ROLE RESPONSIBILITIES
Inspects components, assemblies, drug product containers, packaging and labeling according to approved written material specifications.
Performs physical testing of assemblies and finished devices according to approved written material specifications, test records and batch records.
Creates in-process and carton labeling according to approved bill of material documents.
Follows GMP documentation practices on labeling, logbooks, test records, batch records and other controlled documentation.
Understands and utilizes American National Standards Institute (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.
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