Quality Inspector
Rani Therapeutics · Fremont, CA · 8 mo ago
Quality AssuranceFull-time
Major Duties And Responsibilities
- Interpret drawings and specification documents.
- Perform incoming inspection of materials/components/subassemblies/finished products following standard operating procedures and using standard inspection tools, including the MicroVu and Keyence.
- Determine inspection sample size based on procedures, specifications, and standards.
- Help develop inspection methods, including automated inspection programs using the MicroVu and Keyence.
- Review/approve executed batch records for manufacturing and inspection records in accordance to QMS procedures and Good Documentation Practices.
- Approve/perform final disposition of materials/components/subassemblies/finished products.
- Assign and apply expiration dating labels to materials/parts/products, as per specifications/quality procedures.
- Initiate Non-Conformance Material Reports (NCMRs) and deviations when discrepancies are observed during inspections and record review process. Report discrepancies and issues to QA Engineering and affected function(s).
- Maintain materials in Quarantine (pending disposition) and MRB (under NCMR and deviations) in order.
- Maintain accurate records as per Document Control procedures.
- Support training of IQC personnel.
- Affiliate with performing environmental monitoring of Controlled Environment Rooms (CERs), as needed.
- Affiliate with Quality in the collection of quality metrics data.
- Interact closely with different functions of the organization.
Education And/or Job Experience
- 2-5 years of experience performing inspections and reviews/approvals of manufacturing batch records/inspection records.
- Government Regulated Environment experience such as FDA and ISO 13485.
- Must have adequate computer experience (knowledge of Microsoft Word, Excel).
- Experience working in a cGMP environment.
Skills And Specifications
- Attention to detail and organizational skills.
- Good interpersonal and communication skills.
- Ability to work as a part of a team and promote a team environment.