Quality Inspector

4 days ago

Fremont, California, United States Rani Therapeutics Full time

GENERAL INFORMATION

Position Title:

Quality Inspector (II, III, or Senior)

Department:

Quality Assurance

Reports to:

Quality Engineering

Purpose of the Job

This Quality Inspector position will report to Quality Engineering. Main responsibilities include performing incoming inspections of materials/parts/products and reviewing and approval of manufacturing batch records and inspection records. This position will require to perform disposition of materials/parts/products. As a Quality Inspector, you will also support Quality Engineering with other Quality Management System (QMS) activities, such as assisting with environmental monitoring and quality metrics.

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.
  • Assist with performing environmental monitoring of Controlled Environment Rooms (CERs), as needed.
  • Support 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

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