Quality Inspector

Rani Therapeutics Inc.; Quality (CA); On-site; USD 60,000 - 80,000; Full time

Job summary

A biotechnology firm in California seeks a Quality Inspector to perform incoming inspections and review manufacturing records. This role requires 2-5 years in quality inspection, knowledge of FDA regulations, and experience in a cGMP environment. The ideal candidate will utilize inspection tools such as MicroVu and Keyence and will participate in quality management activities, including training and metric collection.

Qualifications

• 2-5 years of experience performing inspections and reviews/approvals of manufacturing batch records/inspection records.
• Experience in a Government Regulated Environment (FDA, ISO 13485).
• Knowledge of Microsoft Word and Excel.
• Experience working in a cGMP environment.

Responsibilities

• Perform incoming inspections of materials/parts/products.
• Interpret drawings and specification documents.
• Review and approve manufacturing batch records and inspection records.
• Develop inspection methods using MicroVu and Keyence.

Skills

Attention to detail

Organizational skills

Interpersonal skills

Communication skills

Teamwork

Education

2-5 years of experience in inspections

Experience in a Government Regulated Environment (FDA, ISO 13485)

Computer skills (Microsoft Word, Excel)

Experience in cGMP environment

Tools

MicroVu

Keyence

Job description

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