Rani Therapeutics
Quality Specialist – Rani Therapeutics
Base pay range
$45.00/hr – $52.00/hr
Position Title:
Quality Specialist
Department:
Quality Assurance
Reports To:
Quality Engineering
Purpose of the Job:
Supports various areas of the Quality Management System (QMS); performs inspections of parts/materials/products, reviews and approves manufacturing batch records and inspection records, discharges materials, handles equipment calibration/maintenance, environmental monitoring, quality metrics, and SOP updates to maintain compliance with QMS procedures.
Major Duties and Responsibilities
Interpret drawings and specification documents.
Perform incoming inspection of materials/components/subassemblies/finished products following SOPs and using standard inspection tools, including MicroVu and Keyence.
Determine inspection sample size based on procedures, specifications, and standards.
Help develop inspection methods, including automated inspection programs using MicroVu and Keyence.
Review/approve executed batch records for manufacturing and inspection records in accordance with 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; report issues to QA Engineering and affected functions; collaborate with owners to ensure timely action plans.
Maintain materials in Quarantine (pending disposition) and MRB (under NCMR and deviations) in order.
Maintain accurate records per Document Control procedures.
Coordinate IQC priorities and monitor IQC tasks and deliverables.
Support training of IQC personnel.
Handle and ship samples to external testing laboratories.
Assist in coordination of equipment preventative maintenance and calibration; maintain equipment files.
Assist with environmental monitoring of Controlled Environment Rooms (CERs).
Review and update SOPs to ensure compliance with the QMS.
Support Quality in collecting quality metrics data and data monitoring.
Assist QA during quality audits.
Interact closely with different functions of the organization.
Perform other duties as needed to support the Quality Assurance Department and the company.
Education and/or Experience
Minimum of 5–6 years of related work experience, especially performing inspections and approvals of manufacturing batch records/ inspection records.
Experience in a government‑regulated environment such as FDA or ISO 13485.
Proficient computer skills (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 part of a team and promote a team environment.
Seniority level:
Mid‑Senior level
Employment type:
Full‑time
Job function:
Quality Assurance
Industry:
Biotechnology
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Position Title:
Quality Specialist
Department:
Quality Assurance
Reports To:
Quality Engineering
Purpose of the Job:
Supports various areas of the Quality Management System (QMS); performs inspections of parts/materials/products, reviews and approves manufacturing batch records and inspection records, discharges materials, handles equipment calibration/maintenance, environmental monitoring, quality metrics, and SOP updates to maintain compliance with QMS procedures.
Major Duties and Responsibilities
Interpret drawings and specification documents.
Perform incoming inspection of materials/components/subassemblies/finished products following SOPs and using standard inspection tools, including MicroVu and Keyence.
Determine inspection sample size based on procedures, specifications, and standards.
Help develop inspection methods, including automated inspection programs using MicroVu and Keyence.
Review/approve executed batch records for manufacturing and inspection records in accordance with 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; report issues to QA Engineering and affected functions; collaborate with owners to ensure timely action plans.
Maintain materials in Quarantine (pending disposition) and MRB (under NCMR and deviations) in order.
Maintain accurate records per Document Control procedures.
Coordinate IQC priorities and monitor IQC tasks and deliverables.
Support training of IQC personnel.
Handle and ship samples to external testing laboratories.
Assist in coordination of equipment preventative maintenance and calibration; maintain equipment files.
Assist with environmental monitoring of Controlled Environment Rooms (CERs).
Review and update SOPs to ensure compliance with the QMS.
Support Quality in collecting quality metrics data and data monitoring.
Assist QA during quality audits.
Interact closely with different functions of the organization.
Perform other duties as needed to support the Quality Assurance Department and the company.
Education and/or Experience
Minimum of 5–6 years of related work experience, especially performing inspections and approvals of manufacturing batch records/ inspection records.
Experience in a government‑regulated environment such as FDA or ISO 13485.
Proficient computer skills (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 part of a team and promote a team environment.
Seniority level:
Mid‑Senior level
Employment type:
Full‑time
Job function:
Quality Assurance
Industry:
Biotechnology
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