Quality Specialist

Quality Specialist – Rani Therapeutics

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Base pay range: $45.00/hr - $52.00/hr

Purpose of the Job This Quality Specialist position will report to Quality Engineering and support various areas of the Quality Management System (QMS). The role includes performing inspections of parts, materials and products; reviewing and approving manufacturing batch records and inspection records; managing disposition of materials; and supporting QMS activities such as equipment calibration, environmental monitoring, purchasing, shipping samples, quality metrics and SOP updates to maintain compliance with QMS procedures.

• Interpret drawings and specification documents.
• Perform incoming inspection of materials, components, subassemblies, and finished products following standard operating procedures and using standard inspection tools, including the Micro Vu and Keyence.
• Determine inspection sample size based on procedures, specifications, and standards.
• Help develop inspection methods, including automated inspection programs using the Micro Vu and Keyence.
• Review, approve executed batch records for manufacturing and inspection records in accordance with QMS procedures and Good Documentation Practices.
• Approve and perform final disposition of materials, components, subassemblies, and finished products.
• Assign and apply expiration dating labels to materials, parts, and products, as per quality procedures.
• Initiate Non‑Conformance Material Reports (NCMRs) and deviations when discrepancies are observed during inspections and record review processes, and report issues to QA Engineering and affected functions.
• Work with NCMR and deviation owners to ensure that action plans are completed in a timely manner.
• Maintain materials in quarantine (pending disposition) and MRB (under NCMR and deviations) in order.
• Maintain accurate records as 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 coordinating equipment preventive maintenance, calibration, and maintaining equipment files.
• Assist with performing environmental monitoring of Controlled Environment Rooms (CERs).
• Review and update Standard Operating Procedures (SOPs) to ensure compliance with the QMS.
• Support quality in the collection of 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.

• Minimum of 5‑6 years of related work experience, especially in inspections, reviews, and approvals of manufacturing batch records and inspection records.
• Experience in a government‑regulated environment such as FDA and ISO 13485.
• Proficient computer skills, including Microsoft Word and Excel.
• Experience working in a cGMP environment.

• Attention to detail and strong organizational skills.
• Good interpersonal and communication skills.
• Ability to work as part of a team and promote a team environment.
• Prior experience leading a small team of Quality Inspectors is a plus.

Mid‑Senior level

Full‑time

Quality Assurance

Biotechnology