Quality Control Specialist

The Quality Control (QC) Technician will be responsible for contamination control and product testing activities in adherence to FDA, EMEA regulations. This role will be integral to Rani’s product release performing key functions on environmental monitoring, investigation, excursion report, writing and interacting with Contract Testing Laboratories. The QC technician will use the Corrective and Preventive Actions (CAPAs) system to identify and investigate issues that may arise during the manufacturing process. This position is responsible for maintaining accurate and up-to-date records of all quality control testing related activities. Documentation plays a crucial role in ensuring that products meet regulatory and quality standards, and quality technicians must ensure that all documentation is complete, accurate, and accessible. Major Duties and Responsibilities Sample management of environmental samples, product release testing and stability testing. Implement QC testing methods for environmental monitoring, medium growth promotion, sterility testing, endotoxin testing, TOC etc. Responsible for Environmental monitoring equipment maintenance and oversight. Perform visual inspection testing of product intermediates and final product per USP. Execute equipment, process or method validation protocols. Purchasing of lab equipment, consumables. Writing URS for equipment. Shipping of samples to external testing laboratories. Capable of performing reviews/approvals of Quality records. Capable of releasing materials/product to inventory. Inventory management of microbiological media and consumables. Coordination and performance of microbial isolation and identification. Able to write and revise SOP's. Submit change orders and represent QA in meetings for related projects. Assist on NCMRs, deviations, and CAPA investigations. Assist with quality audits. Able to assist in validations. Assist in implementing and trending of quality metrics. Work with Engineering/Quality Engineering on the development of inspection methods/programs. Supports quality assurance engineering with technical support in issues affecting manufacturing or QMS. Communicate effectively and thoroughly to management and peers. Education and/or Job Experience 5+ years of relevant experience in the pharmaceutical or biotechnology industry, and a Bachelor’s degree in science or related fields. Minimum 2 years of cleanroom environmental monitoring sampling and testing program experience. Minimum 2 years of Quality Control testing in a regulated manufacturing environment. Minimum 3 years of cGMP experience in a testing lab in compliance with 21 CFR 210/211, ICH guidelines and specific regulatory authority requirements (FDA, EMA, EU, PIC/S, ISO). Experience with Quality System Regulation 21 CFR 820 and ISO 13485:2016 Quality Management System. Must be familiar with: cGMPs, Part 11 compliance, CAPAs, Agency Audits, Internal/external cGMPs, GLP. Excellent verbal, written, interpersonal, organizational, and communication skills are necessary. Skills and Specifications Attention to detail and organizational skills. Good interpersonal and communication skills. Capable of training others. Ability to work as a part of a team. Ability to multi-task and manage a diverse mix of issues, responsibilities and challenges. Flexible and adaptable to changing environment and priorities.

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