Quality Assurance (MQA) Specialist I - 2nd Shift

About the role

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSciences Private Limited in India (together “Kashiv BioSciences”), operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines. Kashiv BioSciences is a fully integrated biosciences company with an expanded and dynamic platform for growth, including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines.

Responsibilities

• Performs inspection, sampling and testing where applicable on all incoming materials, packaging components, and return good following detailed written procedures.
• Ensures smooth flow of raw material and critical material testing through routine follow-up with internal and external laboratories.
• Perform the cleaning and sanitization of ISO 7 area and ISO 5 Laminar flow hood, as per written procedures.
• Assigning and verification of expiry date and retest date for all the GMP raw materials through vendor COA and/or in-house COA.
• Perform review and release of Raw Materials and Critical Materials.
• Perform manufacturing batch record review and shopfloor activities like following AQL, Visual inspection of product, line inspection, receiving QA reserve samples, compiling data, etc.
• Review of documentation supporting batch, laboratory, warehouse, metrology, engineering, and validation activities to ensure they are complete and in compliance with company policies and procedures and cGMP requirements.
• Review of documentation supporting quality event system investigations (e.g., change control, deviations, out of specifications, complaints, etc.) prior to final disposition.
• Assist with quality assurance procedures governing the facility quality event system and ensure compliance with cGMP regulations, customer expectations, and company policies.
• Ensure quality events are appropriately cross-referenced and that completed events are included in batch documentation prior to final disposition