Manufacturing Quality Assurance (MQA) Specialist I

Kashiv BioSciences, LLC•Chicago, IL

27d•Onsite

About The Position

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. Creating a Healthier World through Accessible Biologics: 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.

Requirements

A 4-year Bachelor’s degree, preferably in science or engineering discipline.
0-2 years of quality assurance experience in cGMP pharmaceutical manufacturing environment is required.
Working knowledge of cGMP regulations (21 CFR210/211) is required.
Ability to work independently or in teams both within department and cross-functionally.
Must be able to organize, plan, and manage assigned tasks to bring projects to completion.
Strong communication skills, both written and verbal.
Excellent organizational skills and detail-oriented.
Must have excellent time management skills and the ability to effectively prioritize assignments.
Must be able to coordinate projects and activities with other quality assurance staff.
Excellent computer skills in Microsoft Office applications.
Experience authoring technical reports and creation of templates.
Must be able to utilize technical information appropriately to ensure documents produced are consistently clear, concise, accurate, and complete.

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.
Perform quality assurance walk-through audits of manufacturing, laboratory, and warehouse areas to ensure compliance with cGMP’s and company procedures.
Provide backup for other Quality Assurance Specialist responsibilities.
Assist and provide input as part of a project team to resolve quality and manufacturing issues and identify and implement corrective and preventive actions in a timely manner.
Assist on broad spectrum of projects to support the needs of Quality Management.
Perform other duties and responsibilities as delegated by Quality Management.