MQA Specialist II

Description

Position Summary

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. 

Essential Duties & 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, 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.
• 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 back up 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.

Requirements

Position Requirements and Qualifications

Education:

• A 4-year Bachelor’s degree, preferably in science or engineering discipline.

Experience:

• 0-5 years of quality assurance experience in cGMP pharmaceutical manufacturing environment is required.
• Working knowledge of cGMP regulations (21 CFR210/211) is required.
• Level I or II will be determined based on years of experience.

Special Skills:

• 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.

Work Environment & Physical Demands:

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. 

Supervisory Responsibility, if any: No

This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.