QA Specialist II

Description

SUMMARY:

The Quality Assurance Specialist II is a regular employee in a full-time exempt position at Kashiv BioSciences,

LLC, in Piscataway NJ. This employee will be responsible for supporting Kashiv BioSciences Quality Assurance

management in reviewing, implementing, and managing the quality system to ensure overall product and process

quality. As an integral quality team member, this individual will provide assurance that all products and quality

system processes in the facility are in compliance with cGMP requirements and company policies and procedures.

Assists in the direction and training of other quality team members.

Position involves reviewing and assembling batch documentation, issuing and tracking controlled documents,

reviewing raw material documentation and releasing material, reviewing deviations, CAPAs, chance controls,

validation/qualification, facility preventive maintenance and calibration records. Position also involves the

completion of manufacturing clearance activities to ensure requirements are met prior to and upon completion of

manufacturing activities and to serve as the witness for critical steps in manufacturing records and quality control

documents.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Manage a broad spectrum of projects to support the needs of Quality Management.
• Issue, assembly and review of documentation supporting batch, laboratory, warehouse, metrology, engineering and validation activities, to ensure complete and in compliance with company policies and procedures and cGMP requirements. Quality system documentation to include SOPs, deviation/investigation reports, equipment/system qualification protocols and reports, change controls, as well as document control activities (training records entries, logbook issuances, logbook archival etc.)
• Interface with cross functional departments Perform quality assurance walk-through audits of manufacturing, laboratory and warehouse areas to ensure compliance with CGMPs and company procedures.
• Quality support of environmental/quality monitoring and release of controlled systems and environments. Support includes data review for release and support of investigation activities.
• 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.
• Perform Raw Material, water and gas sampling, In-process and Finish Product sampling and coordinate submission of samples to QC analysis.
• Receiving of external samples and log in internal quality system
• Quality release of raw materials and finished products.
• Provide back up for other Quality Assurance Specialist responsibilities. Perform other duties and responsibilities as delegated by Quality Management.
• Ensure adherence to GMP good documentation practices
• Complies with all company policies and standards

Requirements

PREREQUISITES:

Education:

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

Experience:

Quality Specialist with Focus in QMS:-  Quality Specialist II

Key Responsibilities: 

• Develop, maintain, and improve QMS processes and documentation 
• Ensure compliance with ISO standards, regulatory, requirements 
• Conduct internal audits and support external audits 
• Manage CAPA (Corrective & Preventive Actions) 
• Handle deviations, OOS, non-conformances
• Understanding of Risk assessment  
• Maintain SOPs, policies, and quality records 
• Drive quality metrics, KPIs, and reporting 
• Provide training on QMS procedures and compliance 
• Support continuous improvement initiatives 

Required Experience

• 3–8 years experience in Quality / QMS roles, if worked in Biologics that would be great or at least pharmaceutical experience. 

Nice-to-Have

• Experience with eQMS tools (Track Wise, Veeva, Master Control, etc.)
• Regulatory exposure (FDA, EMA, etc.)

Cross-functional collaboration experience 

SPECIALIZED KNOWLEDGE AND SKILLS:

• Good communication skills, both written and verbal.
• Good organizational skills and detail oriented. Must be able to effectively manage time to complete assignments.
• Excellent computer skills in Microsoft Office applications.
• 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.
• Direct experience in manufacturing QA support (sampling, room/line clearance, cleaning verification) preferable
• Understand the requirements and procedures related to document control and Quality Assurance.
• Experience in GMP document control
• Must be able to utilize technical information appropriately to ensure documents produced are consistently clear, concise, accurate, and complete.

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

• Typing, desk work and plant auditing.
• Must be able to read, write and understand English.
• Manufacturing clean rooms Some brief and/or minimal exposure to hazardous chemicals may occurs requiring personal protective equipment.
• Safety alertness is required due to work around hazardous equipment and conditions.
• 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.

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.