Quality Assurance (MQA) Specialist I - 2nd Shift

About the Role

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company with operations in the United States and India. We are dedicated to advancing patient care and access to important medicines through our robust infrastructure and highly skilled teams. We are currently seeking a Quality Assurance Specialist to join our team.

Responsibilities

• Perform inspection, sampling, and testing of incoming materials, packaging components, and returned goods following detailed written procedures.
• Ensure smooth flow of raw material and critical material testing through routine follow-up with internal and external laboratories.
• Clean and sanitize ISO 7 areas and ISO 5 Laminar flow hoods as per written procedures.
• Assign and verify expiry dates and retest dates for all GMP raw materials through vendor COA and/or in-house COA.
• Review and release raw materials and critical materials.
• Perform manufacturing batch record review and shop floor activities, including visual inspection, line inspection, receiving QA reserve samples, and compiling data.
• Review documentation supporting batch, laboratory, warehouse, metrology, engineering, and validation activities to ensure compliance with cGMP requirements.
• Assist with quality assurance procedures governing the facility quality event system and ensure compliance with cGMP regulations.
• Perform quality assurance walk-through audits of manufacturing, laboratory, and warehouse areas.
• Provide backup for other Quality Assurance Specialist responsibilities.
• Assist in resolving quality and manufacturing issues and implementing corrective and preventive actions.
• Support Quality Management on various projects and perform other duties as delegated.

Requirements

• A 4-year Bachelor’s degree, preferably in science or engineering.
• 0-2 years of quality assurance experience in a cGMP pharmaceutical manufacturing environment.
• Working knowledge of cGMP regulations (21 CFR 210/211).
• Ability to work independently and in teams, with strong organizational and communication skills.
• Proficiency in Microsoft Office applications and experience authoring technical reports.

Qualifications

• Strong attention to detail and excellent time management skills.
• Ability to coordinate projects and activities with other quality assurance staff.
• Experience with technical documentation and ensuring clarity, accuracy, and completeness.

Benefits

• Medical Insurance (Aetna)
• Prescription Drug Coverage (Rx)
• Virtual Visits (Aetna/Teladoc)
• Health Savings Accounts (HSA)
• Flexible Spending Accounts (FSA)
• Dental Insurance (Aetna)
• Vision Insurance (VSP)
• Life and AD&D Insurance
• Disability Benefits
• Supplemental Benefits
• Legal Services
• ID Theft Protection
• Travel Assistance
• Health Advocate
• Life Assistance Program (LAP)
• Student Loan Assistance Program
• 401K
• Monthly Cell Phone Allowance
• Free Parking (Company Paid)

Schedule

This position is onsite 5 days a week, Shift C (Second Shift): 2:00 PM to 10:30 PM EST.

This position description is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.