Manufacturing Quality Assurance (MQA) Specialist I, II, & III

Kashiv Biosciences • Piscataway, NJ

15d • Onsite

About The Position

Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company dedicated to creating a healthier world through accessible biologics. The Manufacturing Quality Assurance (MQA) Specialist I, II, and III is responsible for supporting and ensuring compliance with current Good Manufacturing Practices (cGMP), Company procedures, and regulatory requirements across manufacturing, laboratory, warehouse, engineering, validation, and quality systems activities. This role provides quality oversight for manufacturing operations, raw material release, batch record review, facility audits, and quality event management to ensure products are manufactured, tested, and released in accordance with established quality standards. The MQA Specialist partners closely with cross-functional teams to promote a culture of quality, drive continuous improvement initiatives, and support the successful manufacture of biologics and biosimilar products. The level of responsibility, technical expertise, and independent decision-making will vary based on the MQA Specialist level (I, II, or III) and corresponding experience.

Requirements

• A 4-year Bachelor's degree, preferably in a science or engineering discipline
• Previous experience for MQA I (0 to 2 years or more), MQA II (2 to 5 years or more), and MQA III (5 plus years) in a cGMP biologics/biosimilars manufacturing laboratory environment is required.
• Working knowledge of cGMP regulations (21 CFR210/211/820) is desired.
• Working knowledge of Deviation, CAPA, Change Control, and Validation/Qualification (IQ/OQ/PQ) is desired.
• Ability to work independently or in teams both within the 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 creating templates.
• Must be able to utilize technical information appropriately to ensure documents produced are consistently clear, concise, accurate, and complete.
• Must be able to read, write, and understand English.
• Safety alertness is required due to working around hazardous equipment and conditions.
• Ability to work flexible hours as needed.
• Ability to work under pressure and meet deadlines.

Nice To Haves

• Certification from professional organizations such as ASQ and ISPE is desired but not required.

Responsibilities

• Performs inspection, sampling, and testing where applicable on all incoming materials, packaging components, and returned goods 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 the ISO 7 area and the 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 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 a broad spectrum of projects to support the needs of Quality Management.
• Perform other duties and responsibilities as delegated by Quality Management.

Benefits

• Medical Insurance - Aetna Prescription Drug Converge | 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
• Value Added Benefits & Services
• Health Advocate
• Life Assistance Program (LAP)
• Student Loan Assistance Program
• 401K
• Monthly Cell Phone Allowance

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level