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

About the role

The Manufacturing Quality Assurance (MQA) Specialist I, II, and III supports and ensures compliance with current Good Manufacturing Practices (cGMP), Company procedures, and regulatory requirements across various manufacturing, laboratory, warehouse, engineering, validation, and quality systems activities.

Responsibilities

• Performs inspection, sampling, and testing 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.
• Performs cleaning and sanitization of the ISO 7 area and the ISO 5 Laminar flow hood, as per written procedures.
• Assigns and verifies expiry dates and retest dates for all GMP raw materials through vendor COA and/or in-house COA.
• Reviews and releases raw materials and critical materials.
• Reviews documentation supporting batch, laboratory, warehouse, metrology, engineering, and validation activities to ensure they are complete and compliant with company policies and procedures and cGMP requirements.
• Reviews documentation supporting quality event system investigations (e.g., change control, deviations, out of specifications, complaints, etc.) prior to final disposition.
• Assists with quality assurance procedures governing the facility quality event system and ensures compliance with cGMP regulations, customer expectations, and company policies.
• Ensures quality events are appropriately cross-referenced and that completed events are included in batch documentation prior to final disposition.
• Performs quality assurance walk-through audits of manufacturing, laboratory, and warehouse areas to ensure compliance with cGMP’s and company procedures.
• Provides backup for other Quality Assurance Specialist responsibilities.
• Affords assistance and provides input as part of a project team to resolve quality and manufacturing issues and identifies and implements corrective and preventive actions in a timely manner.
• Affords assistance on a broad spectrum of projects to support the needs of Quality Management.
• Performs other duties and responsibilities as delegated by Quality Management.

Requirements

• Education: A 4-year Bachelor's degree, preferably in a science or engineering discipline.
• Experience: 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.
• Knowledge: Working knowledge of cGMP regulations (21 CFR210/211/820), Deviation, CAPA, Change Control, and Validation/Qualification (IQ/OQ/PQ).
• Skills: Certification from professional organizations such as ASQ and ISPE is desired but not required.

Preferred Qualifications

• Specialized Knowledge and Skills: 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.

Compensation

• MQA I Specialist - Base Salary Range and Yearly Bonus (0–2 years or more of manufacturing biologics/biosimilars Quality Assurance experience): $70,000 to $75,000 (dependent on years of experience and fit for the position) with up to an 8% yearly (discretionary) cash bonus
• MQA II Specialist - Base Salary Range and Yearly Bonus (2-5 years or more of manufacturing biologics/biosimilars Quality Assurance experience): $80,000 to $85,000 (dependent on years of experience and fit for the position) with up to an 8% yearly (discretionary) cash bonus
• MQA III Specialist - Base Salary Range and Yearly Bonus (5 plus years or more of manufacturing biologics/biosimilars Quality Assurance experience): $90,000 to $95,000 (dependent on years of experience and fit for the position) with up to an 8% yearly (discretionary) cash bonus

Benefits/Perks

• Medical Insurance - Aetna
• Prescription Drug Converge | RxVirtual
• Visits - Aetna/Teladoc
• Savings Accounts (HSA)
• Flexible Spending Accounts (FSA)
• Dental Insurance - Aetna
• Vision Insurance - VSPL
• 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

Hours

This position is onsite 5 days a week from 9 AM EST to 5:30 PM EST.

Working Environment/Physical Requirements

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

Supervisory Responsibility

No