Job Title: MQA Associate

Job Description

We are seeking an MQA Quality Associate to join our team on the 2nd shift. This role involves assisting with AQL testing, batch record review/release, CAPAs/investigations, and line clearances, ensuring proper calibration of equipment, cleanliness, and accountability of raw materials.

Responsibilities

• Pull AQL samples during packaging of finished products according to sampling instructions.
• Perform AQL testing by verifying appearance, weight, dimensions of pouch and strip, presence of print on strip and pouch, and seal integrity for each sample.
• Record results from each AQL test performed.
• Communicate AQL alert, action, or failure limits to the Quality Assurance and Operation Supervisor.
• Segregate impacted population criteria based on AQL testing results and communicate criteria to Operations Supervisor and packaging operators.
• Perform stability sampling, finished product sampling, micro and in-process sampling, and bring samples to the lab per the appropriate protocol or sampling instructions.
• Demonstrate good understanding of AQL procedures and guidelines after training.
• Train and perform batch record review during production operations, line clearance, control procedures, IPC testing, scale/balance verification, and other production support duties.
• Monitor all operations related to manufacturing to ensure adherence to AQST policies and procedures.
• Conduct routine internal audits and facility walkthroughs to ensure compliance with internal quality system requirements.
• Initiate and investigate nonconformances, managing projects to resolve quality issues.
• Author and review Forms, Batch Records, WI, SOPs, and Protocols in electronic document management system.
• Investigate assigned product quality complaints utilizing knowledge of manufacturing and quality processes.
• Own CAPA records and action item implementation, ensuring corrective actions are implemented and effective.
• Coordinate the Environmental Monitoring program, including third-party water testing, sampling, and report generation.
• Manage short to medium-term quality projects to improve efficiency or compliance profile.
• Understand the manufacturing schedule and provide quality support for business continuity and seamless transitions.
• Perform real-time review of operational records, including Batch Records, and assist in obtaining required corrections.

Essential Skills

• Quality assurance expertise, including sampling and documentation.
• Proficiency in Microsoft Office.
• Experience in physical testing and batch record review.
• Strong working knowledge of cGMPs and AQL testing.
• Demonstrated knowledge of quality systems, GMPs, industry standards, and regulatory requirements.
• Technical proficiency in reviewing and auditing production records, reports, and GMP-related documentation.
• Ability to work in a team environment and contribute to company goals.
• Ability to lead project teams and handle multiple assignments with competing priorities.
• Excellent organizational skills and high attention to detail.
• Strong oral and written communication skills.

Additional Skills & Qualifications

• Minimum 4-year college degree in the Sciences (biology or chemistry) or equivalent experience.
• 2+ years of experience in pharmaceutical or other regulated industries.
• Certification in quality discipline (ASQ, Lean Six Sigma, etc.) is highly preferred.
• Ability to sign off on decisions impacting business and ensuring ethical standards.
• Problem-solving attitude and high character.
• Basic math skills and ability to lift up to 35 lbs.
• Must have a driver's license and ability to travel between production facilities.

Work Environment

The work environment is a quality control pharmaceutical manufacturing space, requiring comfort with full gowning in a GMP/GLP environment. The facility is very clean and sterile, with 5 to 6 stations on the floor for MQA processes. The role involves being on your feet frequently in a fast-paced environment. This position is part of a team of 5 MQA members across various shifts, with the candidate becoming the 6th member.