MQA Associate

We are seeking a dedicated MQA Quality Associate for the 3rd shift from 12pm to 8am. The ideal candidate will be responsible for assisting with AQL testing, batch record review and release, CAPAs and investigations, and line clearances. This role ensures the proper changeover from batch to batch, calibration of equipment, cleanliness, and accounting of raw materials.

• Pull AQL samples during packaging of finished products based on 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 AQL sample pulled.
• 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 the Operations Supervisor and packaging operators.
• Perform stability sampling, finished product sampling, micro and in-process sampling, and transport samples to the lab per protocol.
• Demonstrate a good understanding of AQL procedures and guidelines after applicable training.
• Perform other duties as instructed by QA Supervisors.
• Train and perform batch record reviews during production operations, line clearance and control procedures, IPC testing, scale/balance verification, and other assigned 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 nonconformances and project manage to resolve quality issues by partnering with other functions.
• Author and review Forms, Batch Records, WI, SOPs, and Protocols in the electronic document management system.
• Coordinate the Environmental Monitoring program, including scheduling of third-party water testing, sampling, and report generation.
• Serve as a short to medium-term (3-12 months) project owner for quality projects to improve efficiency or compliance profile.
• Understand the manufacturing schedule and provide quality support to ensure business continuity.
• Operate with a sense of urgency in a fast-paced environment.
• Perform real-time review of operational records, including Batch Records, and assist in obtaining required corrections.

• High School Diploma
• 2+ Years of experience in quality control/assurance, batch record review, AQL testing, auditing, engineering, process improvement preferred.

This is a Contract to Hire position based out of Portage, IN.

The pay range for this position is $23.90 - $33.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Portage,IN.

This…