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Job Title: MQA Quality Associate

Job Description

The MQA Quality Associate will work on the 2nd shift and contribute significantly to quality assurance processes by performing AQL testing, batch record review and release, managing CAPAs and investigations, and overseeing line clearances. The associate ensures that all equipment is calibrated, cleaned, and raw materials are accounted for while facilitating seamless transitions between batches.

Responsibilities

+ 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 bring samples to the lab per the appropriate protocol or sampling instructions.

+ Demonstrate good understanding of AQL procedures and guidelines after applicable training.

+ Train and perform batch record review during production operations, line clearance and control procedures, IPC testing, scale/balance verification, and other assigned production support duties.

+ Monitor all operations pertaining to manufacturing to ensure adherence to AQST policies and procedures.

+ Conduct routine internal audits and facility walkthroughs to ensure compliance and maintain audit readiness.

+ Initiate and investigate nonconformances, resolving quality issues by partnering with other functions.

+ Author and review Forms, Batch Records, WI, SOPs, 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, partnering with operations, supply chain, engineering, and QC staff.

+ Coordinate the Environmental Monitoring program including scheduling of third-party water testing, sampling, and report generation.

+ Manage short to medium-term quality projects aimed at improving efficiency or compliance profile.

+ Understand the manufacturing schedule and provide quality support to ensure business continuity.

Qualifications

+ Minimum 4-year college degree in the Sciences (biology or chemistry) or equivalent experience.

+ 2+ years in pharmaceutical or other regulated industry, consumer industrial works.

Pay and Benefits

The pay range for this position is $25.00 - $29.00/hr.

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)

Workplace Type

This is a fully onsite position in Merrillville,IN.

Application Deadline

This position is anticipated to close on May 28, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.