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Job Title: MQA AssociateJob 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.

Pay and Benefits

The pay range for this position is $22.00 - $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 Portage,IN.

Application Deadline

This position is anticipated to close on Jun 6, 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.