Manufacturing Quality Associate

Job Title: MQA Associate

Job Description

The MQA Quality Associate supports 2nd / 3rd-shift manufacturing and packaging operations by performing AQL testing, batch record review and release activities, line clearances, and quality oversight in a cGMP pharmaceutical environment. This role helps ensure that each batch meets quality standards, equipment remains properly calibrated, raw materials are accurately accounted for, and all operations comply with internal procedures and regulatory requirements. The position offers strong development opportunities within quality, exposure to new products, and the chance to take on project ownership and leadership responsibilities in a growing organization.

Responsibilities

• Perform AQL (Acceptable Quality Limit) sampling during packaging of finished products according to defined sampling instructions.
• Conduct AQL testing by verifying pouch and strip appearance, weight, dimensions, print presence on strip and pouch, and seal integrity for each sample pulled.
• Accurately record and document results from each AQL test performed in accordance with cGMP and internal documentation standards.
• Communicate AQL alert, action, or failure limits promptly to Quality Assurance and Operations leadership.
• Segregate impacted product populations based on AQL testing results and clearly communicate criteria and instructions to Operations Supervisors and packaging operators.
• Perform stability sampling, finished product sampling, microbiological and in-process sampling, and deliver samples to the laboratory in alignment with protocols and sampling instructions.
• Demonstrate a strong understanding of AQL procedures and guidelines following applicable training and maintain adherence to these procedures.
• Carry out additional duties as assigned by QA Supervisors to support overall quality operations.
• Train and perform batch record review during production, ensuring completeness, accuracy, and compliance prior to release.
• Execute line clearance and control procedures to verify that equipment, materials, and documentation are properly changed over from batch to batch.
• Perform in-process control (IPC) testing and scale/balance verifications to support production quality.
• Monitor manufacturing operations to ensure adherence to quality policies and procedures, providing guidance and clarification to colleagues to maintain consistent product quality approaches.
• Conduct routine internal audits and facility walkthroughs to verify compliance with internal quality system requirements and to maintain a constant state of audit readiness.
• Initiate nonconformance records and coordinate resolution of quality issues by partnering with cross-functional teams, escalating issues to quality staff as needed for CAPAs and investigations.
• Author and review forms, batch records, work instructions, standard operating procedures, and protocols within an electronic document management system.
• Coordinate the Environmental Monitoring program, including scheduling third-party water testing, performing sampling, and supporting report generation.
• Act as short- to medium-term (3–12 months) project owner for quality improvement projects aimed at enhancing efficiency or compliance.
• Understand the manufacturing schedule and provide timely quality support to ensure business continuity and smooth transitions between manufacturing stages.
• Operate with a strong sense of urgency in a fast-paced environment, making sound, ethical, and high-impact decisions related to product quality and batch disposition.
• Perform real-time review of operational records, including batch records, and assist in obtaining corrections or clarifications as needed.
• Issue and manage logbooks, ensuring proper documentation practices and traceability.
• Use Microsoft Office applications, including Microsoft Excel, to support data entry, documentation, and reporting activities.
• Support lab-related activities as needed, including handling and delivery of samples and coordination with laboratory personnel.
• Demonstrate leadership on shift by raising issues promptly, supporting problem solving on the floor, and contributing to decisions regarding batch record releases and AQL-related concerns.
• Contribute to a culture of continuous improvement and compliance by participating in quality projects, process improvements, and team initiatives.
• Travel between nearby production facilities as required to support quality activities.
• Work flexible hours, including off-hour shifts and weekends, to support production and quality needs.

Additional Skills & Qualifications

• High School Diploma
  • Associate/Bachelor's Degree Preferred
• 2 Years of Quality Testing Experience
• Experience with AQL Testing
• Experience with GMP

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

The pay range for this position is $23.90 - $30.00/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)

This is a fully onsite position in Portage,IN.

This position is anticipated to close on Jul 16, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $24 - $30