MQA Associate

Job Description

Job Description

Job Title: MQA Quality Associate

Job Description

The MQA Quality Associate supports third-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.

Essential Skills

• Minimum of a 4-year college degree in a scientific discipline such as biology or chemistry, or equivalent experience in a relevant industry or production environment.
• At least 2 years of experience in a pharmaceutical or other regulated industry is preferred; experience in consumer or industrial regulated environments is also considered valuable.
• Strong working knowledge of cGMPs and the ability to understand and follow Standard Operating Procedures.
• Demonstrated knowledge of quality systems, GMPs, industry standards, and regulatory requirements related to the manufacture, testing, and release of pharmaceutical products.
• Hands-on experience with AQL testing, including sampling, physical testing, and interpretation of alert, action, and failure limits.
• Proficiency in batch record review and documentation practices, including issuing and managing logbooks and performing real-time record checks.
• Experience with quality assurance activities such as nonconformance initiation, audits, and support of CAPAs and investigations.
• Ability to sign off on records and make high-impact, ethical decisions that support both product quality and business needs.
• Strong problem-solving attitude and high personal integrity, with the confidence to raise concerns and escalate issues when necessary.
• Technical proficiency in reviewing and auditing production records, reports, and other GMP-related documentation.
• Ability to work effectively within a team environment and contribute to shared quality and business goals.
• Capability to lead or support project teams focused on quality and process improvement.
• Strong organizational skills and the ability to manage multiple assignments and projects with competing priorities independently.
• Excellent attention to detail and accurate data entry skills for documentation and recordkeeping.
• Effective oral and written communication skills, with the ability to interact across multiple organizational levels.
• Experience with Microsoft Office, including Microsoft Excel, for documentation, data entry, and reporting.
• Basic math skills sufficient for calculations related to sampling, testing, and documentation.
• Comfort working on feet for extended periods in a fast-paced production environment.
• Ability to lift up to 35 pounds as needed for sampling, material handling, or equipment-related tasks.
• Valid driver’s license and ability to travel between nearby production facilities (less than 1 mile) as required.
• Willingness to work off-hour shifts and weekends, including third-shift and flexible scheduling, to support production and quality operations.
• Legible handwriting suitable for completing batch records and other documentation accurately.

Additional Skills & Qualifications

• Experience in a Quality discipline such as quality control, quality assurance, batch record review, AQL testing, auditing, engineering, or process improvement.
• Professional training or certification in a Quality discipline, such as ASQ certifications or Lean Six Sigma, is highly preferred.
• Prior lab experience, particularly in a pharmaceutical or regulated manufacturing environment.
• Experience with environmental monitoring programs, including coordination of third-party testing and sampling.
• Familiarity with electronic document management systems for authoring and reviewing forms, batch records, work instructions, SOPs, and protocols.
• Experience in pharmaceutical manufacturing, packaging, or related regulated production environments.
• Demonstrated ability to lead or coordinate short- to medium-term quality projects (3–12 months) aimed at improving efficiency or compliance.
• Comfort working with new product introductions, including direct-to-consumer products such as melatonin and caffeine formulations.
• Interest in career progression within Quality, including potential to move into higher-level QA or operations roles.
• Ability to operate effectively in a fast-growing organization with expanding product lines and facilities.
• Demonstrated leadership potential, including the ability to make tough decisions regarding batch record releases, problem solving, and escalation of quality issues.
• Willingness to develop skills in owning CAPAs and investigation activities, especially for candidates with a relevant degree.

Work Environment

This role is based in a Quality Control pharmaceutical manufacturing environment that operates under strict cGMP and GLP requirements. The MQA team consists of approximately five team members across multiple shifts, with this position serving as the sixth team member and one of the key quality representatives on second or third shift. The facility is very clean and sterile, with 5 to 6 stations on the production floor dedicated to MQA processes that each batch of drug product passes through. The MQA Quality Associate spends significant time on the production floor performing sampling, AQL testing, and documentation, as well as working in a small office space between floor activities. The role requires being on your feet for much of the shift and working in a fast-paced environment with frequent interactions with production and operations staff. The position follows an off-hour shift structure, including a mid-shift (for example, 12:00 p.m. to 8:00 a.m.) and potential coverage from 4:00 a.m. to 12:00 p.m., depending on schedules, vacations, sick time, and customer sample volume. Flexibility to work weekends and varying hours is necessary to support production demands. The environment requires full gowning and strict adherence to GMP/GLP attire and hygiene practices. The role involves occasional travel between nearby production facilities located within approximately one mile. As the organization is growing, with multiple commercialized products and an expanding pipeline focused on central nervous system diseases and severe allergic reactions, employees benefit from opportunities for advancement, exposure to new direct-to-consumer products, and participation in facility expansion initiatives. The culture emphasizes quality, ethical decision-making, continuous improvement, and providing team members with opportunities to develop leadership and advance into higher-level quality or operations roles.

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 Jun 17, 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 View email address on ziprecruiter.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.