Quality Assurance Associate

Job Description

Job Description

Job Title: Quality Assurance Associate

Job Description

The Quality Assurance Associate plays a vital role in protecting product integrity and ensuring compliance across all pharmaceutical operations. This position serves as a key link between manufacturing, regulatory requirements, and patient safety by reviewing, monitoring, and documenting processes to ensure alignment with GxP, FDA, and global quality standards. From raw material inspection through final product release, the Quality Assurance Associate helps safeguard the quality of products and reinforces the trust that patients place in them.

Responsibilities

• Assist in the maintenance, tracking, and organization of all quality-related documentation, including SOPs, protocols, investigations, CAPAs, planned deviations, change controls, and related records.
• Maintain investigation and CAPA documentation as assigned while ensuring adherence to company quality policies, SOPs, cGMPs, and established practices.
• Support and participate in investigations, root cause analysis, and Corrective and Preventive Action (CAPA) activities in accordance with the company’s Quality System.
• Track and trend key metrics for open investigations, CAPAs, planned deviations, and other quality events to support continuous improvement.
• Prepare and report monthly metrics related to investigations and CAPAs to Quality department leadership and other relevant stakeholders.
• Actively participate in the review and approval of batch record documentation to support timely quality release of drug product.
• Perform risk assessments to evaluate the safety and efficacy of products and recommend appropriate actions based on findings.
• Assist in the change control management program, including documentation, tracking, and archival of change control records.
• Maintain compliance with company policies, regulatory requirements, quality specifications, safety standards, and sanitation practices.
• Conduct routine audits of processes, identify gaps through structured gap analysis, and support remediation activities.
• Perform quality reviews of documentation and processes to ensure accuracy, completeness, and regulatory compliance.
• Assist with SOP revisions and updates, ensuring that procedures reflect current practices and regulatory expectations.
• Participate in internal and external inspections and audits as needed, providing documentation and support to inspectors and auditors.
• Collaborate with QA colleagues and cross-functional teams, and cross-train in other areas of Quality Assurance as needed to support departmental needs.
• Engage professionally with external parties including quality consultants, quality auditors, regulatory authorities, clients, and customers as part of quality-related activities.

Essential Skills

• Minimum of 3 years of experience in pharmaceutical manufacturing, quality assurance, and/or other FDA-regulated industry.
• Bachelor’s degree in Biological Science, Chemistry, Biomedical Engineering, or a closely related field.
• Hands-on experience with investigations, root cause failure analysis, deviations, CAPA activities, and audit support in a regulated environment.
• Experience with batch record review and product release processes within pharmaceutical or related operations.
• Familiarity with GxP, FDA, ICH, and OSHA requirements and the ability to apply these guidelines in daily work.
• Understanding of laboratory, QC, and QA environments and their roles in supporting product quality.
• Proficiency with Microsoft Office applications, including Word and Excel.
• Strong organizational skills and exceptional attention to detail in documentation and record-keeping.
• Proactive, self-driven, and solution-oriented approach to managing quality issues and process improvements.
• Strong collaboration and stakeholder management skills, with the ability to work effectively across QA, QC, production, and external partners.
• Excellent written and verbal communication skills, including the ability to explain complex compliance concepts to both technical and non-technical audiences.
• Demonstrated critical thinking and risk-based decision-making skills in assessing product quality and compliance.
• Ability to wear required protective equipment, including mask, gloves, gown, hairnet, safety goggles, and other protective wear as needed.

Additional Skills & Qualifications

• Experience working with electronic document management and training management systems.
• Experience with small molecule active pharmaceutical ingredients (API).
• Previous experience in a CMO/CDMO environment and familiarity with CDMO business models.
• Exposure to QA activities supporting QC laboratories and production teams.
• Continuous improvement mindset with the ability to contribute beyond basic compliance requirements.
• Ability to build effective relationships with quality consultants, quality auditors, regulatory authorities, clients, and customers.
• Comfort working on key projects within an established QA team and contributing to long-term departmental growth.

Work Environment

This role is part of a Quality Assurance team of more than six professionals supporting CDMO QC laboratory and production teams at an onsite production, laboratory, and office facility. The position is primarily based in an office environment located above the lab and production areas, with regular interaction and collaboration with teams working in those spaces. Work involves the use of standard office technologies such as Microsoft Office, as well as quality and document management systems. The environment follows strict safety, sanitation, and regulatory compliance standards. Appropriate protective attire, including mask, gloves, gown, hairnet, and safety goggles, must be worn when entering designated production or laboratory areas. The culture emphasizes collaboration, continuous improvement, and long-term growth within the QA department, offering opportunities to contribute to key projects for pharmaceutical customers in the CDMO space.

Job Type & Location

This is a Permanent position based out of Morton Grove, IL.

Pay and Benefits

The pay range for this position is $80000.00 - $90000.00/yr.

Health insurance, 401k, dental, vision, PTO, etc. 10% STI incentive bonus for this role.

Workplace Type

This is a fully onsite position in Morton Grove,IL.

Application Deadline

This position is anticipated to close on Aug 12, 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.