Quality Control Analyst

Quality Control Analyst

The Quality Control Analyst leads daily quality control activities on first-shift filling and assembly lines, ensuring that products meet all specifications and current Good Manufacturing Practice (cGMP) requirements. This role oversees in-process inspections, documentation review, and quality investigations while serving as a hands-on team lead for Quality Technicians. The position works closely with cross-functional teams to maintain product integrity, support regulatory compliance, and drive continuous improvement across quality operations.

Responsibilities:

• Lead daily quality control activities on first-shift filling and assembly lines to ensure consistent product quality and regulatory compliance.
• Conduct and supervise in-process inspections, line clearance, and visual checks to verify adherence to product specifications and cGMP requirements.
• Review and approve batch records, labels, and specification and test records with a strong focus on accuracy, completeness, and regulatory compliance.
• Coordinate timely sample collection for stability, microbial, and physical/chemical testing to support release and ongoing monitoring.
• Proactively identify, investigate, and resolve quality issues during production, ensuring thorough documentation of deviations, nonconformance reports (NCRs), and out-of-specification (OOS) events in accordance with cGMP and internal procedures.
• Help investigate corrective and preventive actions (CAPA) and coordinate change controls and quality control standards as needed.
• Coordinate and prepare specifications, Certificates of Analysis (COA), Certificates of Manufacture (COM), and other quality-related documents required for operations and release.
• Provide hands-on training, guidance, and support to Quality Technicians on cGMP compliance, Good Documentation Practices (GDP), inspection techniques, and laboratory procedures.
• Collaborate with Quality, Production, and Engineering teams to ensure seamless execution of quality-related activities and effective resolution of quality issues.
• Monitor quality trends and partner with Quality and Production leadership to drive continuous improvement initiatives on the production floor.
• Ensure cleanliness, proper use, and calibration of quality equipment to maintain reliable and accurate testing.
• Report any safety or compliance concerns in laboratory and production environments and support adherence to established protocols.
• Participate in internal audits and support regulatory or customer inspections by providing documentation, explanations, and quality records as requested.
• Communicate test results, quality concerns, and critical findings accurately, promptly, and professionally to supervisors and relevant stakeholders.
• Manage multiple priorities and meet tight deadlines while maintaining high standards of quality and compliance.
• Lead by example, demonstrating strong accountability and ownership of all quality control activities and promoting a positive, quality-focused culture.
• Perform other related quality duties and tasks as assigned.

Essential Skills:

• Bachelor's degree required, ideally in a scientific discipline such as Chemistry, Biology, Pharmaceutical Sciences, or a related field.
• 1–3 years of experience in Quality Control within pharmaceutical, personal care, food, or industrial manufacturing settings.
• Strong knowledge of cGMP regulations and their application in manufacturing and quality control environments.
• Demonstrated experience with batch record review and quality documentation practices.
• Hands-on experience in quality control, quality assurance, and inspection activities in a laboratory or production setting.
• Ability to conduct analysis and testing in support of quality control activities.
• Experience with CAPA processes, including investigation and documentation of corrective and preventive actions.
• Familiarity with standard operating procedures (SOPs) and their role in regulated environments.
• Proven ability to manage multiple priorities and meet tight deadlines effectively.
• Excellent attention to detail with strong time management and organizational skills.
• Clear written and verbal communication skills for documentation, reporting, and cross-functional collaboration.
• Proficiency in Microsoft Office applications, including Word, Excel, and Outlook.
• Ability to mentor and train team members in quality practices and procedures.
• Demonstrated accountability and ownership of quality control activities.

Additional Skills & Qualifications:

• Experience in pharmaceutical, food manufacturing, personal care, medical device, or related regulated industries.
• Background in chemistry, biology, pharmaceutical sciences, or related scientific fields.
• Knowledge of FDA expectations and regulatory requirements for quality systems.
• Understanding of food safety principles and practices, where applicable.
• Experience working in laboratory environments, including familiarity with laboratory techniques and equipment.
• Exposure to quality control in industrial settings, including filling and assembly operations.
• Experience with Certificates of Analysis (COA), Certificates of Manufacture (COM), and specification documentation.
• Ability to promote and support a positive, quality-focused work culture across departments.
• Bilingual skills in English and Spanish are a plus.

Work Environment:

This is a full-time, first-shift role with a typical schedule of Monday through Friday, 7:00 a.m. to 4:00 p.m., with required availability for weekend work and overtime as business needs arise. The position operates in both production and laboratory environments, particularly in filling and assembly areas where adherence to cGMP, safety, and cleanliness standards is essential. The role involves close collaboration with Quality, Production, and Engineering teams on the production floor and in office or lab spaces, using quality control instruments, calibrated equipment, and standard computer applications such as Microsoft Word, Excel, and Outlook. The work setting emphasizes a hands-on, team-oriented culture focused on product integrity, continuous improvement, and regulatory compliance.

Job Type & Location:

This is a Contract to Hire position based out of Romeoville, IL.

Pay and Benefits:

The pay range for this position is $24.00 - $31.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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 Romeoville, IL.

Application Deadline:

This position is anticipated to close on Sep 8, 2026.