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,…