Qa Associate

Job Title:

Compliance Associate

The Compliance Associate supports the Quality Assurance department in maintaining and continuously improving a cGMP-compliant Quality Management System (QMS). The role focuses on document control, training administration, regulatory compliance activities, audit support, complaint investigations, and customer documentation requests. The Compliance Associate works closely with cross-functional teams to ensure adherence to internal quality standards and applicable regulatory requirements while driving ongoing continuous improvement initiatives.

• Support the administration and maintenance of the QMS to ensure ongoing compliance with cGMP and internal quality standards.
• Monitor and interpret FDA, state, and relevant certification requirements, and clearly communicate compliance expectations to internal stakeholders.
• Maintain regulatory data, registrations, listings, and compliance records in an accurate and timely manner.
• Conduct routine compliance assessments and assist in identifying risks, implementing corrective and preventive actions (CAPAs), and verifying their effectiveness.
• Participate in internal and external audits, including preparation, documentation, on-site support, and follow-up activities.
• Serve as a primary point of contact for customer requests related to quality, regulatory, and supplier qualification documentation.
• Prepare, review, revise, and maintain quality system documentation, including SOPs, work instructions, and other controlled documents.
• Process, investigate, and track customer complaints while ensuring compliance with applicable quality and regulatory requirements.
• Conduct root cause investigations and coordinate corrective actions with cross-functional teams to address quality issues and prevent recurrence.
• Maintain employee training records and support training compliance initiatives to ensure personnel remain current with applicable requirements.
• Track and manage quality records, including deviations, change controls, CAPAs, complaints, and audit documentation.
• Oversee document lifecycle activities, including creation, review, approval, distribution, archival, and retention of controlled documents.
• Assist in the collection, analysis, and reporting of quality metrics used to evaluate the effectiveness of the quality system.
• Support continuous improvement initiatives within the QA department by identifying opportunities to enhance processes and controls.
• Perform additional quality and compliance-related duties as assigned to support departmental and organizational objectives.

• Experience in Quality Assurance, Compliance, Regulatory Affairs, or a related function within a regulated industry preferred.
• Knowledge of cGMP requirements and quality systems preferred.
• Familiarity with FDA regulations and quality management principles is a plus.
• Experience with document control systems and quality management systems preferred.
• Exposure to CAPA, deviations, complaints, audits, training management, and change control processes.
• Strong attention to detail and excellent organizational skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong analytical and problem-solving abilities, including root cause analysis and data review.
• Proficiency in Microsoft Office Suite and data entry for quality and compliance records.
• Excellent written and verbal communication skills, including clear written correspondence with internal and external stakeholders.
• Ability to work both independently and collaboratively with cross-functional teams.
• Demonstrated sense of ownership, accountability, and commitment to quality and compliance.

• Associate's or Bachelor's degree in Life Sciences, Chemistry, Biology, Regulatory Affairs, Quality Assurance, or a related field preferred.
• Relevant industry experience may be considered in lieu of a degree.
• Experience working in pharmaceutical, nutraceutical, medical device, food manufacturing, or other regulated environments is highly desirable.
• Experience with quality control, finished product review, batch record review, and closing documents is beneficial.
• Familiarity…