QA Auditor (Manufacturing)

POSITION SUMMARY

Responsible for ensuring compliance and supporting continuous quality improvement within the production area. This role monitors daily manufacturing activities to ensure adherence to SOPs and cGMP requirements and follows through with appropriate actions, including escalation and enforcement of quality standards.

• OTHER ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
• Observe and monitor in-process production activities to ensure compliance with cGMP requirements
• Verify job setup, line clearance, and startup activities, including completion of required checklists
• Ensure cleanliness, sanitation, hygiene, and housekeeping standards are maintained in assigned areas
• Perform in-process inspections, sampling, and testing to verify compliance with specifications
• Inspect and monitor in-process materials and finished goods for quality and compliance
• Review batch records and production documentation for accuracy, completeness, and real-time documentation practices
• Audit electronic production records (e.g., PCLE), including checklists, data entries, releases, and rejections
• Accurately record inspection results, process checks, and activities in electronic systems
• Ensure assigned production areas remain in a continuous state of audit readiness (clean, organized, and compliant)
• Work directly with operators to ensure processes align with SOPs, work instructions, and cGMP requirements
• Identify, document, and report quality issues, nonconformances, and deviations in a timely manner
• Initiate or support deviation and nonconformance reporting, ensuring accurate documentation and follow-through of assigned actions
• Support investigations using root cause analysis tools (e.g., 5-Why, Fishbone) and verify implementation of corrective actions at the floor level
• Perform environmental monitoring activities, including swabbing (e.g., allergen, ATP) and sample collection as required
• Collaborate with Production and other departments to resolve quality issues in real time
• Ensure data integrity and accuracy of all recorded quality and production documentation
• Recognize when production activities, materials, or processes do not meet cGMP or quality requirements and place operations on hold for further inspection or QA review
• Exercise authority to stop or hold production, materials, or processes when quality or compliance risks are identified
• Escalate quality or cGMP issues to QA Auditor Lead or QA leadership as appropriate
• Participate in internal audit programs and support external audits as required
• Assist in training new or junior QA auditors
• Provide clear and accurate shift pass-down reports to QA team members and leadership
• Recommend process improvements to prevent errors and enhance product quality
• Perform other duties and responsibilities as assigned
• WORK ENVIRONMENT
• Daily work is on the production floor, standing/walking the majority of the time
• Working around powders and strong odors; use of a particulate mask will be provided when needed
• Duties are performed primarily in a smoke-free environment

Requirements

WHAT YOU BRING (MINIMUM JOB QUALIFICATIONS)

• College degree in a science related field preferred, but not required
• Minimum 1 year of work experience in a manufacturing or cGMP environment, or related experience with 2 years QA experience
• Must possess good computer skills and familiarity with MS Suite, particularly Word and Excel
• Be able to learn quickly in-house computer programs
• Strong communication skills to include the ability to be effective in working with production operators and supervisors
• Must be willing to work overtime or on weekends, as the workload demands
• PHYSICAL REQUIREMENTS
• Frequently required to stand, walk, bend, kneel, crouch, balance, and reach
• Regularly lift and/or move up to 25 kg / 55 lbs.