Production QA Auditor: Quality Compliance & Improvement

ProCaps Laboratories; Henderson (NV); On-site; USD 29,000 - 34,000; Full time

Benefits offered by this job

Medical, Dental & Vision coverage

Paid Time Off

401(k) with Company Match

Life Insurance

Job summary

ProCaps Laboratories in Henderson, NV is seeking a QA Auditor to ensure production compliance with cGMP and SOPs. You will monitor daily activities, perform in-process inspections, document results, and escalate issues to QA leadership.

The role supports investigations, audits, and continuous improvement, collaborating with operators and other departments to maintain audit readiness and product quality in a fast-paced manufacturing environment.

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 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.

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, 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.
• 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 and verify implementation of corrective actions at the floor level.
• Perform environmental monitoring activities, including swabbing 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.

Skills

Communication skills

MS Office

Fast learner

Overtime willingness

Education

Science degree preferred

Tools

MS Word/Excel

Job description

ProCaps Laboratories in Henderson, NV is seeking a QA Auditor to ensure production compliance with cGMP and SOPs. You will monitor daily activities, perform in-process inspections, document results, and escalate issues to QA leadership.

The role supports investigations, audits, and continuous improvement, collaborating with operators and other departments to maintain audit readiness and product quality in a fast-paced manufacturing environment.