QA Auditor

Job Title:

QA Auditor

Job Description

The QA Auditor plays a key role in ensuring product quality and regulatory compliance on the 1st shift (9:00 a.m.

- 7:30 p.m.). This position conducts critical quality inspections on production lines, performs detailed documentation and data entry, and reviews records to verify adherence to current Good Manufacturing Practices (cGMP) and internal procedures. The QA Auditor supports safe, compliant, and efficient operations by monitoring quality metrics, identifying issues, and partnering with production teams to maintain high standards.

Responsibilities

+ Perform routine line checks, including in-process testing, component verification, bar code operation checks, sample reviews, aseptic monitoring, and end-item inspections.

+ Complete line clearance inspections and review area logs for proper documentation prior to lot processing.

+ Check in all components prior to use in production to verify accuracy, suitability, and documentation.

+ Review and approve production records and associated production paperwork prior to issuance, ensuring all calculations are accurate and complete.

+ Conduct chart reviews, log reviews, product reviews, and document reviews to ensure compliance with procedures and regulatory requirements.

+ Perform batch record reviews for accuracy and compliance with company procedures and cGMP standards.

+ Oversee the documentation of production interventions and ensure interventions are recorded accurately and promptly.

+ Execute area purges in packaging and/or vial wash areas as required.

+ Perform shelf reserve sampling, review test results and reports (including TRRs), and complete all associated documentation.

+ Successfully complete and maintain Manual Inspection Qualification for vial inspections and perform vial inspection activities as needed.

+ Attend required meetings and actively participate in discussions related to quality, compliance, and production.

+ Promote and support a safe and harmonious work environment across production and quality teams.

+ Maintain strict compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), and all company policies.

+ Use time management and project management techniques to handle multiple tasks and priorities within defined time frames.

+ Inspect the work of others, provide constructive feedback, and coach performance to align with company standards and procedures.

+ Apply critical thinking and problem-solving skills to identify quality issues, determine root causes, and support appropriate corrective actions.

+ Effectively articulate and present quality strategies, expectations, and findings to employees, management, regulatory bodies, and customers as needed.

+ Provide motivational support to colleagues and help foster a positive, quality-focused culture.

+ Use appropriate training and instructional methods to teach and guide others in performing quality-related functions, including one-on-one instruction.

+ Work with minimal supervision, demonstrate leadership by example, and build strong internal partnerships with colleagues who provide information, assistance, and support.

+ Perform other duties as assigned or required to support overall quality assurance and compliance objectives.

Essential Skills

+ Associate degree in a science or related field from a regionally accredited institution.

+ At least 1 year of quality assurance experience in the pharmaceutical industry or another highly regulated industry.

+ Knowledge of quality auditing practices and internal audit processes.

+ Understanding of quality compliance requirements related to the manufacturing and production of regulated products.

+ Knowledge of regulatory and development processes, including regulatory cGMP requirements for pharmaceuticals and regulatory inspection requirements.

+ Familiarity with regulatory guidance documents and relevant audit schemes.

+ Proficiency with general computer functions, including Microsoft Office applications and spreadsheets.

+ Demonstrated skill in handling multiple projects or tasks simultaneously within defined time frames.

+ Strong quality and compliance vigilance with attention to detail in documentation and review activities.

+ Ability to recognize actual or potential safety issues and respond appropriately (safety sensitivity).

+ Ability to inspect the work of others and coach performance according to standard operating procedures.

+ Ability to apply critical thinking to evaluate data, identify discrepancies, and support decision-making.

+ Advanced interpersonal and communication skills, both written and verbal.

+ Ability to effectively present and explain quality strategies and requirements to diverse audiences, including internal teams and external stakeholders.

+ Ability to work with minimal supervision and demonstrate initiative and accountability.

Additional

Skills & Qualifications

+ Skill in time management techniques to organize personal tasks and support efficient workflows for others.

+ Advanced project…