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Batch Record Auditor Jobs (NOW HIRING)

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QA Auditor - Parenterals

Gurabo, PR · On-site

Learn more at We are searching for the best talent for QA Auditor, Parenterals to be located at ... Review batch records, in-process documents, analytical data, and other regulatory documentation to ...

Staffing Synergies

Quality Auditor - Edison

Edison, NJ · On-site

$18/hr

Quality Auditor Location: Edison, NJ Pay: $18/hr Shift: 1st shift - 6:00am-2:45pm 2nd shift - 3 ... Monitor batch records, validation protocols, and ensure proper documentation is completed. What We ...

Innovative Skincare

Quality Auditor

Mesa, AZ · On-site

$22 - $24/hr

About the role: The Quality Auditor is responsible for performing audits of processes ... Review documentation, batch records, and reports for accuracy and compliance. * Inspect finished ...

Innovative Skincare

Quality Auditor

Mesa, AZ · On-site

$22 - $24/hr

About the role: The Quality Auditor is responsible for performing audits of processes ... Review documentation, batch records, and reports for accuracy and compliance. * Inspect finished ...

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How much do batch record auditor jobs pay per hour?

As of Sep 10, 2026, the average hourly pay for batch record auditor in the United States is $38.60, according to ZipRecruiter salary data. Most workers in this role earn between $17.31 and $32.69 per hour, depending on experience, location, and employer.

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QA Auditor I

Miramar, FL • On-site

AVEVA DRUG DELIVERY SYSTEMS INC
See more jobs at AVEVA DRUG DELIVERY SYSTEMS INCexternal

Full-time

Re-posted 3 days ago

Key responsibilities

  • Perform room and equipment line clearance, visual inspection of finished products, and collect samples from the production line.

  • Conduct in-process audits of manufacturing and packaging areas, review batch documentation for compliance, and ensure GMP and cGMP standards are met.

  • Support facility readiness through daily walkthroughs, monitor product defects, and execute QAIP walkthroughs to ensure compliance and quality standards.

Job description

The Quality Assurance In-Process (QAIP) Auditor I is responsible for the day to day support to the Manufacturing, Packaging, R & D, Technical Operations, Engineering and QC operations by

performing room and equipment line clearance, visual inspection of finished products, collecting stability and retain samples from the production line, conducting Packaging, Manufacturing In-process audits to ensure that the Intermediate materials and packaged products conforms to the established quality standards and conducting on-line batch record review in real time. In addition, the QAIP auditors are responsible for daily walkthroughs ensuring that the facility is Audit ready at all times.

Job Responsibilities:

  • Ensure GMP compliance throughout the facility
  • Enforce cGMP regulations and Aveva’s Standard Operating Procedures (SOPs)
  • Maintain knowledge of Production Manufacturing and Packaging SOPs
  • Approve Shipper labels/roll labels, and clinical labels
  • Room and equipment line clearance for the packaging process
  • In-process audit of all areas of manufacturing and packaging; on-line reviewing batch documentation for compliance to batch record requirements and product specifications.
  • Preparation and execution of AQL plans
  • Completion of the QA Envelope Documentation (Room Release, Start up, and executed AQL plans)
  • Perform Evaluation / impound of Substandard Materials
  • Sampling products for on-line inspection, AQLs, stability, Reworks, Controlled Substance, etc.
  • Monitor the In-Process product defects Tracking, Trending Assessment
  • Monitor the Preparation of the Product Defect Samples for the Defect Library
  • Conduct  surface swab sampling and swab release based on swab test results
  • Support Annual Product Inspection (APR) and Coordination of the QA Reserve Sampling Room
  • Execution of QAIP walkthroughs
  • Comply with and ensure that all activities are performed according to Aveva’s facility and Department core SOPs and approved batch records.
  • Collaborate with Production Supervisor/Section Leader to resolve product quality issues.
  • Identifies quality concerns and escalates to management as appropriate
  • Initiation of Investigation as required.
  • Works as a member of a team to achieve all outcomes.
  • Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
  • Performs all work in support of company Values: Innovate, Evolve, and Excel 
  • Other duties assigned as assigned by the QA Management
  • Education
    • High School Diploma or equivalent, and or two-years of college; and two-four years related experience and/or training; or equivalent combination of education and experience.

     

knowledge, Skills and Abilities

  • Excellent written and verbal English communication skills.
  •  Experience with Microsoft Computer Products (Words, excel, Access, PowerPoint). Experience in JD Edwards ERP system is an asset
  • Superior interpersonal skills and ability to work effectively in a team environment within and outside the department
  • Ability to manage multiple priorities in a fast-paced environment
  • Attention to detail

Experience

  • Experience Working with cGMP procedures in a Pharmaceutical and or Combination Device manufacturing facility

Apply