QA Inspector

Renaissance Lakewood LLC; Lakewood Township (NJ); On-site; USD 53,000 - 58,000; Full time

Job summary

Renaissance Lakewood LLC seeks a Quality Assurance Technician in New Jersey to perform QA tasks, inspections, and sampling on packaging lines and compounding suites. The role emphasizes GMP compliance, documentation accuracy, and cleanroom procedures.

The successful candidate will gown to Grade C standards, review batch records, and ensure compliance with SOPs. This on-site position offers growth within a regulated manufacturing environment and requires a HS diploma or GED with 3+ years of

Qualifications

• QA tasks including line clearances, sampling, inspections, and testing of quality attributes.
• Monitor product quality via required visual testing.

Responsibilities

• Perform QA tasks including line clearances, sampling, inspections, and quality attributes testing.
• Monitor product quality through required visual testing.
• Perform routine line clearances and in-process inspections on packaging lines and compounding suites.
• Ensure day-to-day activities in compounding/packaging comply with SOPs and GMP.
• Monitor packaging/compounding to ensure batch docs and SOPs are followed.
• Review paperwork for accuracy and GMP compliance.
• Gown to Grade C standards and inspect within cleanrooms.
• Report non-conformances related to components, in-process materials, or finished products.
• Collect samples for testing and ensure timely submission to the laboratory.
• Inspect and approve packaging components and equipment prior to use.
• Sample in-process items and finished products; perform inspections and testing.
• Apply disposition stickers to components and finished products.
• Stage labels and inserts on production lines; verify part numbers.
• Distribute samples to QA Laboratory for evaluation.
• Review records for accuracy and GMP compliance.
• Document all work in batch records, forms, and logs.
• Provide training to QA and Operations staff on procedures.
• Maintain a clean, safe environment per regulations.
• Operate computer-based systems and equipment.
• Perform other duties as assigned.

Skills

Quality Assurance

GMP Compliance

Documentation

Inspections

Cleanroom

Education

High School diploma or GED

Tools

Computer systems

Job description

• Pay or shift range: $53,300 USD to $57,900 USD
  The estimated range is the budgeted amount for this position. Final offers are based on various factors, including skill set, experience, location, qualifications and other job-related reasons.

Description

• Perform Quality Assurance tasks including production line clearances, sampling, inspections, and quality attributes testing designed
• Monitor product quality through the performance of required visual testing A brief description of the job's primary purpose or contribution to the department or organization.
• Perform routine line clearances/in-process inspections on the packaging lines and compounding suites.
• Ensure routine compliance of day to day activities on the compounding and packaging areas; working with operations personnel to achieve compliance.
• Monitor packaging and compounding to ensure that batch documentation requirements and SOPs are being followed.
• Review the required paperwork for accuracy and compliance, both on line and upon completion of the activity.
• Ability to gown to Grade C standards and perform quality inspection inside cleanroom areas.
• Report non-conformances associated with components, in-process materials, finished products, etc. that may be identified at any stage of production or storage.
• Collect representative samples for testing and retention, and ensure all relevant paperwork is complete. Submit samples/resamples to laboratory in a timely fashion to meet production needs.
• Inspect and approve packaging components, manufacturing/packaging rooms, lines and equipment prior to use.
• Sample in-process items and finished products. Perform required inspections and testing of in-process items and finished products.
• Apply disposition stickers to components, in-process materials and finished products.
• Stage label and inserts on production lines, issuing reports and verifying customer and Renaissance part numbers and comparing information to the staging sheet. Return unused labels and inserts or have them destroyed when requested by customer.
• Process and distribute samples to other teams (i.e. Quality Control Laboratory) for evaluation and testing, as required.
• Review records to confirm accuracy, completeness and GMP compliance.
• Ensure all work performed is documented accurately and completely in batch records, forms, logs and other documents.
• Provide training to QA and Operations staff on proper documentation and inspection procedures.
• Maintain a clean and safe environment in compliance with State and Federal regulatory guidelines.
• Ability to work with computer based systems and equipment.
• Perform other duties and responsibilities as assigned.

Required

High School diploma or GED and a minimum of 3 years of relevant experience or equivalent combination of education and experience.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.