QA Inspector, 1st shift

Company: Renaissance Pharmaceuticals
Location: Lakewood
Posted on: January 1, 2020

Job Description:

Overview

Quality Assurance Inspectors work "hands-on" on the production floor, inspecting packaging, labeling and finished products to ensure products comply with Company policies and standard operating procedures (SOPs) and Good Manufacturing Practices (GMP) requirements. Quality Assurance Inspectors perform sampling, inspection and physical testing of packaging components and raw materials. They issue and control the labels and packaging inserts and are responsible for following all quality assurance procedures and ensuring all documentation meets cGMP standards.

Responsibilities

--- 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.
--- 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.

Qualifications

High School diploma or GED and a minimum of 3 years of relevant experience or equivalent combination of education and experience. PI116686164

Keywords: Renaissance Pharmaceuticals, Lakewood , QA Inspector, 1st shift, Other , Lakewood, New Jersey