Quality Assurance Specialist
1 month ago
Title: Quality Assurance Associate I
Contract: 1 Year
Location: Ridgefield, NJ - 07657
Shift: Mon- Fri | 8am – 4:30pm
Job Description
The Quality Assurance Inspector is responsible for ensuring the safety, efficacy, purity, and quality of manufactured products through compliance with relevant quality standards, regulations and established procedures. The Quality Assurance Inspector is part of the Quality Assurance Inspection (QAI) Department at Ridgefield, NJ.
Job Responsibilities
• Make sound decisions regarding packaging inspections, rework operations and final
disposition of incoming materials according to company policies and procedures with
minimum supervision.
• Strategically prioritize in-coming inspections to accommodate Manufacturing’s needs.
• Act as liaison with suppliers as necessary to resolve quality issues.
• Provide quality expertise and support to the Packaging and Manufacturing Operations
site (Quality Oversight, logbook/AQL Inspection Forms review, solve issues real time
with operations personnel, etc.) AQL – stands for Acceptable Quality Level
Three inspection levels are generally used: I, II, III. There are an additional four special levels — S1, S2, S3, S4 — that may be used where relatively small sample sizes are necessary, and also where larger sampling risks can be tolerated.
• Participate in process improvements to eliminate redundant inspections/ sampling.
• Well versed in ANSI.ASQ Z1.4 sampling plans (ANSI.ASQ Z1.4 is a Sampling Procedures and Tables for Inspection by Attributes. It is an acceptance sampling system used to inspect incoming, in-process, and final products to determine compliance with established acceptance criteria through the section of random samples of items. )
• Familiar with AQL sampling, normal, reduced, and tightened inspections and switching rules.
• Working knowledge of cGMP as it relates to inspection activities.
• Possess the ability to read and interpret component drawings and use measurement
tools such as calipers and micrometers.
• Possess the ability to evaluate certificate of analysis of chemicals/raw
materials/packaging components.
• Collaborate with Purchasing Department and Suppliers to resolve incoming inspection
paperwork discrepancies and shipping issues.
• Possess strong organization, communication, writing, people skills/teamwork and
detail oriented.
• Experience working in a team environment, facilitating a team approach, and
communicating effectively.
• Practice safe work habits and adhere to company safety procedures and guidelines
• Maintains compliance to company policies and procedures.
• Knowledge of medical device or drug packaging operations.
Education & Qualifications
- High School Diploma (or higher) with 1-3 years’ experience within a GMP environment.
- Experience with SAP ERP system, iLearn, QualiPSO and STARLIMS a plus.
- Knowledge in CGMP/regulatory compliance
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