Quality Assurance Associate I

Title: Quality Assurance Associate I
Location: Ridgefield, NJ
Duration: 12 Months+ Possible Extension

Pay Range: $40-$42/hr

Manager Notes:
Must Have:

• 1-3 years of QA experience, will accept more years of experience
• Knowledge in CGMP/regulatory compliance
• Incoming inspections, boxes inserts, vials, etc.
• Previous experience, performing visual inspections of filled products, locating particles, defects, functions defects.
• Must be familiar with caliper to measure components
• MS Office
• CAPAs, deviations, change controls
• Role is fully inside warehouse Requirement of chemical sampling
• Must be respirator certified (will be trained onsite)

 Nice to Have/ Preferred:
Experience with SAP ERP system, iLearn, QualiPSO and STARLIMS a plus.
• Experience with writing investigations

Description:
Must have flexibility in hours may be required to come in early or stay late depending on business needs (estimated twice a month). Also, occasional weekends, every few months.
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.

This role is responsible for performing incoming and in process inspection and be knowledgeable in the following:
• Make sound decisions regarding packaging inspections, rework operations and final
disposition of incoming materials according to Client policies and procedures with
minimum supervision.
• Perform audits, walk-throughs, GEMBAs, technical coaching
• Support Lead and Manager with tasks as needed (Change Control, Deviations etc)
• Must passed visual syringes/vials certification to perform manual visual AQL inspection of filled product.
• 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 Client safety procedures and guidelines
• Maintains compliance to Client policies and procedures.
• Knowledge of medical device or drug packaging operations.
• Flexible working schedule M-F, occasional late and early hours of operation including
weekends.

REQUIREMENTS
Education / Experience - 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
Must passed vision test