Quality Control Specialist

2 weeks ago


Ridgefield, New Jersey, United States Randstad Life Sciences US Full time

Position: Quality Assurance Specialist

Contract Duration: 1 Year

Job Overview

The Quality Assurance Specialist plays a crucial role in guaranteeing the safety, effectiveness, purity, and overall quality of products manufactured by adhering to applicable quality standards, regulations, and established protocols. This position is part of the Quality Assurance Inspection (QAI) Department.

Key Responsibilities

  • Make informed decisions regarding packaging evaluations, rework processes, and the final assessment of incoming materials in accordance with company policies with minimal oversight.
  • Effectively prioritize incoming inspections to meet the needs of manufacturing operations.
  • Serve as a point of contact with suppliers to address and resolve quality-related concerns.
  • Provide quality assurance expertise and support to the Packaging and Manufacturing Operations, including oversight, logbook reviews, and real-time issue resolution with operational staff.
  • Engage in process enhancements to eliminate unnecessary inspections and sampling.
  • Demonstrate proficiency in ANSI.ASQ Z1.4 sampling plans, which are used for inspecting incoming, in-process, and final products to ensure compliance with established criteria.
  • Familiarity with AQL sampling methods, including normal, reduced, and tightened inspections, as well as switching rules.
  • Possess a solid understanding of cGMP as it pertains to inspection activities.
  • Ability to read and interpret component drawings and utilize measurement instruments such as calipers and micrometers.
  • Evaluate certificates of analysis for chemicals, raw materials, and packaging components.
  • Collaborate with the Purchasing Department and suppliers to resolve discrepancies in incoming inspection documentation and shipping issues.
  • Exhibit strong organizational, communication, writing, and teamwork skills, with a keen attention to detail.
  • Experience in a collaborative team environment, promoting teamwork and effective communication.
  • Adhere to safe work practices and comply with company safety protocols.
  • Maintain compliance with company policies and procedures.
  • Possess knowledge of medical device or pharmaceutical packaging operations.

Education & Qualifications

  • High School Diploma or higher with 1-3 years of experience in a GMP environment.
  • Familiarity with SAP ERP systems, iLearn, QualiPSO, and STARLIMS is advantageous.
  • Understanding of CGMP and regulatory compliance standards.


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