Quality Assurance Associate I, GMP (s013)

  • Contract Duration: 12+ months
  • Miscellaneous
  • Ridgefield, NJ

Website Lenox Executive Search

Lenox Executive Search is seeking a Quality Assurance Associate I, to fill a 12+ month onsite contractual role, with a leading global pharmaceutical company in Ridgefield, NJ.

Note: Position requires full Covid vaccination.

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. 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 internal 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.)
• Participate in process improvements to eliminate redundant inspections/ sampling.
• Well versed in ANSI.ASQ Z1.4 sampling plans
• 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 all safety procedures and guidelines
• Maintains compliance to company policies and procedures.
• Knowledge of medical device or drug packaging operations.
• Flexible working schedule M-F, occasional late and early ours of operation including weekends.
• High School Diploma (or higher) with 1-3 years experience within a GMP environment.
• Experience with SAP ERP system, GEODE+, iLearn, Phenix and STARLIMS a plus.
• Knowledge in CGMP/regulatory compliance

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Our COVID-19 Policy

As with other larger employers and customer-facing organizations, Lenox Executive Search is carefully monitoring the situation regarding Coronavirus (COVID-19), with a particular focus on public health guidance offered by the CDC and state officials.  We are reaching out to make you aware of our activities and preparations in light of the spread of the Coronavirus (COVID-19). Our number one priority is the safety of our employees, clients and the broader community. Given the current unpredictable nature of the spread of COVID-19, and in an abundance of caution, Lenox Executive Search has implemented the following practices immediately:
  • We have increased our overnight cleaning activities to ensure frequently touched areas are being disinfected and sanitized.
  • We have implemented social distancing techniques to minimize the typical face-to-face- contact by utilizing teleconference calls and flexible workspaces.  We have suspended non-essential business travel for our employees and have asked that inter-company meetings be conducted via teleconference. In addition, we kindly ask all of our customers to help us maintain a handshake-free zone at all Lenox Executive Search locations.
  • We have asked employers who feel ill to stay home.
  • We have convened a team of senior leaders who meet daily to discuss the situation and stand ready to take additional steps, if necessary.
  • We have measures in place to ensure our operations can effectively continue so that we can provide our clients uninterrupted service.  Lenox Executive Search already had robust and detailed business continuity plans in place.
– The Lenox Executive Search Team