Quality Assurance Specialist (v227)

  • Contract Duration: 6-8 months to start, Hybrid Onsite
  • Clinical
  • Boston, MA

Website Lenox Executive Search

Description

Lenox Executive Search is looking to fill a current opening for a Quality Assurance Specialist, with one of our global pharmaceutical clients. This is a contract position that has the potential to become permanent based on performance.

Key Duties and Responsibilities of a Quality Assurance Specialist:

  • Performs analytical data review for commercial release and stability and verify documentation and determines acceptability by using standard operating procedures.
  • Perform quality review/ approve of raw data and COAs in support of commercial batch release when needed.
  • Upload the vendor created protocols in electronic document management system and update all commercial stability-controlled documents including Vendors Stability Protocols, Initiation Forms, and Data Tables. In addition, update JMP files for all commercial products if needed.
  • Provide support to Clinical analytical data review as needed
  • Support the day-to-day management of the analytical data from external CMO – Update trackers in a timely manner upon receipt of data from external vendors and follow up for any major delays or issues.
  • Communicates proactively with internal and external partners and management.
  • Assists department management with monthly/quarterly Quality System data review metrics and reporting
  • Escalate critical and major finding to Quality management related to GXP Operational areas.

Knowledge and Skills of a Quality Assurance Specialist:

  • Strong communication and influencing skills
  • Ability to evaluate quality matters and make decisions utilizing risk-based approach
  • Proficiency in using Microsoft Office applications
  • Some experience with quality metrics, dashboards, analysis, and improvement programs
  • Some experience with network-based applications such as Oracle, Veeva, etc
  • Basic knowledge of current industry trends and regulatory requirements

Education and Experience of a Quality Assurance Specialist:

  • Bachelor’s degree in relevant field is required
  • Typically requires 2 years of experience or the equivalent combination of education and experience
Upload your resume here.

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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