Quality Control Senior Specialist

  • Contract Duration: 6 months with potential to extend
  • Manufacturing
  • Boston, MA

Website Lenox Executive Search

Description

Lenox Executive Search is seeking a Quality Control, Senior Specialist, for a 12 month contract position with one of our global pharmaceutical companies, working onsite in Boston, MA.

KEY RESPONSIBILITIES of aQuality Control, Senior Specialist:

  • Collect, transport and process environmental monitoring of air, surface, personnel gowning, water, gas and steam systems samples according to established schedules or as requested with minimal supervision.
  • Perform microbiological (Bioburden) and chemical assays (Endotoxin, Total Organic Carbon, Conductivity, and Nitrates), related to clean room monitoring, utility monitoring independently following established methodology, procedures, and SOPs.
  • Analyze organisms on cultured media from environmental monitoring and utility samples
  • Maintain accurate sampling and testing records and adhere to cGMP/GDP expectations
  • Report OOT/OOS results and other deviations to area management.
  • Review independently following established methodology, procedures, and SOPs
  • Assist in troubleshooting of analytical microbiological and chemical methods with the assistance of supervisor when necessary
  • Participate in executing method validations and/or classified areas qualifications.
  • May participates in author and review data, procedures, microbiological and chemical analytical methods, protocols, reports, deviations, and other quality records.
  • May participate in compliance related teams working towards the goal of continuous improvement.
  • May perform maintenance of instrument/ equipment calibration, temperature monitoring, reagent preparation, material and supply ordering and other general lab related responsibilities, as needed.
  • Assists in everyday organization of the EM/UM laboratory including safety, cleaning, maintenance and ordering of supplies.
  • May provide environmental monitoring and utilities monitoring guidance for training to junior staff or other departments.
  • Perform other laboratory duties as assigned.

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REQUIRED EDUCATION LEVEL of aQuality Control, Senior Specialist:

  • A minimum of a bachelor’s degree in science (i.e., microbiology or related discipline) is required.

REQUIRED EXPERIENCE of aQuality Control, Senior Specialist:

  • 6+ years of experience in pharmaceutical / biopharmaceutical industry/ or laboratory setting (microbiology and environmental monitoring preferred). And 2 years in the lab

REQUIRED KNOWLEDGE/SKILLS of aQuality Control, Senior Specialist:

  • Understand cGMP concepts and general practices.
  • Knowledge and experience in microbiology methods and/or aseptic techniques and sample collection.
  • Knowledge of various laboratory equipment including Microbial ID systems, Chemical Analysis, pH meter, and balance. etc.
  • The ability to work well on a team in a fast-paced environment, manage priorities and maintain timelines for multiple projects is essential.
  • Strong attention to detail, proactive, action oriented and can rapidly adapt to a change
  • Demonstrate good communication skills, both verbal and written, at all levels and across various functions.
  • Experience using Laboratory Information Management System (LIMS) and Electronic Laboratory Notebooks (ELN) to document and report results
  • Ability to work weekends and off-shift hours, as needed.
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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