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QC Chemist II / Microbiologist II
Ref No.: 17-01601
Location: Norwich, New York
Position Type:Contract
Start Date: 11/16/2017

Project Description:
  • Performs routine and complex sample analysis requiring refined laboratory skills, technical expertise, and astute observation to assess the conformance of raw materials, finished products, and/or stability samples to predetermined product specifications.
  • Performs testing with expertise and understanding of scientific principles in conformance with approved procedures, accurately and concisely documents data, and reports results.
  • Demonstrates an advanced knowledge of SOP's and GMP regulations as related to the pharmaceutical quality control laboratory.
  • The Quality Control Chemist II / Microbiologist II reports into the Manager Quality Control or Team Leader Quality Control.

  • Perform job functions in a safe manner consistent with site safe practices and regulatory (e.g. – OSHA) requirements.
  • Participate in weekly/monthly safety training, identify potential safety hazards and cooperate with investigations of safety related incidents
  • Conduct assigned tasks in compliance with cGXP requirements, current industry standards, compendia standards, FDA expectations and internal procedures.
  • Assist with laboratory investigations to ensure they are conducted in a timely manner and are completed within established target completion dates.
  • Ensure they have been appropriately trained before performing a GMP task.
  • Schedule and/or perform necessary validation, qualification and calibration of laboratory equipment/instruments as needed.
  • Perform routine and complex sample analysis requiring refined laboratory skills and technical expertise such as HPLC, GC, Dissolution, USP/EP raw material testing, wet chemistry, spectrophotometric techniques, or microbiological techniques.
  • Comprehend scientific principles and follow approved test methods accurately in the performance of sample analysis to ensure adherence to "Right-the-First Time” philosophy.
  • Applies theoretical knowledge, education, experience, and training in conjunction with technical resources to troubleshoot and resolve problems.
  • Use advanced software functions to control instrumentation, collect data, process and calculate results, and report results.
  • Uses available resources to effect system improvement or development of laboratory systems.
  • Communicate with clients, contractors, and regulatory agents as required.
  • Provide leadership and guidance to junior staff and coordination of work efforts for junior staff in relation to project work assigned.
  • Work independently and seek supervision when required.
  • Calculate results and interpret data in relation to project objectives and historical data.
  • Notify manager immediately of nonconforming data or unexpected occurrences and proactively participates in resulting investigation.
  • Organize work schedule and coordinates with other analysts to complete assigned tasks efficiently and on schedule.
  • Train other QC staff on SAP QM, lab techniques and instrumentation/equipment using SOPs, QATs, HOCs and other approved documents.
  • Update various GMP documents including but not limited to SOPs, QATs, HOCs, change controls, safe practices, protocols, templates and reports demonstrating strong technical writing skills.
  • Perform specialized maintenance and calibration of laboratory equipment (Metrology) as needed.
  • Perform required daily maintenance and/or calibration of laboratory equipment/instruments consistent with established SOPs/QATs as needed.
  • Familiar with department and plant systems and effectively operate within systems to achieve desired results.
  • Witness analytical notebooks of peers.
  • Other duties as assigned.

Required Skills:
  • MS degree in Chemistry, Biochemistry, Biology or Microbiology or related discipline.
  • At least 2 years' experience in a pharmaceutical or related environment.
  • Understanding of cGXP requirements preferred.
  • Strong organization, communication and interpersonal skills.
  • Oral and written communication skills including technical writing.
  • Responsible for decisions related to:
    • When laboratory management must be notified to determine whether an investigation is warranted.
    • Whether they have been trained to perform a GMP task.
    • Suitability of analytical equipment/instruments for use.
    • When a Change Control is warranted.
    • When a QC staff member has satisfied training requirements for a given task.

This + month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Patrick: