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Quality Control Analyst II
Ref No.: 18-00170
Location: Cincinnati, Ohio
Position Type:Contract
Start Date: 02/06/2018
QUALITY CONTROL ANALYST II
CINCINNATI, OH

Project Description:
  • Ensure that equipment, solutions, and methods used in the Quality Control Laboratory meet all acceptance criteria and that lab notebooks and related documentation are accurate.
  • Perform routine and non-routine audit of chemical testing documentation for commercial, validation and stability samples in accordance to written methodology.
  • Familiarity of the qualitative and quantitative data that is typically generated using analytical instrumentation such as HPLC; GC, UV/Vis, KF and FTIR is a must.
  • Experience utilizing electronic laboratory information systems such as LIMS and Empower to perform the electronic review of analytical data.
  • Audit Analyst notebooks to ensure the following:
    • Test methods were correctly followed.
    • Verify data against approved specifications, notifying management of any OOS and aberrant results.
    • Ensure that the equipment used during an analysis was within the calibration date.
    • Verify the integrity and expiration date of solutions used to prepare samples COMPLIANCE AND QUALITY.
  • Basic knowledge and understanding of USP, cGMP, and FDA regulations.
  • Review lab record documentation (notebooks and computer based) according to GMPs.
  • Demonstrate the philosophy of Right First Time.
  • Maintain a clean and safe work environment and follow safety procedures and policies.
  • Provide feedback on systems and processes to promote continuous improvement and champion selected changes.
  • Grow in the job, accountable for establishing and accomplishing annual personal development goals.
  • Contribute to department and site goals.
  • Communicate clearly and well within a team environment.
  • Participate in daily direction setting huddles to provide feedback and ensure alignment on daily/weekly/monthly objectives.
  • Shares information with others – keeping management informed and helping department to meet the goals.
  • Actively participate in regular one-on-one meetings with direct supervisor.
  • Communicate external to the department, where applicable.
  • Collaborate effectively to achieve team and organizational goals.
  • Prioritize assigned work to maximize time and equipment efficiency.
  • Work independently with limited supervision for routine assignments.
  • Troubleshoot problems encountered with procedures, methods, and other processes - routinely solve, choosing among clearly defined alternatives.
  • Occasionally solve more complex problems - these may involve less familiar procedures or incomplete information.
  • Responsible for the accurate, timely and compliant execution of assigned projects, audit of analytical documentation.

Required Skills:
  • BS or higher in science related discipline, chemistry is preferred.
  • Minimum 3-5 years of experience in a pharmaceutical environment.
  • Auditing or peer review experience is mandatory.

This 9+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Jennifer: jennifer@alphaconsulting.com

ALPHA'S REQUIREMENT #18-00170
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE