Quality Control Team Lead

Abbott•South Portland, ME
•Onsite

About The Position

The position of Quality Control Team Leader is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will perform work required to ensure Company product quality is maintained at standards set forth by Company Quality System and mandated by regulatory agencies such as the FDA, ISO, and USDA. The focus areas for a Quality Control Team Leader include but are not limited to: overseeing and coordinating the work of QC technicians; enforcing policies, procedures and work rules; manufacturing batch record review and approval. 2nd Shift: 2pm-10:30pm M-F

Requirements

  • Bachelor's degree in a Biology, Chemistry, Life Sciences, or other related technical fields, or equivalent combination of education and experience.
  • 3+ years’ laboratory/Quality Control experience

Nice To Haves

  • Prior Quality Control experience in medical device manufacturing
  • Knowledge of enzyme and/or immunochromatographic assays, generation of laboratory statistics, performance troubleshooting and data analysis.
  • Experience with GMP, FDA, ISO and USDA regulations

Responsibilities

  • Coordinates, facilitates and reviews in-process and final release testing for all products
  • Plans, assigns and directs the daily work activities in the Quality Control lab
  • Ensures effective transitions between shifts.
  • Works closely with individuals from other departments to ensure product is released on time and according to schedule
  • Works closely with Quality Control Manager to ensure all Quality Control objectives are met or exceeded
  • Enhances productivity by uncovering inefficiencies and recommending solutions
  • Trains new and current Quality Control technicians
  • Performs in-process and final release testing
  • Calibrate and maintain QC laboratory equipment according to schedule.
  • Initiates and authors Quality Incidents (QI)
  • Reviews/approves new and revised Standard Operating Procedures as necessary
  • Assists Manager in troubleshooting and other projects as necessary
  • Provides support for technical and quality issues
  • Communicates quality issues to QC management in a timely manner
  • The QC Team Leader is responsible for assisting QC Technicians by coaching, mentoring and training.
  • The Team Leader must perform all duties in a professional manner to ensure a positive team environment.

Benefits

  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with a high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
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