Manager, Quality Control

Job Locations US-MA-Bedford
Posted Date 3 weeks ago(2/1/2018 8:49 AM)
Job ID
2018-1045
# of Openings
1
Category
Quality

Overview

The Quality Control Manager maintains quality standards for our pharmaceutical products by supervising and managing incoming materials, including inspections and physical testing of in-process and finished drug products.  This individual will manage inspection and physical testing results, in addition, manage and supervise the activities of Quality Control Inspectors. 

Responsibilities

  •  Provide leadership in the QC organization to ensure compliance, drive improvements, achieve schedule adherence.
  • Work with cross-functional teams to align testing schedules to meet production needs. Interact with receiving and manufacturing departments to ensure inspections are completed in a timely manner.
  •  Generate and manage timelines based on the production schedule and forecasting supply requirements to ensure there are no delays in disposition of final product.
  •  Communicate inspection and testing issues to supervisor.
  •  Supervise physical testing of in-process, final drug products and incoming raw materials. Conduct testing when additional support is needed.
  •  Collect, track and report metrics to manager and improve laboratory performance. Improve and maintain the overall appearance and functionality of the laboratory.
  •  Collaborate with Metrology to maintain equipment in working order.
  •  Identify, initiate, implement and follow up continuous improvement projects.
  •   Author and revise SOPs as needed/required, including material trending, tracking and material flow processes.
  •  Supervise and manage applicable deviations and investigations. Conduct Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations.
  •  Lead and suggest improvements to existing inspection methods.
  •  Perform additional quality control duties as assigned.

Qualifications

  • Bachelor’s Degree in Life Sciences; Chemistry or Biology preferred
  • 5+ years’ related experience in pharmaceutical industry, with prior supervisory experience.
  •  Operation in a GMP setting to include use of Good Documentation practices.
  • Ability to lift up to 25 pounds, perform visual inspections and physical testing (dimensional analysis, gel time, etc.).
  • Proficient with quality measuring instruments such as calipers, pipettes, balances, microscopes, and Instron
  • Experience working in clean room is a plus
  • Knowledge of safe laboratory practices
  • Knowledge of CFR 210, 211, USP, and FDA/ICH guidance
  • Excellent organizational skills and attention to detail
  • Strong verbal and written communication skills
  • Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.

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