Chemistry Quality Control Manager

1 day ago

Winnipeg, Manitoba, Canada Emergent Biosolutions Full time

At Emergent BioSolutions, we seek a talented and experienced individual to fill the role of Supervisor, Quality Control Chemistry. This position is responsible for the successful execution of key quality responsibilities and assigned tasks within the Quality Control area.



Key Responsibilities:

  • Plan, schedule, allocate, and prioritize workload to meet operating requirements in the assigned Quality Control area.
  • Lead laboratory investigations and provide oversight to the content of investigation reports.
  • Use analytical data and/or statistical concepts to understand variables impacting assay and process performance. Investigate aberrant trends and assist with troubleshooting of test procedures.
  • Ensure adherence to quality standards and compliance with the requirements of current Good Manufacturing Practices (cGMP).
  • Apply expertise to support change and risk management, including application of scientific and technical innovation.
  • Initiate or coordinate the preparation of reports and maintenance of records pertaining to the operation of the work unit in a manner suitable for regulatory submission or inspection.
  • Coordinate/lead cross-functional teams in process mapping and other exercises designed to facilitate process and system understanding.
  • Coaches employees through problems of diverse scope in which analysis of situations or data requires evaluation of identifiable factors.
  • Direct subordinates to complete assignments using established guidelines, procedures, and policies.
  • Provide development opportunities to staff through training, development plans, participation in appropriately challenging activities, and applying leadership architect concepts.
  • Work in collaboration with direct manager, subordinates, internal customers, and other cross-functional peers to gain alignment on sound quality decisions.
  • Support workforce diversity, safety, and adherence to company core values.


Requirements:

  • Minimum of 5 years of relevant experience, accompanied by a bachelor's degree in science, or an equivalent combination of education and experience.
  • Requires a broad scope of technical knowledge to assist with modeling or design, complex troubleshooting, draft method validation protocols, and/or investigate complex deviations.
  • Excellent written and verbal communication skills.
  • Thorough knowledge of GMP and WHMIS and biohazard safety awareness.
  • Scientific knowledge of standard practices in the area of assignment.
  • Knowledge of supervisory practices and techniques.
  • Ability to conduct investigative interviews.


Physical and Mental Demands:

  • Ability to organize/coordinate.
  • Comprehend and follow instructions.
  • Direct, control, and plan.
  • Independently make quick decisions to solve complex issues.
  • Problem solve.
  • Analyze/interpret data and information.
  • Perform with frequent interruptions.
  • Make decisions using sound judgment.
  • Supervise/manage others.


Environmental Characteristics:

  • Regular and predictable attendance.
  • Work around extreme temperatures – cold or hot.
  • Work around noise above conversation level.
  • Work in restricted access to laboratory area.
  • Exposure to dust/gas/fumes/steam/chemicals.
  • Work with Select Agents as defined by the CDC.
  • Work irregular hours that often include nights and weekends.
  • Work in multiple locations.

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