Quality Control Supervisor

  •  

Basking Ridge, NJ

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 32 days ago

  by    Faya Lou Bea

Job Summary

Title: Supervisor, Quality Control

Company: Biotech Company

Location: CA, MA, PA, NJ, NC

Type: Permanent Role

Notes: No Corp to Corp

Job Overview:

Reporting to the Senior Manager of Quality Control (Microbiology), the Quality Control Microbiology Supervisor – Environmental Monitoring will be responsible for leading Company's expanding environmental and critical utility monitoring program. The QC Microbiology Supervisor – Environmental Monitoring will play a critical role in implementing, maintaining, and improving Modern's environmental and critical utility monitoring program at Company's Norwood, MA manufacturing facility. This position may require off-shift hours including nights and weekend.

Responsibilities:

  • Effectively coordinate the execution of the environmental and critical utility monitoring program for the Norwood, MA manufacturing site.
  • Actively develop direct reports by seeking opportunities for cross training within and outside quality control
  • Collaborate effectively across all departments to meet key objectives
  • Conduct technical assessments of deviations and investigations
  • Conduct routine trend analysis of environmental monitoring data and prepare associated trend reports
  • Assist in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
  • Write/revise SOPs, technical protocols and reports
  • Work with the quality control management team to continuously improve the quality, compliance and efficiency of QC operations
  • Be proactive at keeping current with literature and latest technologies associated with contamination control principals
  • Effectively communicate internal issues related to performance, processes, and procedures
  • Establish and maintain a safe laboratory working environment
  • Accept, complete, and report on special assignments within the agreed upon timeframe
  • Act as designee for the Senior Manager of Quality Control (Microbiology) as appropriate

Requirements:

  • BS/BA and minimum 5-8 years or MS and 2-5 years in cGMP environment with a minimum of 2 years in a leadership role
  • Familiarity with relevant and current FDA, EU, ICH guidelines and regulations
  • Expertise in the use of MODA is preferred
  • Experience with risk management principals and their application to the development and execution of environmental monitoring and critical utility monitoring programs
  • Strong and effective people management skills
  • Strong knowledge of contamination control principals
  • Demonstrated knowledge of method development and qualifications
  • Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively
  • Outstanding communication skills (verbal and written)
  • Ability to manage multiple projects in a fast-paced environment
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment
  • Excellent communication skills (verbal and written)