Quality Control Supervisor

Job Summary

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)

Contacts: APPLY TODAY and one of our recruiters will reach out to you shortly.

Referral Bonus: As always, we will give you a referral bonus if we place someone you refer over to us! Ask for details.