QC Microbiology Supervisor

INCOG BioPharma ServicesFishers, IN
Onsite

About The Position

The QC Microbiology Supervisor is responsible for overseeing daily Quality Control Microbiology activities, ensuring all testing and data review are completed within appropriate timeframes, and delivering daily expectations and assignments. This role provides in-lab support and oversight of routine/on-demand testing, along with coaching and feedback to the Quality Control microbiology team. The supervisor will be involved in Quality Control deviation investigations, laboratory investigations, and CAPA implementation. They will influence companywide and team goals, inspire team members, and consistently model ALP values. This individual ensures all work adheres to regulatory requirements, Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs). The Quality Control Supervisor continuously evaluates internal processes and procedures to create a productive space while maintaining the highest quality standards.

Requirements

  • Knowledge of Quality Control Microbiology
  • Knowledge of GxP principles
  • Knowledge of CAPA/Investigation management
  • Knowledge of data/document review
  • Familiarity with relevant quality and regulatory requirements and trends and cGMP's
  • Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including business managers, operations leaders, and technical leaders
  • Knowledge of Aseptic techniques and processing
  • Qualified applicants must be authorized to work in the United States on a full-time basis.

Nice To Haves

  • 3-5 years demonstrated working knowledge of GMP laboratory operations
  • 1-2 years in a people leadership role

Responsibilities

  • Overseeing daily Quality Control Microbiology activities
  • Ensuring all testing/data review is completed within appropriate timeframes
  • Delivering daily expectations and assignments
  • Providing in-lab support, as needed, and oversight of routine/on-demand testing
  • Providing coaching and feedback to Quality Control microbiology team
  • Involvement in Quality Control deviation investigations, laboratory investigations and CAPA implementation
  • Influencing the accomplishments of companywide and team goals and objectives
  • Inspiring team members while consistently modeling ALP values
  • Ensuring that all work is carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs)
  • Constantly evaluating the internal processes and procedures and work to create a productive space while maintaining the highest possible quality standards
  • Provide technical support, oversite and team leadership for Quality Control Microbiology
  • Assist in the development of individual team members by providing mentorship to analysts/data reviewers and communicating with Quality Control Leadership on team performance
  • Develop and improve current processes to maintain and control the general functions of INCOG Quality Control
  • Assure compliance with cGMP requirements (current good manufacturing practices)
  • Perform laboratory walk-throughs and ensure laboratory spaces maintain inspection readiness and control

Benefits

  • Equal Opportunity Employer
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