Quality Control Supervisor, 3rd Shift

INCOG BioPharma ServicesFishers, IN
9dOnsite

About The Position

The Quality Control Supervisor is responsible for the following: Overseeing daily Quality Control 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 team The Quality Control Supervisor will be involved in Quality Control deviation investigations, laboratory investigations and CAPA implementation. They will also influence the accomplishments of companywide and team goals and objectives as well as inspire team members while consistently modeling ALP values in all interactions. This individual will ensure that all work is carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs) The Quality Control Supervisor will constantly evaluate the internal processes and procedures and work to create a productive space while maintaining the highest possible quality standards.

Requirements

  • Knowledge of Quality Control Microbiology and Chemistry, GxP principles, CAPA/Investigation management, and 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.

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 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 team
  • Involved in Quality Control deviation investigations, laboratory investigations and CAPA implementation
  • Influence the accomplishments of companywide and team goals and objectives
  • Inspire team members while consistently modeling ALP values in all interactions
  • Ensure that all work is carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs)
  • Constantly evaluate 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 Chemistry, Microbiology and Quality Control Technical Services
  • 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
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