Quality Control Supervisor, 3rd Shift

INCOG BioPharma Services•Fishers, IN

1d•Onsite

About The Position

The Quality Control Supervisor is responsible for overseeing daily Quality Control activities, ensuring all testing/data review is completed within appropriate timeframes, and delivering daily expectations and assignments. This role provides in-lab support, as needed, and oversight of routine/on-demand testing, along with coaching and feedback to the Quality Control team. The 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, and inspire team members while consistently modeling ALP values in all interactions. This individual ensures all work is carried out in accordance with regulatory requirements, Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs). The Quality Control Supervisor constantly evaluates internal processes and procedures to create a productive space while maintaining the highest possible quality standards. Essential job functions include providing technical support, oversight, and team leadership for Quality Control Chemistry, Microbiology, and Quality Control Technical Services. The supervisor assists in the development of individual team members by providing mentorship to analysts/data reviewers and communicating with Quality Control Leadership on team performance. They also develop and improve current processes to maintain and control the general functions of INCOG Quality Control, assure compliance with cGMP requirements, perform laboratory walk-throughs, and ensure laboratory spaces maintain inspection readiness and control.

Requirements

Knowledge of Quality Control Microbiology and Chemistry
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
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