INCOG BioPharma Services · 1 day ago
Quality Control Supervisor, 3rd Shift
Fishers, IN
Full-time
Onsite
Mid, Senior Level
3+ years expINCOG BioPharma Services is a world-class CDMO for parenteral injectable drugs, focused on building long-term value for customers. The Quality Control Supervisor is responsible for overseeing Quality Control activities, ensuring compliance with regulatory requirements, and providing leadership to the Quality Control team.
BiopharmaBiotechnologyManufacturingPharmaceutical
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)
Evaluate the internal processes and procedures and work to create a productive space while maintaining the highest possible quality standards
Provide technical support, oversight 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
Qualification
Required
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
Support primarily third shift (11 pm to 7:30 am)
Provide technical support, oversight 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
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
Preferred
3-5 years demonstrated working knowledge of GMP laboratory operations
1-2 years in a people leadership role
Company
INCOG BioPharma Services
Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$86.63M2024-05-29Series B· $42.86M
2022-05-10Undisclosed· $15M
2022-05-10Debt Financing
Leadership Team
Tedd Green
Co-founder & Chief Operating Officer
Recent News
Inside INdiana Business
2025-12-16
Company data provided by crunchbase