Quality Control Supervisor, 3rd Shift

INCOG BioPharma Services•Fishers, IN

7d•Onsite

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. Essential Job Functions: This position will support primarily third shift (11 pm to 7:30 am). 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. Special Job 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. Additional Preferences: 3-5 years demonstrated working knowledge of GMP laboratory operations. 1-2 years in a people leadership role. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

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