The QC Microbiology Supervisor is responsible for the following:
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
The QC Microbiology 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:
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.
Special Job Requirements:
This position will support primarily first shift (7 am to 4:30 pm).
Knowledge of Quality Control Microbiology, 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.
Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
By submitting your resume and details, you are declaring that the information is correct and accurate.
Skills Required
- Knowledge of Quality Control Microbiology
- Knowledge of GxP principles
- Experience with CAPA and investigation management
- Experience with data and document review
- Familiarity with relevant quality and regulatory requirements
- Knowledge of current Good Manufacturing Practices cGMP
- Strong communication and relationship-building skills
- Knowledge of aseptic techniques and processing
- 3-5 years of working knowledge of GMP laboratory operations
- 1-2 years of experience in a people leadership role
- Authorization to work full-time in the United States without sponsorship
What We Do
Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges. In addition, we will offer customized packaging services to include labeling, device assembly, final packaging and integrated storage solutions at various temperature conditions.
