QC Planner
Description
The Quality Control Planner will play a crucial role at INCOG within the QC laboratory, ensuring the efficient planning and coordination of various Quality Control activities. While other duties may be assigned, the general overview of the responsibilities and qualifications for this role at INCOG include:
Performs analysis to determine optimal testing schedule for QC laboratories with a combination of key inputs, including Customer requirements from the Project Management personnel, production sequencing personnel and equipment availability.
- Coordinates sample management for QC laboratories.
- Collaborate with cross-functional teams to develop and implement QC sampling and testing strategies.
- Develop and maintain reference standard, reagent and consumable inventory levels to prevent stockouts or overstock situation for the QC laboratories. Implement inventory control measures and optimize stock rotation.
- Interprets and communicates special requirements to appropriate personnel.
- Updates new plans and changes in the inventory management system.
- Develop and maintain sampling plans for incoming, production and stability samples.
- Ensures schedule stability by minimizing short term changes.
- Maintains equipment calibration and maintenance schedules.
- Responsible for updating existing reports and developing new ones.
- Responsible for tracking departmental performance metrics, as required.
- Work closely with all internal and external suppliers and vendors.
- Maintain work area to 6S standards as posted in work area.
- Maintain SOPs (Standard Operating Procedure) for all duties and tasks.
Required experience or skills:
- Minimum of 3 years of biopharma industry experience, of which at least 2 years have been in a role of hands-on experience with Quality Control in a regulated environment.
- Associate or bachelor’s degree, preferred.
- Project management and awareness of scheduling tools.
- First-hand experience participating in and/or hosting audits/inspections related to Quality Control.
- Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, SharePoint, PowerBI etc.).
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.
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.