QC Planner

Quality Control Planner

INCOG Biopharma Services is seeking an individual to lead and oversee the QC planning activities at INCOG’s FDA-approved CDMO facility The QC Planner will play a crucial role within the QC laboratory, ensuring efficient planning and coordination of various QC activities.

This role is a great opportunity to lead and oversee the QC planning activities, working closely with the QC management team. The QC Planner will report directly to the QC Technical Services Manager, and will be a key player in allowing the QC department to run smoothly.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.

Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG’s clients.

Job Functions:

• Perform 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.
• Coordinate 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.
• Interpret and communicate special requirements to appropriate personnel.
• Update new plans and changes in the inventory management system.
• Develop and maintain sampling plans for incoming, production and stability samples.
• Ensure schedule stability by minimizing short term changes.
• Maintain 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.

Candidate Requirements:

• Associate or bachelor’s degree, preferred.
• 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.
• 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.).

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don’t meet all the requirements? Don’t sweat We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.