QA/QC Supervisor - Weekend PM

QA/QC Supervisor - Weekend PM

WHO?

Are you a quality professional with broad expertise across both Quality Assurance and Quality Control looking for an exciting opportunity where you can have an impact on global health and wellness?

We are looking for a Quality Supervisor who thrives at the intersection of QA and QC — someone who brings hands-on laboratory knowledge and a strong manufacturing floor presence to drive quality outcomes across the full product lifecycle. Are you a subject matter expert who enjoys learning and developing teams? Does the idea of building something new and impactful excite you? Join us in building a world-class CDMO for parenteral injectable drugs and shaping a new future for yourself, our clients, and patients.

This position is on the Weekend PM Shift (Friday, Saturday, Sunday) (7:00 PM to 7:30AM).

WHAT?

Working closely with the Director of Quality, the Quality Supervisor will serve as an integrated quality leader with accountability spanning both Quality Assurance Operations and Quality Control activities. This role is instrumental in championing INCOG’s Quality Mindset and fostering a culture of efficiency, attention to detail, and on-time delivery across manufacturing and laboratory functions.

The Supervisor will need to successfully navigate and identify operational and quality gaps in both the manufacturing environment and the QC laboratory setting. They will bring a balanced technical depth across GMP manufacturing oversight, contamination control, and laboratory testing operations — ensuring seamless alignment between QA and QC functions in support of compliant, inspection-ready operations.

The role responsibilities are as follows, but are not limited to:

Quality Assurance: Manufacturing Operations Support

• Recruit, build, and lead an integrated QA Operations team supporting aseptic drug product manufacturing.

• Responsible for training and maintaining an engaged workforce competent in both theory and application of Quality processes at a state-of-the-art aseptic drug product manufacturing facility.

• Lead through coaching, mentoring, and maintaining an on-the-floor presence in operations to ensure rigorous quality work standards and quality product manufacture.

• Prioritize and coordinate QA resources to balance production timelines with product quality assurances.

• Lead development of room/line clearance processes for formulation, aseptic filling, and inspection/packaging areas.

• Train QA team members on gowning requirements, area contamination controls, aseptic operational line processes, and equipment applications and verifications.

• Lead strategy and direction of the Quality Assurance team to partner with Operations in the performance of on-the-floor batch record review and correction.

• Establish an ongoing state of readiness in the exercising of rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions.

• Partner with EH&S and Operations management to communicate safety expectations, assess safety behaviors, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals.

Quality Control: Laboratory Operations Support

• Provide technical support, oversight, and team leadership for Quality Control Chemistry, Microbiology, and QC Technical Services activities.

• Oversee daily Quality Control activities, ensuring all testing and data review is completed within appropriate timeframes.

• Deliver daily expectations and assignments to QC personnel; provide in-lab support as needed for routine and on-demand testing.

• Assist in the development of individual QC team members by providing mentorship to analysts and data reviewers, and by communicating with Quality Control Leadership on team performance. • Support Quality Control deviation investigations, laboratory investigations, and CAPA implementation.

• Develop and improve current processes to maintain and control the general functions of INCOG Quality Control.

• Assure compliance with cGMP requirements in all QC laboratory operations.

• Perform laboratory walk-throughs and ensure laboratory spaces maintain inspection readiness and control.

Cross-Functional Quality Responsibilities

• Continuously evaluate internal processes and procedures across both QA and QC functions, working to create a productive environment while maintaining the highest possible quality standards.

• Influence the accomplishment of company-wide 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).

• Support deviation and CAPA management spanning both manufacturing and laboratory quality events.

YOU!

Ideally, candidates will have a Bachelor’s degree in a scientific discipline, along with 5 years of cGMP experience in Biopharma. Of that experience, a minimum of 3 years should come from Quality Assurance or Quality Control functions. It is preferrable that this candidate will also possess 2 years of experience as a people leader or supervisor.

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

Curious? Send us your resume at apply@leadcandidate.com or you can find more information on our website.

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.