QA Supervisor - IDAP 2nd Shift

INCOG BioPharma Services • Fishers, IN

10d • Onsite

About The Position

Working closely with the Manager of Quality, the Quality Assurance Supervisor - IDAP will be instrumental in championing and developing our organization’s Quality Mindset and a culture of efficiency, attention to detail, and delivery on time. The Supervisor will need to successfully navigate and identify operational and quality gaps. The Quality Assurance Supervisor will exemplify excellent interpersonal skills and develop productive, customer-centric working relationships with subordinates and colleagues, customers, suppliers, and partners. The Supervisor will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The Supervisor will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The supervisor will value process owners and subject matter experts and will possess a demonstrated ability to influence positive outcomes without direct reporting authority.

Requirements

• Bachelor’s degree in a science, engineering, or related discipline is preferred but not required; equivalent combination of education and relevant experience will be considered
• Minimum of 5 years of cGMP experience in biopharma or similarly regulated industry.
• Minimum of 2 years of Quality Assurance experience in biopharma or similarly regulated industry.
• Intermediate level of understanding and oversight of contamination controls, manufacturing processes, and output quality using automated and non-automated manufacturing systems with associated data integrity requirements.  Prior experience and comfort with making risk-based decisions to ensure product quality required.

Nice To Haves

• Hands-on experience with visual manual inspection, device assembly and/or packaging Quality.
• 2+ years of experience as a people leader or supervisor.
• First-hand experience participating in and/or hosting operation floor inspection tours related to Quality Assurance.
• Experience with building processes and procedures.
• Familiarity with sterile injectable drug product manufacturing, including aseptic fill-finish operations
• Experience with electronic QMS platforms (e.g., TrackWise, Veeva, MasterControl) and document management systems
• Prior experience at a CDMO or contract manufacturing environment supporting multiple clients and product configurations

Responsibilities

• Recruit, build, and lead a QA Operations team, specifically focused on Inspection, Device Assembly and Packaging operations.
• Responsible for training and maintaining an engaged work force competent in both theory and application of Quality processes.
• 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 and needs.
• Lead and support development of processes for inspection, device assembly and packaging operations.
• Lead strategy and direction of the Quality Assurance team to partner with Operations in the performance of on-the-floor batch record review and corrections.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager