Quality Assurance Lead - Finishing (3rd Shift)
Simtra BioPharma Solutions - Bloomington, IN
Hiring: Quality Assurance Lead - Finishing (3rd Shift) Company: Simtra BioPharma Solutions Location: Bloomington, IN Job Posted Time: 2026-09-11 13:51:40 Employment Type: Contract Target Skills & Keywords : Microsoft Excel, Quality Assurance About the job Experience: •2 years in a leadership role. Required Skills: •The working hours for this position are Monday-Friday 10:45p-6:45a •Demonstrated capacity to handle multiple projects and demonstrate effectiveness in team leadership, empowerment of others, task completion, decision-making and problem-solving, , deviation management. A functional understanding of FDA, Quality Systems, and GXP application is also required. •Must be able to become a Subject Matter Expert (SME) on applicable Quality procedures for Inspection and Packaging. Ensures department policy procedures align with Global and Regulatory standards. •Plans and schedules the work of QA Inspectors for required quality inspections and label control. •Interviews, hires, coaches, and develops staff. Provides guidance, support, direction and leadership through positive interactions with all personnel during daily operations. Conducts performance reviews for all direct reports, including setting performance objectives and development plans. •Achieves defined quality objectives aligned with site goals in an efficient, accurate, and timely manner. •Ensure business needs and timeliness requirements of the department are met or exceeded •Participate in or lead process/product improvement projects or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development, and presentation. Qualifications: •Minimum of 2 years in a leadership role. •Knowledge of inspection/labeling/packaging equipment and processes is preferred •Solid functional working knowledge of FDA Regulations, Application of Good Documentation Practices and Good Manufacturing Practices. •Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, ROBAR, etc.) •Must be able to perform physical tasks which include bending, twisting, kneeling and stooping. •Must be able to sit and stand for extended periods of time. •Must wear appropriate personal protective equipment, as applicable. •Duties may require overtime work, including nights, weekends, and Holidays. •Use of hands and fingers to manipulate office equipment is required. •In return, you’ll be eligible for [1] Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!