Quality Supervisor - Filling (weekend PM)

Simtra BioPharma Solutions•Bloomington, IN

About The Position

The Quality Supervisor is a member of the Quality Assurance Leadership Team and reports directly to the Quality Manager. The role supports Quality Operations (QALO) and Manufacturing by supervising QALO personnel who provide quality oversight in manufacturing areas and helping ensure finished products meet required specifications. The supervisor provides decision-making and oversight to ensure compliance with regulatory agency requirements, guidelines, and Simtra Standard Operating Procedures. The role drives quality operations on the production floor and communicates with production team members, management, and cross-functional departments. It also fosters teamwork, productivity, safety, and quality in the finished product. The schedule is Friday evening through Monday morning, 1900–0700. Duties may require overtime, off-shift hours, and holidays as needed. The role requires appropriate PPE in manufacturing areas and the ability to gown-qualify for Grade C/D areas.

Requirements

Bachelor’s degree, preferably in a science discipline, and at least 2 years of Pharmaceutical Quality/Manufacturing or other GXP-regulated industry experience; or an Associate’s degree and at least 3 years of such experience; or no degree and at least 5 years of such experience.
At least 2 years of leadership experience.
Working knowledge of FDA CFR 210 and 211, other applicable regulations, and Good Documentation Practices (GDP).
Knowledge of aseptic manufacturing processes.
Good interpersonal, communication, influencing, and negotiation skills.
Proficiency with Microsoft Word, Excel, and Outlook, and ability to use enterprise software such as D365, Blue Mountain, or Veeva.
Strong technical, analytical, and problem-solving skills.
Ability to wear appropriate PPE in manufacturing areas and gown-qualify for Grade C/D areas.
Ability to use hands and fingers to manipulate office equipment.

Responsibilities

Perform all primary responsibilities of QALO personnel.
Grow, manage, develop, and empower QALO personnel, including hiring and performance evaluation.
Make timely, quality-focused decisions in collaboration with Manufacturing and cross-functional teams.
Ensure training and compliance for QALO associates and Quality Technicians.
Author and approve investigation and deviation reports.
Lead daily QALO activities and assist cross-functional areas with successful execution and implementation.
Ensure assigned tasks are completed by the supervisor and QALO personnel so quality and site metrics are met.
Author, revise, and review SOPs, batch records, and other documentation to meet corporate, plant, and regulatory requirements while supporting continuous improvement.
Ensure compliance with federal, state, local, and company-specific regulations related to product quality and employee safety.
Participate in and lead process and product improvement projects, focus groups, design of experiments, validations, methodology development or improvement, data generation, report development, and presentations.
Lead audit-readiness efforts for assigned areas and help other facility areas understand regulatory and Simtra quality requirements.
Maintain expertise in current regulatory requirements.