Quality Supervisor - Filling

Simtra BioPharma Solutions•Bloomington, IN

11d

About The Position

The Quality Supervisor is a member of the Quality Assurance Leadership Team and reports directly to the Quality Manager. The position supports Quality Operations (QALO) and Manufacturing by supervising QALO personnel who provide quality oversight in manufacturing areas, helping ensure finished products meet required specifications. The role provides decision-making and oversight to support compliance with regulatory requirements, guidelines, and Simtra Standard Operating Procedures. It supports quality operations on the production floor and communicates with production team members, management, and cross-functional departments. The supervisor fosters teamwork, productivity, safety, and the identity, strength, purity, and quality of finished products. The role includes managing and developing QALO personnel, making quality-first decisions with cross-functional teams, overseeing training and compliance, authoring and approving investigation and deviation reports, and leading daily QALO activities. It also includes maintaining documentation, supporting continuous improvement, ensuring regulatory and employee-safety compliance, leading improvement and validation work, supporting audit readiness, and maintaining expertise in current regulatory requirements.

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.
Computer proficiency in 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.
Must wear appropriate PPE for various manufacturing areas.
Must be able to 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 evaluating performance.
Make timely, quality-first decisions in collaboration with Manufacturing and other cross-functional teams.
Ensure training and compliance of 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 that 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, development or improvement of methodologies, data generation, report development, and presentations.
Lead audit-readiness efforts for assigned areas and assist other facility areas in understanding regulatory and Simtra quality requirements.
Maintain a high level of expertise in current regulatory requirements.