Quality Supervisor - Filling

Simtra BioPharma Solutions•Bloomington, IN

13h

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. The supervisor helps ensure finished products meet required specifications and that activities comply with regulatory requirements, guidelines, and Simtra Standard Operating Procedures. The position drives quality operations on the production floor and communicates with production team members, management, and cross-functional departments. It develops and empowers QALO personnel, supports effective quality-first decision-making, and promotes teamwork, productivity, safety, and the identity, strength, purity, and quality of finished products.

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.
Wear appropriate PPE as required in various manufacturing areas.
Ability 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 performance evaluation.
Make timely, quality-first decisions in collaboration with Manufacturing and 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 for the supervisor and QALO personnel are completed and 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 concerning 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 expertise in current regulatory requirements.