Quality Supervisor - Filling (2nd shift)

Simtra BioPharma Solutions•Bloomington, IN

10d

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, helping ensure finished products meet required specifications. The supervisor supports and drives quality operations on the production floor and communicates with production team members, management, and cross-functional departments. The position promotes teamwork, productivity, safety, and the identity, strength, purity, and quality of finished products. The schedule is Monday through Thursday, 1400–0030. Duties may require overtime, off-shift hours, and holidays as needed. The role requires appropriate personal protective equipment in manufacturing areas and qualification to gown for Grade C/D areas.

Requirements

Bachelor’s degree, preferably in a science discipline, plus at least 2 years of Pharmaceutical Quality/Manufacturing or other GXP-regulated industry experience; or an associate degree plus at least 3 years of such experience; or no degree plus 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.
Strong interpersonal, communication, influencing, and negotiation skills.
Computer proficiency in Microsoft Word, Excel, and Outlook, and ability to use enterprise software.
Strong technical, analytical, and problem-solving skills.
Ability to wear required PPE in manufacturing areas and qualify for gowning in Grade C/D areas.
Ability to work overtime, including off-shift hours and holidays, as required.
Ability to use hands and fingers to manipulate office equipment.

Nice To Haves

Experience with enterprise software such as D365, Blue Mountain, or Veeva.

Responsibilities

Successfully perform all primary responsibilities of QALO personnel.
Grow, manage, develop, and empower QALO personnel, including hiring and performance evaluations.
Make timely, quality-first 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 applicable federal, state, local, and company 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 help other facility areas understand regulatory and Simtra quality requirements.
Maintain expertise in current regulatory requirements.