Supervisor, Manufacturing Operations (Compounding) 3rd Shift

Quva•Sugar Land, TX

1d•Onsite

About The Position

The Supervisor, Manufacturing Operations (Compounding) coordinates the daily work schedules of people and equipment in Compounding Operations after completing training. The role ensures pharmaceutical products are made in accordance with safety, quality, and delivery standards and that operators follow validated parameters, standard operating procedures, cGMP regulations, and safety requirements. The position supervises, trains, and develops technicians; reviews production documentation; completes in-process checks; resolves operational issues; and advances continuous improvement and Quality Management System assignments. This is a full-time, on-site role at the Sugar Land, Texas location, working a set third-shift schedule Monday through Friday from 10:00 PM to 6:30 AM. It is safety sensitive and may be subject to random drug testing in accordance with applicable laws.

Requirements

High school diploma or GED from a recognized institution or organization.
2–3 years of prior experience in a cGMP- or FDA-regulated industry.
At least 1 year of supervisory or management experience.
Successful completion of certified in-house qualification programs.
Experience training personnel on aseptic techniques and appropriate gowning techniques.
Ability and willingness to walk, stoop, stand, bend, and lift up to 50 pounds throughout each shift, with or without reasonable accommodation.
Knowledge of compliance and quality requirements in the 503B pharmaceutical industry and cGMPs, with demonstrated problem-solving and resolution skills.
Must be currently authorized to work in the United States on a full-time basis; Quva cannot sponsor work visas.

Nice To Haves

Bachelor’s degree in life science or another related field.
Computer skills training.
Experience with Microsoft Suite.
Experience with ERP software.

Responsibilities

Run operations to meet or exceed delivery performance objectives for products or projects.
Supervise staff performing daily work and ensure operators comply with validated parameters, standard operating procedures, cGMP regulations, and safety requirements; provide constructive feedback.
Counsel, train, and develop technicians to support efficient performance and foster teamwork and open communication.
Complete in-process checks and verifications in accordance with Standard Operating Procedures.
Review batch records, logs, and other documentation to ensure processes are accurately recorded and comply with policies, procedures, and Good Documentation Practices.
Develop technician training programs and ensure operator training is conducted.
Troubleshoot or resolve issues affecting daily or weekly deliverables and take ownership of achieving results.
Review operational performance and drive improvement opportunities.
Initiate and execute change-control assignments supporting continuous improvement for equipment, documentation, or processes.
Drive Quality Management System assignments, including CAPA, deviations, change control, and GMP tasks, to on-time closure.
Report and initiate production schedule changes and request equipment or facility repairs or modifications.
Prioritize and plan work activities, set goals and objectives, and organize or schedule other people and their tasks.