Manager Quality Assurance

Lupin•Coral Springs, FL, FL

10d•Onsite

About The Position

The Quality Assurance Manager reports to the Director of Quality, Global Inhalation, and directly oversees Quality Assurance activities in manufacturing and packaging. The role monitors shift Quality Assurance Technicians conducting in-process sampling of multiple finished dosage forms, incoming raw materials and component sampling, and documentation of Quality Assurance functions. The position is based with the Quality Assurance team in Coral Springs, Florida, and generally works in a warehouse or manufacturing environment.

Requirements

At least 5 years of prior experience in a Quality Assurance role.
Bachelor’s degree in a scientific or related field.
Excellent communication skills.
Strong attention to detail.
Commitment to high-quality work and diligent adherence to Standard Operating Procedures.
Ability to manage and mentor a team effectively and adapt to changes in work duties.
Detail-oriented, thorough, methodical, and able to follow timelines.

Nice To Haves

Experience managing others in a Quality Assurance role.

Responsibilities

Conduct investigations of manufacturing and packaging deviations, write investigation reports, and route reports through QA management channels in a timely manner.
Conduct performance reviews and evaluations for shift Quality Assurance Technicians, including coaching and mentoring them.
Schedule shift Quality Assurance Technicians, manage overtime requests, and obtain management approval for overtime when needed.
Recommend SOP updates and identify opportunities to improve efficiency in daily Quality functions.
Ensure GMP compliance, adherence to SOPs, and compliance with safety and environmental guidelines.
Oversee and sometimes perform sampling and inspection of incoming raw materials, in-process intermediates, and purchased finished products, and submit samples to the QC laboratory for analysis.
Manage material status changes between Quarantine, Release, and Reject.
Monitor manufacturing equipment and rooms, as well as packaging lines and equipment, for cleanliness and approve them before operations begin.
Supervise and sometimes perform beginning, middle, and end in-process QA checks for manufacturing and packaging operations, assessing results against predetermined standards and batch record requirements.
Guide the QA Technician team in performing AQL inspections of finished dosage forms against predetermined Quality Attributes.
Manage collection and maintenance of samples from manufactured products, ensuring retain samples are appropriately stored for accountability, annual inspection, and retrieval.
Oversee sampling and proofreading of pharmaceutical labeling for conformance to standards, and issue approved labels to packaging lines.
Use QAMS, SABA (LMS), and SAP to track daily work activities and training.
Immediately address Quality issues raised by Quality Assurance Technicians.
Perform other QA duties as assigned.