Supervisor, Formulation (2nd Shift)

Fresenius Kabi USA•Grand Island, NY

1d•$73,614 - $103,000•Onsite

About The Position

Responsible for the overall supervision, direction, and coordination of the Grand Island formulation suites and the surrounding controlled environmental area associated with the formulation of liquid parenterals. Ensures adequate systems, equipment and resources are in place to meet production schedules, and that products are manufactured to specification and in complete accordance with applicable SOP’s, DEA, OSHA and cGMP’s regulations. This position directly supervises 12 to 15 direct reports accountable for formulating liquid products against delivered production schedules and compliance regulations. Staff development, hiring, disciplinary processes, and direction to complete assigned activities are required. The formulation supervisor ensures the safe and quality focused work environment while accepting accountability for all activities within this position’s control. Investigation work, corrective, preventative, and practice versus procedure auditing as needed.

Requirements

High School diploma or GED. BS/BA in Science related discipline or equivalent relevant work experience is preferred.
4-5 years of pharmaceutical experience in compounding preferred.
Working knowledge of SOP’s and cGMP’s rules and regulations.
Proficiency in Microsoft Office required
Must be able to work with Antineoplastic products and assist in the Nanotechnology department.
Heavy lifting is required. (Ability to regularly lift 25 lbs and occasionally lift 50 lbs without strain.)

Nice To Haves

BS/BA in Science related discipline or equivalent relevant work experience is preferred.
4-5 years of pharmaceutical experience in compounding preferred.

Responsibilities

Ensures adequate systems are in place to effectively manufacture Bulk product, and clean/store/prepare equipment and compounds.
Ensures all area SOPs are reviewed/revised to encompass any changes in procedure and/or two-year review.
Ensures adequate resources are available to clean and prepare equipment.
Ensures all area personnel are current in their training requirements; Trains employees to area-specific Curricula and company policies and procedures.
Ensures a safe work environment and that all personnel work in a safe manner.
Ensures corrective actions for investigations and audit observations are completed in a timely manner. Ensures all documentation is correct and addresses errors effectively and expeditiously. Completes Batch Record review for area in the designated time expectations.
Works closely with HR on policy changes, interpretation and execution, hiring of new employees, employee disciplinary action, performance appraisals and performance management.
Works with Technical Services/Maintenance to reduce downtime and improve equipment reliability; Assists with design of new systems/facilities related to the department.
Works closely with Material Management and Quality regarding component problems and inventory maintenance. In addition to each complexes inventory management and movement via SAP modules.
Works closely with Environmental, Maintenance, Metrology, and Validation to ensure area environmental monitoring, PM, calibration, and re-qualification schedules are met