Fresenius-posted 7 months ago
$73,614 - $103,000/Yr
Full-time
Grand Island, NE
Ambulatory Health Care Services

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. 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.

  • Supervise, direct, and coordinate the Grand Island formulation suites and surrounding controlled environmental area.
  • Ensure systems, equipment, and resources are in place to meet production schedules.
  • Manufacture products to specification in accordance with SOP's, DEA, OSHA, and cGMP's regulations.
  • Review and revise area SOPs to encompass changes in procedure.
  • Train employees on area-specific curricula and company policies.
  • Ensure a safe work environment and that personnel work safely.
  • Complete corrective actions for investigations and audit observations in a timely manner.
  • Review Batch Records for the area within designated time expectations.
  • Collaborate with HR on policy changes, hiring, and performance management.
  • Work with Technical Services/Maintenance to improve equipment reliability.
  • Manage inventory and component problems with Material Management and Quality.
  • Ensure environmental monitoring and maintenance schedules are met.
  • High School diploma or GED OR BS/BA in Science related discipline or equivalent relevant work experience is preferred.
  • 4-5 years of pharmaceutical experience in compounding.
  • Working knowledge of SOP's and cGMP's rules and regulations.
  • Proficiency in Microsoft Office required.
  • Ability to work with Antineoplastic products and assist in the Nanotechnology department.
  • Ability to regularly lift 25 lbs and occasionally lift 50 lbs without strain.
  • Medical coverage
  • Dental coverage
  • Vision coverage
  • Life insurance
  • Disability insurance
  • 401K with company contribution
  • Wellness program
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