Supervisor, Formulation (2nd Shift)

Fresenius Kabi USA

Town of Grand Island (NY)

On-site

USD 74,000 - 103,000

Full time

4 days ago
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Benefits offered by this job

Medical coverage
Dental coverage
Vision coverage
Life insurance
Disability
401K with company contribution
Wellness program

Job summary

Fresenius Kabi USA on Grand Island, NY seeks a Formulation Supervisor to oversee the liquid parenteral formulation suite and related environmental areas. You’ll ensure equipment readiness, schedule adherence, staff supervision, and compliance with SOPs, DEA, OSHA and cGMP regulations.

Responsibilities include training, safety, audit follow-ups, and collaboration with HR, Maintenance, and Quality to maintain production efficiency and quality. Salary range and bonus apply; shift is 2PM-10:30PM.

Qualifications

  • High School diploma or GED. BS/BA in Science related discipline or equivalent relevant work experience preferred.
  • 4-5 years of pharmaceutical experience in compounding preferred.
  • Working knowledge of SOPs and cGMPs 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 ( regularly lift 25 lbs and occasionally 50 lbs ).

Responsibilities

  • Ensure adequate systems to manufacture Bulk product and prepare equipment.
  • Review and revise area SOPs to include changes in procedures.
  • Ensure resources to clean and prepare equipment.
  • Train personnel to area curricula and policies.
  • Maintain a safe work environment and ensure safety.
  • Complete investigations and audit actions timely; perform batch record reviews.
  • Collaborate with HR on policy changes and hiring processes.
  • Work with Technical Services/Maintenance to reduce downtime and improve equipment reliability.
  • Coordinate with Material Management and Quality on component problems and inventory.
  • Ensure environmental monitoring, PM, calibration, and requalification schedules are met.

Skills

Leadership
Staff development
Training
Problem solving

Education

BS/BA in Science
High School Diploma or GED

Tools

Microsoft Office
SAP

Job description

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.

Salary Range: $73,614-$103,000 + 6% annual bonus

Hours: M-F; 2PM-10:30PM

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

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

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.)
Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Fresenius Kabi USA is a global healthcare company dedicated to improving patient care through innovative products and technologies for critically and chronically ill patients.

Pharmaceutical Manufacturing Chemical Manufacturing Manufacturing

Company size 1,001–5,000 employees

Company type Public company

Total funding 0

Momentum

Team growth

Momentum

2% in 12 mo

1,747 employees on LinkedIn

Apr 22 May 26

Capital

Funding history

Footprint

Where they work
Apply For This Role

Company Fresenius Kabi USA

Location Grand Island, New York, United States

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