Supervisor, Formulation (2nd Shift)

Fresenius Kabi USA, LLC; Grandyle Village (NY); On-site; USD 74,000 - 103,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) with company contribution

Wellness program

Job summary

Fresenius Kabi USA, LLC in Grand Island, NY is seeking a Formulation Supervisor to oversee the liquid parenteral formulation suites and related controlled environment area. You will supervise 12–15 direct reports and ensure production schedules and quality standards are met in a cGMP framework.

The role requires a strong background in SOPs, cGMPs and MS Office, with the ability to lift up to 50 lbs and work the 2:00 PM–10:30 PM shift. We offer a competitive salary, bonus and benefits package.

Qualifications

• Pharmaceutical experience in compounding preferred.
• Working knowledge of SOPs and cGMP regulations.
• Ability to regularly lift 25–50 lbs.

Responsibilities

• Supervise the Grand Island formulation suites and related area.
• Ensure systems and resources meet production schedules and specs.
• Maintain training and safety compliance for staff.
• Review procedures and audit actions, close CAPAs timely.
• Collaborate with HR on hiring and performance management.
• Coordinate with Technical Services to reduce downtime and improve equipment reliability.
• Manage materials with SAP and coordinate environmental, PM, and calibration schedules.

Skills

SOPs & cGMP

Education

High School diploma or GED

BS/BA in Science related discipline

Tools

Microsoft Office

Job description

Job Summary

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 atwill, 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.