Chemistry Lab Manager: Quality & Regulatory Lead

Fresenius Kabi USA; Wilson (NC); In loco; USD 91.000 - 127.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k) with company contributions

Medical, prescription, dental and 10?

Vision coverage

Paid vacation, holidays and personal),

Descrizione del lavoro

Fresenius Kabi USA in Wilson, NC is seeking a Manager, Chemistry to oversee testing of raw materials and finished goods to ensure regulatory and customer quality requirements. The role interacts with Manufacturing and Quality Assurance, with a salary range of $90,816–$126,991 and a target bonus of 10% of base pay.

Final pay depends on experience, education, knowledge and abilities. The benefits package includes 401(k) with company contributions, medical/dental/vision coverage, paid time off, EAP

Mansioni

• Directs and prioritizes lab teams to ensure timely, accurate testing for raw materials, in-process and finished goods to meet FK USA and FDA quality requirements.
• Oversees staff administration to train, develop and motivate team while ensuring adherence to quality standards.
• Plans and coordinates training to develop cross-trained, self-directed teams aligned with total quality management.
• Stays current with analytical chemistry requirements, methods, and pharmaceutical changes.
• Evaluates corrective actions for out-of-specification (OOS) or out-of-trend (OOT) events.
• Provides QC recommendations for new processes or troubleshooting existing processes.
• Assists in development, administration and maintenance of departmental budgets.
• Represents the department in cGMP inspections and audits as required.
• Coordinates staff to conform to cGMP and FK USA policies and procedures.
• Fosters development of people, improves methods, and supports goals.
• Participates in annual product review documents for the department.
• Fosters a work environment that develops people and improves processes.
• Attends and represents the department at management review meetings.
• Collaborates with peers to harmonize processes improving compliance, capability and capacity.
• Ensures staff awareness of ISO 14001/50001 EMS and promotes continual improvement.
• Keeps health, safety and environmental requirements under ISO 14001.
• Ensures energy management compliance under ISO 50001.
• Ensures OH&S compliance per ISO 45001.

Descrizione del lavoro

Fresenius Kabi USA in Wilson, NC is seeking a Manager, Chemistry to oversee testing of raw materials and finished goods to ensure regulatory and customer quality requirements. The role interacts with Manufacturing and Quality Assurance, with a salary range of $90,816–$126,991 and a target bonus of 10% of base pay.

Final pay depends on experience, education, knowledge and abilities. The benefits package includes 401(k) with company contributions, medical/dental/vision coverage, paid time off, EAP