Chemistry Lab Manager — Quality & Regulatory Leader

Fresenius Kabi USA; North Carolina; Sur place; USD 91 000 - 127 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Paid vacation

Holiday and personal days

Health benefits (medical, prescription

Dental and vision coverage

Life insurance

Disability insurance

Wellness program

Résumé du poste

Fresenius Kabi USA is seeking a Manager, Chemistry to oversee testing of raw materials and finished goods and ensure quality, regulatory, and customer requirements are met. The role interacts with Manufacturing and Quality Assurance to maintain standards.

The position leads laboratory teams, ensures staff training, and keeps current with analytical chemistry requirements, while supporting budgeting, inspections, and continuous improvement in a cGMP environment.

Responsabilités

• Directs and prioritizes the functioning of multiple laboratory work teams within the department to provide for the timely and accurate testing of raw materials, in-process and finished goods, to demonstrate that product meets FK USA and FDA regulatory quality requirements.
• Oversees the administration of staff to ensure that members are adequately trained, developed and motivated, and that they adhere to quality performance standards.
• Plans and coordinates training schemes leading to the development of cross-trained, self-directed work teams in line with total quality management concepts.
• Stays current with new and changing analytical chemistry requirements, methods, and pharmaceutical changes.
• Evaluates and decides upon corrective actions to be taken in response to OOS or OOT situations.
• Provides evaluation and quality control recommendations for new processes relevant to chemistry concerns or to troubleshoot existing processes.
• Assists in the development, administration and maintenance of the operating and capital budgets for the department.
• Represents the department with active participation in cGMP inspections and other audits as required.
• Coordinates departmental staffs so that all departmental obligations conform to cGMP and FK USA policies and procedures.
• Provide assistance to the organization within areas of expertise as needed.
• Provide a work environment for the development of people, the improvement of methods, and the achievement of personal, departmental, and company goals.
• Participate in the review of annual product review documents related to the department.
• Provide a work environment for the development of people, the improvement of processes, and the achievement of personal, departmental, and company goals.
• Attends and represents the department at the applicable management review meeting.
• Works with peers within the site and/or at other sites to develop and harmonize processes and procedures to improve/enhance the compliance, capability, and capacity.
• Ensures department personnel are aware of the Environmental Management and Energy Management Systems and promotes continual improvement taking accountability for the effectiveness of the Environmental Management and Energy Management Systems according to ISO 14001 and ISO 50001 standards.
• Responsible for ensuring that Health, Safety and Environmental requirements are met under ISO 14001 standards.
• Responsible for ensuring that Energy Management Requirements are met under ISO 50001 standards.
• Responsible for ensuring compliance to Occupational Health and Safety is met under ISO 45001.

Description du poste

Fresenius Kabi USA is seeking a Manager, Chemistry to oversee testing of raw materials and finished goods and ensure quality, regulatory, and customer requirements are met. The role interacts with Manufacturing and Quality Assurance to maintain standards.

The position leads laboratory teams, ensures staff training, and keeps current with analytical chemistry requirements, while supporting budgeting, inspections, and continuous improvement in a cGMP environment.