Manager, Chemistry

Fresenius Kabi USA; Wilson (NC); On-site; USD 91,000 - 127,000; Full time

Benefits offered by this job

401(k) with company contributions

Medical, prescription, dental and 10?

Vision coverage

Paid vacation, holidays and personal),

Job summary

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

Responsibilities

• 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.

Job description

Job Summary

The Manager, Chemistry will be responsible for the management of all activities associated with testing of raw material and finished goods to meet established and expected quality, regulatory and customer requirements. Interact with Manufacturing and Quality Assurance on a routine basis.

Salary Range: $90,816 - $126,991

Position is eligible to participate in a bonus plan with a target of 10% of the base salary.

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

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• 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.

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.