Manager, Chemistry

Fresenius Kabi•Wilson, NC

9d•Onsite

About The Position

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.

Requirements

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.
Experience level, education, knowledge, skills, and abilities.

Nice To Haves

Experience with ISO 14001, ISO 50001, and ISO 45001 standards.

Responsibilities

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.