Job Description

Job ID 190004XR
Available Openings 1
PURPOSE AND SCOPE:
Supervises and leads the QS Laboratory. Responsible for assuring the accuracy of test results such as analysis of raw material, functional testing, and final product testing. Responsible for assuring timely testing to support special projects such as validation; assuring the completion of test method validations in a timely manner. Act as Laboratory Lead
PRINCIPAL DUTIES AND RESPONSIBILITIES:
+ Supervise the daily operations of the team, including but not limited to: establishing mutual goals, assigning tasks and maintaining schedules.
+ Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
+ Ensure all employees within the assigned team(s) understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations; establishing and maintaining effective internal systems and controls to promote compliance.
+ Provide direct supervision of the assigned team(s) through ongoing leadership and guidance; partnering with Human Resources on employee matters.
+ Plan, coordinate, and direct testing methods for routine product release, R&D, product/process development and improvement of the QS laboratory.
+ Must be proficient in performing all applicable current test methods.
+ Monitor, review and determine disposition of applicable testing data and product.
+ Maintains proper GLPs and technique for handling laboratory reagents and instrumentation.
+ Assists in developing corrective and preventive actions in response to laboratory errors, deviations, non-conformances, customer complaints etc. involving laboratory results, to prevent recurrence of problems.
+ Maintain high standards for reagents, standards, indicators, etc.
+ Maintain laboratory reagent and supplies through ordering and vendor contacts.
+ Understand the theory behind all applicable instrumentation and maintains proficiency in instrument operation.
+ Keep familiar with applicable established methods and techniques.
+ Keep familiar with and follows plant SOP's, policies and standards including cGMP, ISO, and safety standards.
+ Maintain good documentation practices for all forms, protocol reports, and laboratory notebooks.
+ Ensure calibration and proper operation of applicable laboratory equipment.
+ Provide technical support for instrumentation and documentation.
+ Assist in design of engineering studies, stability studies and validations
+ Monitor and train employees to current policies/procedures, and compendia test methods.
+ Proficient in maintenance of applicable lab instrumentation and documentation.
+ May assist in conducting audits of suppliers of raw material.
+ Responsible to review the quality of work product and data generated by technicians.
+ Act as laboratory liaison with other departments as required.
+ Responsible for the quality of his/her work product.
+ Observe good housekeeping practices in compliance with FDA and ISO standards.
+ Maintain general housekeeping of working area and plant.
+ Follow all Fresenius Policies
+ Technically proficient in the specific department. Requires full knowledge of own area of functional responsibility.
+ Works on issues of limited scope; follows established practices and procedures in analyzing situations or data from which answers can be readily obtained. Has a limited range – local within the department.
+ Receives predetermined work assignments that are subject to a moderate level of control and review. Role primarily focuses on tactical execution of routine situations.
+ Monitors daily operations of a unit or sub-unit. A portion of time is normally spent performing individual tasks related to the unit or sub-unit.
+ Supervises/directs daily operations of subordinates to complete assignments using established guidelines, procedures and policies. Provides immediate supervision of a unit or group of employees, assigning tasks, checking work at frequent intervals, and maintaining schedules.
+ Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations.
+ Decisions have direct impact on work unit operations; usually limited to “how to” execute within defined processes. Erroneous decisions or failure to achieve may cause delays in schedules.
+ Interacts daily with subordinates and/or functional peer groups. Interaction normally involves the exchange or presentation of factual information.
+ Assist with various projects as assigned by a direct supervisor.
+ Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific
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