Supervisor, Chemistry and Stability

Fresenius Kabi USA•Wilson, NC

About The Position

The Chemistry and Stability Supervisor will be responsible for the supervision of daily activities in the Chemistry and Stability Departments. The Chemistry and Stability Supervisor will assure that activities associated with the testing, release, and results reporting of materials, products and components meet established and expected quality, regulatory and customer requirements. This position is also responsible for overseeing the activities of Stability Coordination staff. The position directly interfaces with other QC Laboratory Supervisors responsible for generating data to be reported for stability studies. Additionally, the position is an interdepartmental liaison which supports virtually all aspects of the business, as it relates to the compliance of the stability program, the furnishing of stability information, providing consultation on product behavior, and managing special projects to achieve company initiatives. The Chemistry and Stability Supervisor will regularly interact with departments on site and at a corporate level such as Operations, Packaging, Quality Assurance, Stability, Validation and Regulatory Affairs.

Requirements

B.S. in Chemistry or related Science
Five – Ten years of progressive pharmaceutical lab experience
Equivalent combined of education and experience in pharmaceutical manufac turing, related industrial or clinical experience accepted.
Excellent verbal and written communication skills are essential.
Knowledge of department processes and procedures, and a clear understanding of regulatory requirements.
A demonstrated ability to lead in a team and effect solutions to accommodate competing goals.
Flexibility, adaptability, and strong desire to work in a dynamic environment.
Must possess skills to analyze analytical results and solve problems as a backup to Stability Manager

Nice To Haves

Demonstrated knowledge of Statistical analysis as it pertains to product stability and determination of shelf-life is plus.

Responsibilities

Coordinate the training and development of department personnel.
Aid in the assignment of personnel Goals & Objectives.
Perform personnel reviews and administer disciplinary actions as required.
Promote a positive work environment for personnel morale and achievement of goals & objectives.
Address personnel issues with assistance from department Management and Human Resources.
Prioritize and track progress of daily activities in functional area for timely release of materials, products, components and/or information.
Assure that the integrity of materials, products, components and data is maintained.
Assure staff conformance with cGMP and FK USA procedures and policies.
Facilitate department investigations for non-conforming materials, products and/or components.
Support investigations and corrective/preventative actions for the Company.
Provide technical guidance on existing and improvements to processes, products, procedures and methods
Assist with development and maintenance of department budget.
Compile information required for Management Reviews and Audit Responses.
Represent department at meetings.
Reviews Stability Testing Protocols for accuracy and compliance.
Reviews Stability sections of regulatory submissions prior to filing with the agency.
Assesses impact of Material Change Requests (MCR) to current stability commitments.
Consults with Regulatory Affairs on interpretation and execution of stability commitments.
Tracks acquisition of lots into stability program to ensure all required batches are requested and acquired for regulatory requirements.
Reviews stability protocols for accuracy.
Manages approving, expiry calculation, stability summary, and archiving processes.
Reports department metrics for Quality Management purposes as required
Assumes area ownership of stability chambers and is responsible for investigating excursions, initiating critical work to be performed, and assessing impact to product stored within.
Review and manage the regulatory annual reports
Provides laboratory supervision support to assign testing, review documentation, and track completion of assignments.
Develops staff to achieve both departmental and personnel goals.
Identifies and solves personnel issues.
Support investigations (OOS, OOT, Deviations, Complaints, etc.) as required.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities