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.
Salary Range: $73,614 - $103,528
Position is eligible to participate in a bonus plan with a target of 6% 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.
- 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
R EQUIREMENTS
- 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.
- Demonstrated knowledge of Statistical analysis as it pertains to product stability and determination of shelf-life is plus.
- 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
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution , and wellness program.
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.
