Supervisor, QC Analytical Sun to Wed

Position: Supervisor, QC Analytical Sun to Wed 6:30 AM to 5:00 PM
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective:
The QC Analytical Supervisor will have responsibility for supporting all activities in the Quality Control Laboratory including completing the majority of the peer review in the department and approving the majority of procedures used in the analytical department. The work includes the testing of in-process samples, finished product samples and raw materials. The QC Analytical Supervisor will communicate with clients regarding Out of Specification and other Quality System Events.

The person in this position has knowledge of commonly-used analytic concepts, practices, and procedures within the field of his/her responsibilities. Also, must be familiar with cGMPs as they relate to analytical test methodologies and practices.

Essential Duties and Responsibilities:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
* Prioritize and distribute work to the analysts working in the QC Analytical laboratory
* Conduct OOS and customer complaint investigations
* Complete peer review of work executed within the analytical laboratory
* Train new Employees
* Routine Analytical testing of samples supporting incoming raw materials, in-process production and finished product testing
* Performs analytical testing using HPLC, Karl Fischer, Particle Size Analyzer, UV Vis, Densitometer, Osmometer and other instrumentation as required
* Perform instrument calibrations and preventative maintenance as needed
* Documents laboratory work using laboratory worksheets/notebooks. Documentation must be detailed and meet CGMP requirements
* Write, review and revise SOPs as required
* Other duties as assigned or required Special Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
* Routine work requires walking, standing, bending, reaching, climbing stairs, lifting or carrying objects that typically weigh less than 50 lbs.
* Capacity to work on several tasks simultaneously.
* Able to organize and prioritize work activities.
* Must be able to walk and drive between locations
* Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
* Comfortable with working/handling of hazardous materials Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Works closely with Quality Assurance and Quality Control staff in performing varied work procedures and activities.
* Interacts with Operations staff, Research and Development staff and clients on a regular basis.
* Supervises the employees in the QC Analytical departmen
* TRAVEL -