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QC Supervisor

Quality Control


Job Description


PRIMARY TASKS:
•Coordinates the activities of stability group which includes the following activities
•Manages finished product release sample testing
•Assigns and/or performs sample testing within stability group
•Investigates OOS, OOT, and aberrant results
•Independently writes documents
•Independently reviews data, protocols, reports
•Works with R&D formulation and analytical personnel with regard to R&D stability study
•Assists with the annual product review
•Conduct performance evaluation of direct reports
•Fulfills administrative responsibility of Lab Manager, as needed
•Introduce new technology to the lab

SKILLS NEEDED :
•High level of confidence to complete difficult tasks
•Provides creative solutions to administrative and technical problems for the company
•High level understanding of cGMPs
•Understanding of ICH/FDA guidance for Impurities
•Understanding of Analytical Chemistry including but not limited to the following techniques and how to utilize them, as needed, for projects, both simple and complicated, as assigned
•HPLC
•Dissolution
•UV/Vis
•FTIR
•Sample Preparation Techniques
•GC
•Titration/electrode chemistry
•Others as appropriate
•Strong oral and written communication skills. Can clearly and concisely articulate details in a professional manner.
•Strong organizational skills. Must be able to manage multiple projects efficiently to meet deadlines
•Adaptable: Must be able to adapt to a changing environment.
•Accountable and fair: maintain a fair amount of accountability to themselves and their team.
•Maintains proper social etiquette and self-control when dealing with stressful situations.

EDUCATION/TRAINING :
•PhD in chemistry with at least 2 years of pharmaceutical industry experience
•MS in chemistry with at least 4 years of pharmaceutical industry experience
•BS in chemistry with at least 8 years of pharmaceutical industry experience
•BS in a related field with at least 10 years of pharmaceutical industry experience
•Recognized as a technical expert or resource throughout the company
•Frequently interacts with external departments
•Supervises multiple direct reports
•Mentor to multiple coworkers


PHYSICAL DEMAND/WORK ENVIRONMENT

Job requires sitting and standing as needed. Walking, primarily on a level surface, periodically throughout the day is also required. Reaching above shoulder height, below the waist and/or lifting may be required to file documents or store materials throughout the workday. Proper lifting techniques required. Activities may include occasional lifting up to 50 pounds for files, computer printouts and other mostly office related items.

The performance of this position occasionally requires exposure to manufacturing areas where, under certain circumstances, personal protective equipment such as safety glasses with side shields and hearing protection are mandatory. The primary environment will be ambient room temperature, office lighting and exposure to traditional office equipment as found in a typical office environment.

Job Type: Full-time

 

Location - Quality Control

 
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