Location: Buena, NJ
Responsible for the scheduling, testing and review of the raw materials and packaging components that are submitted to the Quality Control laboratory.
- Responsible for the testing coordination and technical support of the raw material and packaging inspection portions of the Quality Control laboratory.
- Responsible to ensure all testing is completed and released in a timely mannerly.
- Review raw data generated by the laboratory to ensure compliance to good documentation practices.
- Work with production and manufacturing to ensure timely release of raw material and packaging components, as needed.
- Create and revise raw material sampling cards, directing the sampling personnel on the proper PPE, sampling requirements and amount of sample required for the laboratory.
- Schedule the required HPLC/GC testing in the analytical laboratory for upcoming raw material requirements based on the production schedule.
- Troubleshoots HPLC/GC testing with bench chemists.
- Responsible for maintaining compliance to GMPs in all areas.
- Assist QC department members with tasks as needed, this may include input for the raw materials testing lab as well as the stability program.
- Establish collaborative working relationships with product development, quality control and other groups to ensure consistency and suitability of analytical methods throughout the drug development process.
- Assist in the investigation of OOS/OOT data as needed.
- Keep Manager informed of all key quality findings and issues.
- Train and mentor junior staff.
- Provide guidance on resolution of complex issues to junior staff.
- Assume other activities and responsibilities from time to time as needed/directed.
- BS in Chemistry or related discipline, 3-5 years of pharmaceutical industry or laboratory experience.
- Strong foundation in analytical chemistry and quantitative analysis.
- Knowledge of cGMP requirements. Practical experience with document control, and QA support of manufacturing
- Strong knowledge of Microsoft Word and Acrobat (PDF) documentation systems.
- Excellent organizational skills.
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities in a fast-paced laboratory setting.
- Demonstrated ability to work on multiple projects and meet timelines.
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Good written and oral communication skills.
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs