Location: Buena, NJ
Responsible for the execution of method transfers between departments (QC and RD), and between vendors and contract laboratory. Also, responsible to troubleshoot issues pertaining to analytical testing and methods and executing any investigational testing in the QC laboratory or contract laboratory.
Reporting Relationships: Individual Contributor
- Responsible for performing method transfer testing between multiple departments, manufacturing vendors and contract laboratory.
- Responsible for writing and reviewing method transfer protocols and reports
- Responsible for the writing, reviewing and designing SOPs and Methods updates as needed
- Review raw data generated by the laboratory to ensure compliance to good documentation practices.
- Responsible for the performing investigational testing per protocols.
- Troubleshoots HPLC/GC testing with bench chemists.
- Works with the QC supervisors in all laboratory areas to ensure method issues are addressed, investigated and resolved in a time manner.
- Requires a highly collaborative work style, with supervisory personnel as well as chemists.
- Keep the QC Supervisors, QC Managers and Investigation Scientists informed of all key quality findings and issues as needed.
- Assumes other activities and responsibilities from time to time as needed/directed, this may include assisting other sub-groups in QC and R&D unit under special circumstance where assistance is needed.
- Bachelor’s degree, and a minimum of 1-2 years of bench/ technical related experience.
- Demonstrated ability to work on multiple projects and meet tight timelines.
- Knowledge of cGMP requirements.
- Strong knowledge of Microsoft Word and Acrobat (PDF) documentation systems.
- Confident person with excellent organizational skills.
- Collaborative work approach.
- Demonstrates a high level of professionalism, cooperation and willingness to support team and company priorities in a fast-paced laboratory setting.
- Strong interpersonal skills.
- Good written and oral communications.
- 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.