Location: Buena, NJ
Responsible for performing the validation, verification and transfer of analytical methods into Quality Control. The Method Transfer Chemist will also be responsible for reviewing and approving method transfer protocol, reports, methods and justifications of specifications that are provided by R&D.
- Responsible for the scheduling/performing all method transfers that are required from R&D.
- Responsible for reviewing and approving method transfer protocol, reports and justification of specifications that are provided by R&D.
- Responsible for writing verifications performed by the Quality Control department.
- Write and contribute to the content of Standard Operating Procedures, validation protocols/reports, test methods, raw material/bulk/finished product specifications and other technical documentation.
- Responsible for comprehensive recording and/or review of test results, initiation and participation in investigations, and entry of data into computer systems for tracking purposes.
- Monitor current analytical methods and assist in improvements and amendments according to cGMP practices.
- Responsible for maintaining all required reagents and standards for ongoing projects.
- Works with the QC supervisors/managers 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 Lead Investigation Scientist 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
- 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.
- Confident person with excellent organizational skills.
- Demonstrated ability to work on multiple projects and meet tight timelines.
- 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