Location: Buena, NJ
The Data Reviewer is responsible for the review of all raw data related during method development, method validation and R&D stability in the Product Development Laboratory. They will also be responsible for reviewing documents such as analytical test methods, protocols, reports and Deficiency Responses as needed.
Reporting Relationships: Individual Contributor
- Responsible for all data generated from instruments such as HPLC, GC and other testing.
- Responsible for review of documentation such as analytical methods, protocols and reports.
- Review data for correctness and ensures that the documentation is as per cGMP requirements.
- Maintain and follow all laboratory systems, GMPS and safety requirements.
- Assist in the evaluation and interpretation experimental data.
- Compile, maintain, review and interpret analytical and statistical data. Assist with generating high quality technical documents required for method validation and ANDA submissions.
- Adhere to safety and housekeeping requirements.
- Prepare and review SOPs, as required.
- Keep supervisor informed of all key quality findings and issues. Seek guidance on resolution of complex issues
- Assume other activities and responsibilities as directed.
- Minimum BS in Organic Chemistry or related discipline with at least 3-5 years of experience in the Pharmaceutical Industry or equivalent experience.
- Knowledge of cGMPs, and good documentation practices.
- Strong foundation in the principles and applications of HPLC and detection systems, GC, UV/VIS, and other methodologies.
- Strong problem-solving skills.
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team members and company priorities.
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Good written and oral communications.
- Demonstrated ability to work on multiple projects and meet timelines.
- 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.