Technical Data Specialist
4 weeks ago
Location: Remote
Type: Contract
Job Description:
ROLE SUMMARY:
The Technical Data Reviewer will be responsible for reviewing data from physical and dimensional testing of commodities using wet chemical techniques and instrumental analyses. This includes visual evaluations, titrations, pH measurements, AA, HPLC, GC, and UV/Vis among other analyses. The ideal candidate will also be responsible for preparing solutions, performing analyses, recording and processing data in accordance with DEA, FDA, and ICH guidelines as needed.
ROLE RESPONSIBILITIES:
- Functions as a dedicated data reviewer for the Chemical Quality Lab.
- Prioritizes data review and testing with guidance from Data Coordinator or supervisor.
- Assists in monitoring laboratory metrics associated with turnaround goals.
- Prepares solutions required for testing, performs analysis, records data according to cGMPs, performs calculations, and enters results into LIMS system.
- Provides support to assure lab safety and compliance, either through safe use of chemicals and/or the recognition of DEA, FDA, OSHA, and ICH compliance issues.
BASIC QUALIFICATIONS:
- Bachelor of Science in Life Science, e.g. Chemistry, Biology, Microbiology, etc.
- Minimum of 5 years of experience in a Quality Control or RD laboratory and experience with a wide variety of analytical techniques, e.g. HPLC, GC, AA, UV-VIS, etc. and biological techniques, e.g. BET, antibiotic potency, sterility, etc.
- Knowledge of cGMPs and regulations outside of the US.
- Good communication, organization, and computer skills are required.
- Knowledge of LIMS, Empower, and Microsoft Office programs is desired.
REQUIRED QUALIFICATIONS:
- Minimum of 1 year data review experience with minimum 5 yrs Lab Experience in pharmaceutical manufacturing environment.
- Minimum of 4-5 years of experience reading and interpreting chromatographic data.
- ICP-MS Experience Preferred
Required Technical Experience:
- HPLC basic experience AA/ICP-MS
- Empower3 Experience
- Chromatography Knowledge
- cGMP
Day 2 Day:
- HPLC
- GC
- AA/ICP-MS-Data Review
Education: 4-year Degree - Bachelor of Science in Life Science (e.g. Chemistry, Biology, Microbiology, etc.)
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