Technical Data Reviewer

Job Title: Technical Data Reviewer
Location: Rocky Mount, NC

Type: Contract
 

Job Description:

ROLE SUMMARY:
The CQ Technical Data Reviewer reviews data from physical and dimensional testing of commodities wet chemical techniques and instrumental analyses. Included in this review are visual evaluations titrations pH measurements AA HPLC GC and UV/Vis among other analyses. In addition to data review this individual could be responsible for preparing solutions performing analyses as well as 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.
• As needed 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.)