Scientist III (Data Reviewer), Quality Control (2nd shift, Tues-Sat, 12:30pm to 9pm

Role Summary

Scientist III (Data Reviewer), Quality Control (2nd shift, Tues-Sat, 12:30pm to 9pm)

Responsibilities

• Conduct routine and non-routine HPLC/GC analysis of raw materials, in process, and finished formulations according to standard operating procedures.
• Perform chemical analyses of product to ensure stability.
• Compile data for documentation of test procedures that may include microbiological and/or chemical assays, stability program testing and formulation studies.
• Calibrate and maintain lab equipment.
• Participate in the preparation of investigations, summaries and reports.
• May assist in developing testing methods.
• Review data obtained for compliance to specifications and report abnormalities.
• Revise and update standard operating procedures as needed.
• May perform special projects on analytical and instrument problem solving.
• Applies knowledge of good manufacturing practices, good laboratory practices and good record keeping practices on a daily basis.
• Follows written test methods and protocols.
• Process data, report data and prepare tables and graphs for the completed testing. Identify problems, e.g. out of trend data. Professional interactions are primarily within the QC organization.
• Responsible for observing all Company, Health, Safety and Environmental guidelines.

Qualifications

• BS Degree in a scientific discipline with minimum of 4-6 years related experience or Masters with 2-4 years or an equivalent combination of training and experience
• At least 5+ years' experience in a laboratory setting, preferably in pharma
• Minimum 5+ years’ experience in quality control systems
• Must have Empower experience
• Good written communication skills
• Understanding of GMPs and regulatory guidelines as they relate to the pharmaceutical products preferred
• Good interpersonal skills
• Access, Excel, Word and Power Point skills

Skills

• HPLC/GC analysis
• Laboratory data analysis and documentation
• Quality control systems
• Regulatory compliance (GMP)
• Analytical instrumentation maintenance

Education

• BS in a scientific discipline or related field; MS acceptable

Additional Requirements

• Working Hours: 12:30pm to 9pm, Tuesday to Saturday. Additional stipend earned for working Evening Shift and Saturdays.