Scientific Affairs Auditor/Coordinator

SUMMARY:

The individual performs auditing on works and results generated by QC and R&D chemists to ensure the accuracy of the results and compliance of Armstrong's existing procedures (SOP's) as part of cGMP.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

(other duties may be assigned)

• The SA Auditor/Coordinator will complete routine assignments and assist as needed on special projects and NCR/OOS investigations.
• The SA Auditor/Coordinator will:
• Review test results, study reports, and test method validation packages.
• Summarize laboratory results, including release tests, stability tests, and R&D drug development studies.
• Monitor test results for out of specification/out of trend for initiation of investigations or re-runs where necessary.
• Keep track of all laboratory raw data. Store raw data packages.
• Coordinate with QA department on QA activities, including document update, personnel training on new SOP's.
• Order laboratory supplies and chemicals as requested by laboratory chemists.
• Check and monitor test standards, solution, and chemicals in the form of a chemical inventory.
• Independently perform and initiate non-routine projects, including identifying problem areas and proposing solutions and methods for the improvement of accuracy and efficiency in the lab.

SUPERVISORY RESPONSIBILITIES: N/A

EDUCATION and/or EXPERIENCE:

Bachelor of Science in Chemistry or relevant scientific degree from a four-year college or university. Must have work experience in performing various wet chemistry tests. Experience in the use of UV/VIS, pH meters, and balances is required. Familiarity with HPLC, GC, and FTIF is preferred. Able to understand and perform analysis per written LTMs and SOP's. Working knowledge of cGMP's, in the pharmaceutical industry is preferred.

Pay: $25.25 - $31.65 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee discount
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Retirement plan
• Tuition reimbursement
• Vision insurance

Work Location: In person