Quality Assurance Associate at The Fountain Group

The Fountain Group is currently seeking a ­­­­­­­­Quality Assurance Associate for a prominent client of ours. This position is located in ­­Waltham, MA. Details for the position are as follows:

Pay Range: $42 - 62/hr depending on experience
Contract: 1 year with possible extension and/or conversion
Hybrid position (3 days onsite / 2 days remote per week)

Job Description:

• Review executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials.
• Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.
• Ensure that all requirements, as stipulated in the appropriate QTA, have been met.
• Issue/Review documentation, i.e. Deviations, CAPAs, OOS (out of spec) etc., as they occur.
• Write and revise SOP, forms, WI, and any other document types. Assist with internal and external audits.
• Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.

Qualifications:

• Bachelor's Degree with 5+ years experience or High School/GED with 8+ years experience
• Quality assurance experience within the pharmaceutical industry

If you are interested in hearing more about the position, please respond to this posting with your resume attached or contact me at 813-356-0199.

Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.