Chemistry Quality Associate II needed at our client, a generic prescription medication provider located in Eatontown, NJ. The Chemistry Quality Associate II position is a temporary opportunity, lasting approximately 3-6 months.
Conduct laboratory investigations, review related data, interview personnel and write report. Trend errors and provide monthly reports to QA/QC management
Provide weekly status of laboratory investigation reports (LIR)
Conduct Annual Product Reviews, prepare and evaluate data trends and provide an expert advice to teams involving in the troubleshooting and program solving activities
Prepare, review, and revise, as required, SOPs, protocols, reports, and other appropriate documentation for proper functioning of the department
Assist in training staff and assures training requirements are met and records are up to date. Assists and writes protocols for LIRs and method evaluations
Assist in audits by providing answers to questions regarding laboratory investigations posed by any inspector
Exposure to confidential/sensitive information and policies/procedures
Participate in pro-active functions that impact the lab operations and production, increase efficiency, solve problems, generate cost savings and improve quality
Conduct weekly investigation meetings with QA/QC management
Exceptional organizational skills and ability to plan and implement resolutions to technical problems. Familiarity with auditing techniques, interpreting regulations and quality systems
Understand scientific strategies and be able to invent new methods or new avenues of investigation
Good interpersonal/communication/influencing/negation skills.
Good project management skills
Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
Bachelor's degree in the Sciences or in Chemistry, 3-5 years experience in Quality Assurance or QC/QA analysis
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