Seeking a Quality Assurance Engineer for a premier manufacturer, packager, and distributor of over-the-counter pharmaceutical products and consumer healthcare goods based in Copiague, NY.
The ideal candidate has 3+ years Quality Assurance experience with a minimum of 2 years in the pharmaceutical industry. Must have strong knowledge of quality systems, tools and processes. Working knowledge of Oracle and LIMS systems preferred.
- Investigate manufacturing deviations. Derive root cause and create CAPAs as required
- Investigate manufacturing customer complaints
- Compile data for site QA metrics
- Prepare and/or revise QA SOPs
- Support calibration / maintenance program for supplements including verification activities
- Assist other Quality groups, including review of manufacturing batch records of bulk goods in adherence to cGMPs and site SOPs
Requirements
- Bachelor s degree in Scientific or related field
- Knowledge of FDA/cGMP regulations and guidelines
- Proficient in Microsoft Office
- Strong written and verbal communication skills, including Technical Writing
- Excellent planning, time-management, problem-solving, and organizational skills
- Strong attention to detail and ability to work independently with minimal supervision
- Ability to establish and maintain cooperative working relations.
Bachelor s degree in Scientific or related field Knowledge of FDA/cGMP regulations and guidelines Proficient in Microsoft Office Strong written and verbal communication skills, including Technical Writing Excellent planning, time-management, problem-solving, and organizational skills Strong attention to detail and ability to work independently with minimal supervision Ability to establish and maintain cooperative working relations.