Quality Assurance Compliance Specialist

Experience:

• Minimum of 6 years experience in biotech, pharmaceutical, or related industry or the equivalent combination of education/training and experience.
• Must have attention to detail and good investigation, problem solving, and organizational skills.
• This position requires a knowledge and experience with GxP processes related to managing vendors, partners, and suppliers.
• Familiarity with FDA Quality System Regulations and Pharmaceutical guidelines, 21 CFR Part 210 & 211, US and EU regulations, ICH guidelines and other industry standards. ISO understanding is a bonus.
• Administrative experience in organizing and maintaining vendor and audit related records.
• Proven organizational skills to obtain data across multi-functional groups and present results in a consolidated and clear manner.
• Keeps Management informed of status of assigned projects.

Knowledge/Skills:

• Strong written and oral communication skills.
• Excellent attention to detail and organizational skills.
• Ability to influence decision makers and utilizes sound problem solving skills to recommend options and implement effective solutions.
• Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
• Ability to contribute to the development of company objectives and key performance indicators.
• Strong user of Microsoft Office applications.