Quality Assurance Associate
Wayne Metro Area, NJ
Perform Quality/Compliance related activities that support the PSS organization. Provide support for the development of Quality processes that ensure compliance with established standards and guidelines as well as tracking, trending and reporting on the respective processes. Interaction with both Quality organization as well as other supporting functions such franchises and Drug Safety. Responsibilities include project management, metrics, implementation of selected quality systems, and training programs. Under the Americas Region Liaison: Act as the main point of contact between Quality function and other selected units and facilitate interactions and follow ups. Provide support including projects, processes, metrics. Facilitate and support the roll-out of training programs. Conduct gap assessments and perform baseline assessment, on specific Drug Safety Deliverables and manage implementation/coordination of remediation actions with 3rdparty vendors.
Develop and manage project plans and deliverable requirements as assigned.
Quality Assurance/Quality Control professional. Minimum 7 years related pharmaceutical industry QA/compliance experience with a scientific background and solid understanding and knowledge of GMPs and Regulatory Guidelines. Quality System Administration experience preferred. Must be proficient with all quality standards and compliance requirements. Proficiency in project management skills
Bachelor s degree in Biology, Chemistry, Microbiology, or related science or equivalent combination of education and experience