QA Specialist - Formulation

QA Specialist - FormulationCandidates should have experience with tablets and capsule formulations, clinical products stage I - III, working with contract manufacturing organizations, they are a virtual company so the candidate will give documentation feedback to external manufacturing organizations.Job Description:Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs)Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.Works with Research and Development during new product start-ups, and identifies checkpoints for new products and processes.Normally receives very little instruction on routine work, general instructions on new assignments.Additional Information:All your information will be kept confidential according to EEO guidelines.