Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Participates in developing Standard Operating Procedures to ensure quality.
 
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
 
Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products. Responsibilities may include the final release for all manufactured 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 routine checkpoints for new products and processes.
 
May assist compliance audits as required. May interface with contract manufacturers to address documentation and compliance issues.
 
Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed.
 

 
Preferred:
 
Understanding and application of QA principles, concepts, industry practices, and standards. Assignments are routine where analysis of situation or data requires a review of identifiable factors.
 
Develops solutions to moderately complex problems. Must be able recognize routine deviations from accepted practice is required.
 
Applies knowledge of current Good Manufacturing Practices (cGMPs) and/or Good Laboratory Practices (GLPs) on a daily basis.
 
With guidance exercises judgment within well defined and established procedures and practices to determine appropriate action.
 
Normally receives no instruction on routine work, general instructions on new assignments. Strong verbal, technical writing and interpersonal skills are required.
 

 
Specific Education and Experience:
 
Typically requires a BA or BS degree
 
1-3 years of related work experience in an FDA regulated environment
 
Good computer skills including Microsoft Windows and Office
 
Excellent written and oral communication skills
 
Must be a team player
 
Must be detail oriented