Clinical - QA Associate, Clinical Studies

II. Essential Functions

• Responsible for inspection of incoming materials for GMP production
• Aid with packaging floor activities for primary and secondary (equipment/room approval, facility compliance, auditing, label inspection, line clearance, etc.)
• Review production batch records, logbooks and other associated documents
• Perform Quality verification of just-in-time labeling activities
• Handle document issuance, scanning, filing and archival activities
• Revise SOPs, Work Instructions and Forms as needed
• Assist in executing efficiency improvement projects with guidance
• Ensure products are manufactured, packaged, and tested according to applicable FDA guidelines, GXPs regulations and internal SOPs
• Participate in Quality programs, procedures and controls to ensure products conform to established standards and agency guidelines
• Ensure timely and compliant gathering of data, investigations and deviations
• Follow Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines
• Respond and interact with internal and external clients professionally and promptly
• All other duties as assigned

Position Requirements

• Education or Equivalent: Associate’s degree or equivalent knowledge and experience
• Experience: Six Sigma or ASQ certification preferred
• Knowledge/Skills Requirements:
• Ability to follow and provide a variety of instructions furnished in written, oral, diagram, or schedule form
• Must be able to use existing procedures to solve routine and non-routine problems
• Must be able to utilize all elements of the quality system to identify, classify and control the status of incoming materials
• Recognize unmet needs within department and business
• Must anticipate and identify unmet customer needs
• Be able to proactively address work issues at the individual and team level
• Mathematical and scientific reasoning ability
• Ability to identify aberrant data and potential quality/compliance concerns escalating to management
• CSD-JD-QA Associate – Clinical Supplies v1.0
• Excellent written and verbal communications skills with internal and external customers, peers and managers
• Lead by example according to our values and culture
• Ability to collaborate with peers and demonstrate leadership capabilities in a matrix environment
• Strategy is focused on personal time management and efficiency
• Well organized with ability to multitask
• Ability to work effectively under pressure to meet deadlines

Physical Requirements

• On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds
• Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently
• May require the use of a respirator

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