Clinical - QA Associate, Clinical Studies

This is an on-site contract opportunity. 3 months with potential extension

Under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Follows established protocols and work plans. May be assisted by QA Specialists and Sr. Specialists. Comply with divisional and site Environmental Health and Safety requirements.
II. Essential Functions:
• Responsible for inspection of incoming materials for GMP production
• Assist with packaging floor activities for primary and secondary (equipment/room approval, facility compliance, auditing, label inspection, line clearance, etc.) 
• Reviews production batch records, logbooks and other associated documents
• Performs Quality verification of just-in-time labeling activities
• Performs document issuance, scanning, filing and archival activities
• Revises SOPs, Work Instructions and Forms pertaining to their area of focus, as needed
• Assists in the execution of efficiency improvement projects with guidance
• Ensures that products are manufactured, packaged, and tested according to applicable FDA guidelines, GXPs regulations and internal SOPs
• Participates in Quality programs, procedures and controls to ensure that products conform to established standards and agency guidelines
• Ensures gathering of data, investigations and deviations are timely and compliant
• Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines
• Respond and interact with internal and external clients in a professional and timely manner
• All other duties as assigned

III. 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
• Recognizes 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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