Associate - QA Batch Disposition

Job Responsibilities

• Assures patients worldwide of safe and efficacious drug and device products through effective quality oversight of site activities.
• Final disposition of Semi-Finished and/or Finished drug combination products.
• Essential for ensuring GMP compliance in the qualification, validation, control strategy, and startup of operations to ensure regulatory approval of the facility.
• Supports the site in the development and execution of the site readiness plan with focus on supporting development of the site e-release process and startup of new systems.
• Performs final batch disposition of semi-finished and/or finished drug product and combination product batches to ensure high quality medicine (GMP Compliance) is released to market in a timely manner.
• Effectively owns/reviews/approves GMP documents to ensure quality attributes are met (i.e.: Deviations, procedures, protocols, specifications, and change controls).

Basic Requirements

• Bachelor’s degree in STEM
• Experience working in the pharmaceutical or medical device industry in QA roles
• Batch disposition experience
• Technical decision-making and guidance abilities
• Proficiency with applicable computer systems
• Strong oral and written communication skills
• Interpersonal skills and teamwork ability
• Root cause analysis/troubleshooting skills
• Demonstrated attention to detail and quality system maintenance
• Regulatory inspection readiness and execution experience
• Ability to work 8-hour days – Wednesday through Sunday Day Shift (not eligible for remote work)
• Ability to work overtime and be on-call as required
• Proven ability to work independently or as part of a Team to resolve issues
• Previous experience with Event and Change Management process
• Proficiency with SAP, MES, and Trackwise
• Previous experience with device and parenteral product materials

Additional Skills/Preferences

• Ability to work 8-hour days – Wednesday through Sunday Day Shift (not eligible for remote work)
• Ability to work overtime and be on-call as required
• Proven ability to work independently or as part of a Team to resolve an issue
• Previous experience with Event and Change Management process
• Proficiency with SAP, MES, and Trackwise
• Previous experience with device and parenteral product materials