Lead Quality Assurance Investigator

2 weeks ago

Denver, Colorado, United States Staqpharma Full time

STAQ Pharma is seeking a Lead Quality Assurance Investigator to join our team in a pivotal role.

The successful candidate will be responsible for steering the investigation of deviations, managing the Corrective and Preventive Action (CAPA) processes, and ensuring the timely resolution of quality issues. This position requires a collaborative approach, working closely with various departments to guarantee that investigations are comprehensive and effective.

The individual will play a crucial role in fostering a culture of Right First Time (RFT) across the organization by promoting awareness of key metrics and the steps necessary to achieve quality excellence.


Key Responsibilities:
  • Lead and manage the investigation process for deviations until resolution.
  • Utilize root cause analysis methodologies, including Control Charts, Fishbone Diagrams, 6Ms, and 5 Whys, to identify the root causes of deviations.
  • Design and implement effective Corrective and Preventive Actions (CAPAs) to mitigate future occurrences.
  • Analyze deviation metrics to identify trends and spearhead continuous improvement initiatives.
  • Ensure timely management of deviations to support RFT and on-time project completion.
  • Conduct regular reviews of deviation data with management.
  • Develop and deliver training on proactive measures to prevent deviations.
  • Collaborate with cross-functional teams to ensure prompt and effective resolution of deviations.
  • Review and approve change controls associated with deviations.
  • Revise and approve Standard Operating Procedures (SOPs) and other Good Manufacturing Practice (GMP) documents as necessary.
  • Serve as the Subject Matter Expert (SME) and Trainer for the Investigation/CAPA Quality Management System (QMS) module.
  • Actively participate in internal and external audits as a SME for deviations.
  • Perform additional duties as assigned.

Minimum Qualifications:
  • Bachelor's degree in Engineering, Chemistry, Biology, or a related scientific field; an advanced degree is preferred.
  • A minimum of 8-10 years of experience in pharmaceutical manufacturing, quality management systems, conducting investigations, and implementing root cause analysis related to deviations.
  • Familiarity with electronic quality management systems, specifically MasterControl.

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