STAQ Pharma is currently hiring a senior quality investigator for our Denver facility
$90-110K/year
The role is responsible for leading the deviation, investigation, and CAPA processes, investigating and closing deviations, identifying trends and recurrent deviations, working, and communicating cross-functionally with other departments to ensure investigations are thorough and efficient, and support Quality department in various tasks. The role also requires taking command in ensuring there is knowledge across the company on the metrics mentioned, and the necessary steps to create a Right First Time (RFT) Culture.
• Indpendently lead, investigate, and oversee the deviation, investigation process to closure.
• Identify the underlying causes of deviations by utilizing root cause analysis tools such as Control Charts, Fishbone Diagrams, 6Ms, and 5 Whys, etc.
• Develop and implement robust Corrective and Preventive Actions (CAPAs) to prevent recurrence of deviations.
• Monitor deviation metrics to assess trends and drive continuous improvement initiatives.
• Actively manage deviations to achieve RFT and on-time phase completion.
• Facilitate weekly/daily management reviews of deviation data.
• Create and educate on proactive preventative measures for deviations.
• Collaborate with cross-functional teams to address deviations promptly and effectively.
• Review and approve change controls related to deviations.
• Review, change, and approve SOPs and other GMP documents as needed.
• Act as the SME and Trainer for the Investigation/CAPA QMS module.
• Participate actively in internal and external audits as a SME for deviations.
• And execute other duties/tasks as assigned.
• Bachelor’s degree in Engineering, Chemistry, Biology, or related scientific discipline. Advanced degree preferred.
• Minimum of 8-10 years of experience in pharmaceutical manufacturing, quality management systems, conducting investigations, enacting root cause analysis regarding deviations, and supporting QMS processes.
• Experience with electronic quality management systems (MasterControl).
| • Advanced Knowledge of cGMP regulations, preferably related to pharmaceutical manufacturing. • Strong capability to conduct thorough root cause analysis and applying structured problem-solving techniques. • Leadership and organization, resolving conflict and meeting deadlines. • Excellent verbal and written communication skills. • Ability to work collaboratively to accomplish deadlines and objectives. • Ability to write procedures and reports clearly and accurately. • Ability to be proactive and adaptable to changing priorities. • Ability to prioritize tasks and manage multiple projects simultaneously in a dynamic environment. • Ability to mentor and train other team members to achieve proficiency. • Strong critical thinking and problem-solving skills to address complex issues and challenges. • Proficiency with Microsoft Applications, including MS Word, Excel, and Teams. |
