Staqpharma
Senior Quality Investigator
Staqpharma, Denver, Colorado, United States, 80285
STAQ Pharma is currently hiring a senior quality investigator for our Denver facility.$90-110K/yearThe 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 supporting the 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.Responsibilities:
Independently 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.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.Execute other duties/tasks as assigned.Minimum Requirements:
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, and enacting root cause analysis regarding deviations, and supporting QMS processes.Experience with electronic quality management systems (MasterControl).
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Independently 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.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.Execute other duties/tasks as assigned.Minimum Requirements:
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, and enacting root cause analysis regarding deviations, and supporting QMS processes.Experience with electronic quality management systems (MasterControl).
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