ALMAC Group
Almac Group is currently seeking a Lead Investigator for our Souderton, PA location.
The role of the PA Lead Investigator is integral to the success of the Pharmaceutical Quality Management System in ensuring that deviations and complaints (QEs) and resultant corrective actions and preventative actions (CAPAs) are initiated, investigated, documented and closed out in a timely fashion to prevent recurrence and to ensure customer satisfaction. The investigation process will involve impact assessment and evaluation of risk.
Responsibilities
Conduct investigations into reported incidents: assess impact, identify immediate actions, trend recurring issues, establish root cause using appropriate root cause analysis tools, and identify suitable CAPAs. Document investigations in a timely manner, ensuring the utilization of authorized tools and systems; capture details succinctly for approvers, customers, and regulators. Qualifications
Required High School Diploma (or GED) plus 4 years relevant pharmaceutical experience OR Associates Degree plus 2 years pharmaceutical experience OR Bachelor’s Degree 2 years of industry experience within a pharmaceutical or relevant regulated/healthcare environment Preferred Associate or Bachelor Degree Experience in incident investigation, data analysis, and narrative report compilation Technical writing experience Knowledge of root cause analysis techniques What Almac Group can offer YOU!
Full medical, vision & dental benefits the 1st of the month after start date 20 days of PTO plus 12 holidays per year Company paid long and short term disability along with life insurance 401k company match Professional development programs & continuous learning opportunities Want to see our latest job opportunities? Follow us on LinkedIn. Almac is an exceptional, award-winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years, now employing almost 7,500 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. “Partnering to Advance Human Health” is more than just a tagline – it is our way of life. RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CVs not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation. Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions. EEO is the Law EEO is the Law GINA Supplement Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.
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Conduct investigations into reported incidents: assess impact, identify immediate actions, trend recurring issues, establish root cause using appropriate root cause analysis tools, and identify suitable CAPAs. Document investigations in a timely manner, ensuring the utilization of authorized tools and systems; capture details succinctly for approvers, customers, and regulators. Qualifications
Required High School Diploma (or GED) plus 4 years relevant pharmaceutical experience OR Associates Degree plus 2 years pharmaceutical experience OR Bachelor’s Degree 2 years of industry experience within a pharmaceutical or relevant regulated/healthcare environment Preferred Associate or Bachelor Degree Experience in incident investigation, data analysis, and narrative report compilation Technical writing experience Knowledge of root cause analysis techniques What Almac Group can offer YOU!
Full medical, vision & dental benefits the 1st of the month after start date 20 days of PTO plus 12 holidays per year Company paid long and short term disability along with life insurance 401k company match Professional development programs & continuous learning opportunities Want to see our latest job opportunities? Follow us on LinkedIn. Almac is an exceptional, award-winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years, now employing almost 7,500 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. “Partnering to Advance Human Health” is more than just a tagline – it is our way of life. RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CVs not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation. Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions. EEO is the Law EEO is the Law GINA Supplement Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.
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