New

Lead Investigator

ALMAC Group
life insurance, 401(k)
United States, North Carolina, Durham
4238 Technology Drive (Show on map)
Sep 15, 2025
Almac Group is currently seeking a Lead Investigator for our Durham, NC location. The role of the 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 include but are not limited to: Conduct investigations into reported incidents in order to: Assess the impact Identify immediate actions to be taken to limit the issue Perform trending to identify if there are recurring issues Establish the cause(s) and contributory factors using appropriate Root Cause Analysis tools Identify appropriate CAPA to prevent recurrence Document investigations in a timely manner ensuring the utilization of the authorized tools and systems as appropriate. Make certain details are captured in a succinct and logical manner that will allow for the investigation to be easily understood by approvers, customers and/or regulators. Perform the role of the LI for incidents to which you have been assigned, in doing so: Visit the area (GEMBA) where the incident has been detected, when applicable Interview all involved in the incident/issue at hand Obtaining background knowledge to gain a full understanding of the process Document the findings in accordance with the principles of GMP and internal SOPs Provide regular updates to department managers and escalate identified regional or global trends. Participate in customer teleconferences to discuss details around particular incidents and provide updates should explanations or revisions required. Liaise with appropriate personnel to collate relevant information promoting a culture that encourages individuals to be forthcoming with information without fear of blame. Escalate to appropriate Departmental and Quality Management of any critical issues that become apparent during the investigation that may not have been immediately obvious. Proactively monitor the progress of all investigations assigned to you, taking ownership to ensure these are closed out in a timely manner. Where delays are encountered, escalate to Line Manager and Quality as applicable. Complete CAPA effectiveness checks assigned in a timely manner and document necessary evidence as required. Where effectiveness is not confirmed, escalate to Line Manager and Quality to consider appropriate actions necessary to resolve the issue. Promote good inter-departmental and global relationships. Work within and across functional groups and sites as necessary to ensure global consideration of investigations and the associated CAPA have been agreed. Attend periodic meetings with other LIs. Be actively engaged and forthcoming with ideas/experiences to ensure learning and continuous improvement is shared. Be forthcoming with suggestions regarding process improvement initiatives and contribute to discussions during Risk Assessments and SOP generation. Qualifications: Required Experience / Education: High School Diploma (or GED) with 4 years relevant pharmaceutical experience OR Associate's degree with 2 years relevant pharmaceutical experience OR Bachelor's Degree with1 year relevant pharmaceutical experience 1 year Industry experience within a pharmaceutical or relevant regulated, healthcare environment Preferred Experience / Education: Bachelor of Science Degree Experience within a role involving incident investigation, data analysis and narrative report compilation Technical writing experience Knowledge of root cause analysis techniques What can Almac Group offer you? Medical, Vision & Dental benefits from the 1^st of the month following start date 20 days PTO per year, accrued monthly following start date 12 holidays per year as well as one day for Annual Diversity Day Company paid Long and Short-term disability along with Life Insurance 401k company contribution 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 over 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. Embracing diversity is at the heart of enhancing Almac Group's unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally. 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/CV's 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.