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 include but are not limited to:
The role of the Lead Investigator is to conduct investigations into reported incidents in order 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.
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 Industry experience within a pharmaceutical or relevant regulated / healthcare environment
Preferred:
- Associate or Bachelor Degree
- Experience within a role involving 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 to start 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
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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/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.
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.
UK 
Fri, 21 Nov 2025 00:00:00 GMT