Deviation Investigator
Job in
Clayton, Granville County, North Carolina, 27528, USA
Listed on 2026-09-14
Listing for:
Actalent
Full Time
position Listed on 2026-09-14
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, Production QC/QA -
Manufacturing / Production
Regulatory Compliance Specialist, Quality Engineering, Production QC/QA
Job Description & How to Apply Below
Job Title:
Deviation Investigator
Job Description
The Deviation Investigator supports people, equipment, and processes in operational areas to ensure business objectives and regulatory requirements are consistently met. This role collaborates closely with cross-functional stakeholders, particularly production and quality assurance, to investigate deviations, implement quick containment actions, and drive effective root cause analysis. The position offers hands-on exposure to pharmaceutical manufacturing investigations and provides an excellent opportunity to develop expertise in a highly regulated, global environment.
Responsibilities
+ Work directly with production and quality assurance teams to investigate deviations, implement quick containment actions, and perform thorough root cause analyses.
+ Ensure processes and activities comply with internal standards, procedures, and applicable regulatory requirements.
+ Identify process needs and improvement opportunities for routine to minimally complex issues, and support implementation of corrective and preventive actions.
+ Perform process confirmations to verify adherence to procedures and to sustain process improvements over time.
+ Review batch production records (BPRs) as necessary to support investigations and ensure documentation accuracy and completeness.
+ Apply systematic problem-solving methods to analyze issues, document findings, and recommend effective solutions.
+ Support CAPA (Corrective and Preventive Action) activities related to deviations and process improvements.
+ Collaborate with cross-functional teams in production, quality, and other support functions to ensure timely resolution of deviations.
+ Follow all safety and environmental requirements while performing duties in office and production areas.
+ Maintain clear, accurate, and compliant written documentation related to investigations and process changes.
+ Perform other related duties as assigned to support operational and quality objectives.
Essential Skills
+ Associate's degree in technology, engineering, or a related technical field from an accredited institution, or a High School Diploma or equivalent with a minimum of two (2) years of manufacturing experience, preferably in a pharmaceutical manufacturing environment.
+ Minimum of one (1) year of manufacturing experience in a pharmaceutical manufacturing environment preferred.
+
Experience with deviation investigation or quality assurance activities.
+ Strong systematic problem-solving skills, including the ability to perform structured root cause analysis.
+
Experience with CAPA (Corrective and Preventive Action) processes and methodologies.
+ Pharmaceutical manufacturing experience, including familiarity with regulated production environments.
+ Excellent written communication skills, with the ability to produce clear, concise, and compliant technical documentation.
+ Knowledge of Good Manufacturing Practices (GMP) preferred.
+ Familiarity with quality or manufacturing systems and tools preferred.
+ Prior manufacturing experience, ideally in a highly regulated environment.
Additional
Skills & Qualifications
+ A background in engineering, technology, or a related technical field is strongly preferred.
+ Pharmaceutical manufacturing experience is a plus and will support success in deviation investigations and process improvements.
+ Exposure to environmental monitoring, aseptic operations, and compliance activities is beneficial.
+ Experience in technical writing, particularly for investigations, reports, and CAPA documentation, is highly valued.
+ Ability to collaborate effectively in cross-functional teams spanning office and production environments.
+ Strong attention to detail and a commitment to maintaining high quality and compliance standards.
+ Motivation to grow within a global pharmaceutical organization and gain deeper expertise in investigations and quality systems.
Work Environment
This is an on-site role with a standard schedule of Monday through Friday, typically from 8:00 a.m. to 5:00 p.m. The position operates in a cross-functional setting, with time spent in an open office environment that may include frequent distractions, as well as on the production floor in partnership with manufacturing teams. The role involves working within a regulated pharmaceutical manufacturing environment that follows strict safety, environmental, and GMP requirements.
The Deviation Investigator will engage with modern quality and manufacturing systems and collaborate…
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×