Deviation Investigator
TriOptus LLC
Job Description:
Knowledge, Skills, and Abilities:
- This role will be responsible for the investigation of IT Enterprise related deviations to determine root cause and applicable corrective and preventive actions in accordance with FDA, MHRA, and other applicable global health authority regulations.
- Collaborate with IT and Quality resources to collect relevant information for deviation assessment and facilitate meetings with investigation teams.
- Manage deviation records and monitor completion of corrective actions within a Quality Management System.
- Investigate IT incidents with technical and business stakeholders to define if there is potential GxP impact and requirement to raise a quality deviation and subsequent investigation.
Knowledge, Skills, and Abilities:
- Thorough knowledge of and competence in IT processes, including but not limited to deviations, investigations, CAPA management, SLC, computer system validation, and change management.
- Must have strong knowledge and experience with cGMP, GCP, GLP Quality, and Compliance.
- Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
- Must be able to note technical attributes in potential situations or issues and process IT-based solutions across most of the job function.
- Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.
- Must provide guidance to other employees in the interpretation of technical issues across an interdisciplinary teams.
- Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, resource allocation, coaching other and analytical thinking.
- Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
- Work is self-directed.
- Confident in making decisions for minor issues.
- Routinely recognizes Quality issues and solves problems.
- Proposes solutions for complex issues and works with management to resolve.
- Follows established procedures and performs work as assigned.
- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
- Ability to interpret results and situations and articulate recommendations for resolution.
- Able to write and review reports with clarity and brevity.
- Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
- Excellent verbal and written communication skills.
- Advanced knowledge of complete MS Office suite.
- Firm understanding of technology platforms as needed for project.
- Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management; and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc)
- Excellent oral and written communication skills in English.
- B.S. degree required; advanced degree preferred.
- Minimum 5 years Quality Assurance and/or IT experience in a pharmaceutical company
- CAPA: 3 to 5 years
- CSV: 6 to 10 years
- Deviations: 6 to 10 years
- FDA Regulations: 6 to 10 years
- Investigations: 6 to 10 years
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Deviation Investigator in Princeton, NJ vacancy
- ...environments against threats. The role involves preventing, detecting, and mitigating cybersecurity issues, along with conducting investigations into cyber-attacks. Candidates should have a master's degree in Cybersecurity or a related field and at least one year of...SuggestedRemote workFlexible hours
Quantum Integrators Group
West Windsor, NJ3 days ago $120.3k - $222.6k
...financial results and its business ethics. Are you ready to make a difference?The PositionThe Senior Ethics and Compliance (E&C) Investigator will conduct investigations into ethics and compliance issues and remediate employee adherence to Novo Nordisk policies, federal...SuggestedLocal areaFlexible hoursNight shift- ...Novo Nordisk is seeking a Senior Ethics and Compliance Investigator to conduct internal investigations into ethics and compliance issues across the US operations. You will develop workplans, interview witnesses, and produce case files and reports for potential enforcement...Suggested
Initial Therapeutics, Inc.
Plainsboro, NJ3 days ago - ...Criminal Investigator (Special Agent)The Criminal Investigator (Special Agent), is responsible for planning, managing, conducting, and concluding (independently, jointly, or as a team leader) complex and sensitive criminal, civil, and administrative investigations and...SuggestedLocal area
US Department of Veterans Affairs
Trenton, NJ1 day ago - Announcement The Department of Veterans Affairs, Office of the Inspector General (OIG), is organized into six operational units with offices in more than 60 locations throughout the country. This is an announcement where applicants will be referred throughout the...SuggestedWork at office
US Government Jobs
Trenton, NJ2 days ago - Criminal InvestigationA description of the business units can be found at: are to be filled in the following area(s): CI - Criminal InvestigationConsider each location carefully when applying. If you are selected for a location, that location will become your official...
US Government Jobs
Trenton, NJ2 days ago - The Senior Ethics and Compliance Investigator at Novo Nordisk A/S in Plainsboro, NJ will conduct investigations into ethics and compliance issues and remediate adherence to company policies and laws. The Senior Investigator will identify and analyze ethics and compliance...
$65k - $88.6k
...Become a part of our caring community The Fraud and Waste Professional 2 conducts investigations of allegations of fraudulent and abusive practices. The Fraud and Waste Professional 2 work assignments are varied and frequently require interpretation and independent...Full timeTemporary workFor contractorsApprenticeshipWork at officeRemote workWork from homeHome officeMonday to FridayHumana
Trenton, NJ4 days ago$62.7k
...includes development and delivery of training and filing of Fraud Plans and Reports. The incumbent is responsible for conducting investigations of organizational or functional activities related to alleged fraud, waste and abuse perpetrated by providers, members,...Contract workFor contractorsWork at officeLocal areaHighmark Health
Trenton, NJ21 hours ago$68.5k - $102k
...successful career with opportunities to learn, grow, and make an impact. Join us! The Global Financial Crimes Compliance (GFCC) Investigator performs end‑to‑end investigations across one or more lines of business relevant to the investigator's specific area of responsibility...Work at officeShift workDay shiftBank of America
Pennington, NJ21 hours ago$24.04 - $31.25 per hour
...exploitation and unplanned lossParticipates in triage related to Executive Escalations & Incident Response fraud activitiesReviews and investigates reports of suspected fraudulent activity with accurate recording of data captured during client interactionsFollows established...Hourly payFull timeImmediate startDay shift- ...during mixing, before packing, HACCP).Support nonconformance investigations (Z3, Z1, Z5).Monitor overdue actions in the IMS and support document... ...analytical data, product specifications, and process changes/deviations before product release to ensure compliance with defined...Work at officeLocal area
System One Holdings, LLC
Princeton, NJ3 days ago - ...stability testing Review test data and logbooks, report any deviations to the Supervisor Ensure timely testing and result... ...customer audits, etc. Complete Out of Specification (OOS) Investigations, Non-conformance Investigations (NCs), Quality Investigations...Work at office
Integrated Resources
Plainsboro, NJ2 days ago $26 - $30 per hour
...during mixing, before packing, HACCP). Support nonconformance investigations (Z3, Z1, Z5). Monitor overdue actions in the IMS and... ...analytical data, product specifications, and process changes/deviations before product release to ensure compliance with defined specifications...Full timeContract workWork at officeLocal areaDay shiftSystem One
Princeton, NJ1 day ago$26 - $30 per hour
...mixing, before packing, HACCP). Support nonconformance investigations (Z3, Z1, Z5). Monitor overdue actions in the IMS and support... ...analytical data, product specifications, and process changes/deviations before product release to ensure compliance with defined...Contract workWork at officeLocal areaDay shiftSystem One Holdings, LLC
Princeton, NJ2 days ago- ...assist in the submission of protocol amendments, IND safety reports, consent form changes, and continuing reviews. Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings....
Connecting Talent 2 Opportunity
Princeton, NJ2 days ago - Job Description Job Description SORA Certification requires OPS Security Group is seeking a professional and reliable Loss Prevention Officer to provide security coverage at multiple client locations, including Cherry Hill, Marlton, and Princeton . This position...Daily paidFull timeFlexible hours
OPS Security Group
Princeton, NJ1 day ago $24 per hour
Mobile Per Diem Loss Prevention Officer- SORA certification requires- South & Central NJ Job Category: SECURITY SERVICES Requisition Number: MOBIL001501 Rate: $24 USD per hour (Part-Time) Locations 1558 Kings Hwy N, Cherry Hill, NJ 08034, USA 940 Route 73 N, Marlton...Hourly payDaily paidFull timePart timeFlexible hours- A prominent life sciences company is seeking an Executive Recruiter for a 12-month contract primarily remote, based in Princeton, NJ. The role involves supporting GxP document management initiatives, facilitating project plans, and providing audit support. Ideal candidates...Remote jobContract work
- About the DepartmentOur Marketing & Patient Solutions group creates and delivers human-centered experiences, where innovation meets customer-centricity, driving the ultimate experience for our patients. Our focus extends beyond transactions to craft experiences as one fully...Local areaFlexible hoursNight shift
- Company DescriptionAbout Client: They are an equal opportunity employer and with value diversity at their company. They do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability...
- Withum is a place where talent thrives - where who you are matters. It’s a place of endless opportunities for growth. A place where entrepreneurial energy plus inclusive teamwork equals exponential results.Explore different industries. Learn new skills. Connect with our...Full timeContract workWork at officeLocal area
$144.3k - $189.4k
...understanding.· Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups.· Establish, foster, cultivate and maintain peer relationships with...Full timeWork at officeWork from homeNight shift- Location: Plainsboro Township, New Jersey, United StatesCompany: Integra LifeSciencesPosted: 2026-08-19INTEGRA LIFESCIENCES CORP is seeking a Lead Auditor for Quality Compliance to oversee corporate audits across multiple facilities. The role demands extensive GMP auditing...
$162.32k - $243.48k
...launches through HCP education for safe use of our medicines Act as the primary point of contact and facilitator for all aspects of investigator sponsored trials (ISTs), from submission, review and approval, through study activation/completion Collaborate effectively and...Full timeFixed term contract$17.75 - $28.33 per hour
...continuously watching for and timely reporting of potential safety hazards and unusual occurrences through patrol of assigned areas. Investigates complaints or potential criminal conduct; assists in restraining patients as necessary; provides protective services. Possesses...Hourly payTemporary workPart timeShift workWeekend workPenn Medicine
Plainsboro, NJ2 days ago$90k - $157.5k
What we are looking forAs a Front-Office Developer will be an integral player of the Charles River implementation team. Senior Consultants brings technical expertise and direction to implementation teams, ensuring proper implementation of Charles River’s IMS suite at our...Full timeTemporary workRemote workFlexible hours- Pharmacovigilance (PV) Analytics and Reporting SpecialistJob Number: 25-03625 Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Pharmacovigilance Specialist for our client in Lawrenceville, NJ. ECLARO’s client is a leader...
- Contract Analyst The contract analyst will act as liaison between internal teams regarding implementation activities and the software development lifecycle. • Train users on web-based applications and system updates • Designs, develops, and delivers live, virtual...Contract work
Talium Advisors
Princeton, NJ2 days ago - Reliability Advisor Serve as a reliability advisor for high risk changes across the organization. Lead or oversee major enterprise-level change events (e.g., data center cutovers, platform migrations). Shape governance and guardrails for operationally safe change...
Diverse Lynx
Princeton, NJ21 hours ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Deviation Investigator. Be the first to apply!
