Assist in the management of Good Clinical Practice (GCP) activities in the support of studies and projects across one or more clinical programs.
Responsibilities
Assist in the management of Good Clinical Practice (GCP) activities in the support of studies and projects across one or more clinical programs.
Assist and coordinate review and tracking of clinical investigator site or internal system/process audit responses and associated tasks across therapeutic areas.
Interact with Clinical Audit, Quality Assurance, and Operations teams and supporting functions to ensure quality compliance.
Escalate potential quality issues to management.
Support review of clinical audit responses for adequacy, consistency and compliance.
Requirements
Bachelor's Degree in a physical science, life science, nursing, pharmacy, or equivalent experience desired.
Seasoned individual contributor within the Supply Chain Technology function, Quality sub-function, accountable for the support, enhancement, and AI-enabled modernization of the enterprise quality systems landscape at DePuy Synthes.
As an IT Engineer, you will provide technical and operational support across end-user systems, infrastructure, and business applications. You will ensure stable, secure, and compliant IT operations aligned with Thermo Fisher Scientific’s global standards.
Responsibilities
Serve as an IT support representative for Brisbane sites for all site IT-related services which include End User Support, Infrastructure Support and Business Applications.
Serve as the interface between global IT and business units to ensure collaboration and coordination between all stakeholders and implement global IT computing solution standards to the sites.
Support employees with software and hardware issues e.g. Microsoft Office, printers, mobile and other end users computing (EUC) business applications and diagnose PC / Hardware faults and its solutions as required.
Ensure systems are equipped with software for backups and cyber security to ensure data is backed up, systems are secure, protected and patched per company standards.
Perform procurement of computers and peripherals and oversee system life-cycle management at the sites to ensure systems are replaced or upgraded in a timely manner to ensure continuous system stability and support.
Requirements
Diploma or bachelor’s degree in information technology or computer science, or equivalent
Nice to have: IT Site Support (desk side) in manufacturing or regulated environments (pharma, banking, logistics)
Responsible for the quality review, disposition, and release of commercial products marketed in the United States.
Compensation
The target base salary range for this role is $84,800-$106,000 per year. This range reflects the anticipated compensation for the role. Where pay falls withing the range may vary based on many factors, including, but not limited to, job responsibilities, skills, experience, education, certifications, location and applicable geographic pay zones, market conditions, internal equity and business considerations. Compensation decisions are made based on an assessment of the candidate’s qualifications and the totality of relevant factors. In addition to base salary, this role is eligible to participate in an annual short-term incentive program, subject to plan terms and eligibility requirements.
Responsibilities
Perform quality review and approval of commercial product release packages for Rx, OTC, and Cosmetics products.
Ensure all release documentation is complete, accurate, and compliant with applicable regulatory requirements, internal procedures, and quality standards.
Review manufacturing, packaging, testing, and disposition records provided by contract manufacturing organizations and contract laboratories.
Evaluate deviations, investigations, change controls, CAPAs, and other quality events for potential impact on product disposition decisions.
Conduct risk-based assessments to support product release decisions and ensure products meet established quality requirements.
Quality Manager responsible for guiding quality initiatives, supporting continuous improvement, and cultivating a culture of compliance and operational excellence across Thermo Fisher Scientific’s products and services.
Compensation
The salary range estimated for this position based in New Jersey is $113,600.00–$170,300.00.
Responsibilities
Strategically plan and prioritize Annual Product Quality Reviews (APRs) to meet assigned timelines.
Coordinate and compile management review presentations with subject matter experts.
Author and manage reports, decisions, and action items arising from APQRs and management reviews.
Support site Change controls, CAPAs and Deviations as needed.
Support site Quality Plan and track KPIs & metrics with applicable stakeholders.
Requirements
Bachelor's Degree plus 4-5 years of experience in quality experience in pharmaceutical, medical device or regulated industry
Analyze customer complaints to determine regulatory reportability and coordinate activities with internal, field, and end use customers while maintaining compliance with GMPs and regulatory requirements.
Compensation
Minimum Salary: $ 51000
Maximum Salary: $ 96900
Responsibilities
Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
Participate in development and modification of decision models with changes in product advances/therapies.
Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models.
Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
Responsible for investigating, documenting, and resolving manufacturing deviations in a sterile pharmaceutical environment.
Responsibilities
Author and support deviation investigations associated with sterile pharmaceutical manufacturing operations within Building 16
Develop clear, accurate, and comprehensive investigation reports that document the sequence of events, investigation findings, impact assessments, root cause analysis, corrective actions, and conclusions
Gather and evaluate information from manufacturing batch records, equipment logs, electronic systems, procedures, and other relevant documentation
Conduct interviews with manufacturing personnel and subject matter experts to establish factual event timelines and support investigation findings
Collaborate with cross-functional teams to identify potential contributing factors and determine appropriate investigation scope
Requirements
Associate's degree in a scientific, technical, engineering, or related discipline with 1 year relevant experience
Bachelor's degree in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or a related field preferred
The anticipated base pay range for this position is : $96,000.00 - $155,250.00
Responsibilities
Provides day-to-day technical support for enterprise quality systems
Supports and enhances validated quality platforms covering complaint handling, CAPA, nonconformance, deviations, change control, document management, training records, and audit management
Identifies, evaluates, and delivers AI and automation use cases across quality processes
Partners with Data Science and AI teams to define data requirements, validate model outputs, and operationalize AI-enabled capabilities within quality workflows
Ensures AI and automation solutions applied to quality systems meet GxP, 21 CFR Part 11, and data integrity (ALCOA+) expectations
Requirements
Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or a related discipline
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