Clinical Quality Assurance Specialist - GCP, audit plans in Bedminster Township, NJ at Apex Life Sciences

Date Posted: 9/19/2018

Job Snapshot

Job Description


This position will be responsible for the oversight and the conduct of audits as they relate to Good Clinical Practice (GCP) and Good Laboratory Practices (GLP), to ensure compliance of Specialty Brands clinical trials with all established regulatory guidelines as well as company policies and procedures. The position currently reports to the Vice President Quality, ARD.

ESSENTIAL FUNCTIONS:

  • Develop Quality Assurance Plans for assigned Clinical Programs/Projects; Understand the phases, processes and techniques used to execute a Quality Assurance Plan
  • Represent GCQ in assigned Project Team Meetings.
  • Manage and perform audits of Investigational sites, as well as, assessments/qualification of vendors (such as Contract Research Organizations (CRO), Specialty Vendors, Laboratories for Non-Clinical (GLP), including associated documents, according to plan.
  • Perform audits of Investigator Brochures, Study Reports, Clinical Investigational Sites, and Study/Trial Master Files to assure compliance with study procedures, GCP, and regulatory standards.
  • Communicate audit outcome with applicable Clinical Operations team member(s) to include request for additional information for clarification, secure incomplete data items and resolution of discrepancies.
  • Effectively and accurately document audit findings by generating an audit report, or other Quality Assurance summaries and obtain responses in a timely fashion.
  • Follow-up on all open audits until closure.
  • Evaluate audit responses for compliance with applicable guidelines, regulations, and Standard Operating Procedures/Policies.
  • Discuss remediation when responses are unacceptable with manager. Execute the remediation plan as applicable.
  • Follow up on corrective and preventive actions to ensure continuing effectiveness.
  • Create and maintains audit files for GCQ.
  • Review clinical trials data for consistency, and completeness. Communicate and discuss findings with manager to ensure accuracy.
  • Provide QA Review of Regulatory documents being submitted to Regulatory Authorities to ensure compliance to the standards of Good Documentation Practices (GDP), GCP and applicable regulations.
  • Provide departments with industry updates, by use of internet, publications, references, etc.
  • Assist with hosting regulatory agency inspections (e.g. Runner, Scribe).
  • Capable of contributing to effective SOPs, Checklists, Templates, Quality Assurance Reports and training materials.


REQUIREMENTS:

  • Bachelor degree required.
  • 5+ years pharmaceutical clinical research, monitoring, medical writing and/or data management experience.
  • Clinical QA auditing experience, GCP/GLP auditing experience is desired
  • Sound awareness and understanding of the pharmaceutical business, especially with regard to the Quality, Compliance and regulatory requirements of clinical development
  • Demonstrated proficiency within ICH GCP E6/8 (Good Clinical Practices (GCPs)), 21 CRF, Good Laboratory Practices (GLP), quality systems (SOPs) and audit procedures.
  • o Familiarity with current and pending FDA regulations.
  • Knowledge of other Regulatory Authorities regulations are a plus (e.g. EMEA, MHRA, TGA, etc.) Knowledge of Good Manufacturing Practices (GMP), Good Pharmacovigilance (GPvP), EU Directives, Health Canada or other non-USA Regulations, is a plus
  • Thorough understanding of clinical practices ( Clinical Trial Phases (Phase I, II, II and IV))
  • Possesses the necessary science education and knowledge to manage related clinical trials and to assure ethical treatment of subjects.
  • Understands medical terminology and is familiar with standards of care and disease states.
  • Has some knowledge of applying principals of 21 CFR Part 11 to clinical systems.
  • Must be able to manage and coordinate all tasks assigned and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
  • Good organizational skills
  • Must be able to prioritize work effectively to meet timelines.
  • Proficient computer skills
  • Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members.
  • Good mathematical and analytical skills.
  • Attention to detail.


EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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