GCP Quality Auditor
Company: Promedica International
Position: GCP Quality Auditor
Location: Southern California
Posted: June 17, 2021
- Bachelors' Degree in Science, Quality Engineering, or related field.
- CRA Experience and/or site monitoring experience is required in order to be effective at this role. Candidate should have a working experience with TMF/eTMF and site documentation requirements.
- 2-3 years related clinical QA experience in the CRO, device, pharmaceutical, or biotech industry. Working knowledge of current GCP regulations, guidelines, and related auditing techniques.
- This position is mostly remote but NOT100% remote. Candidates are expected to live within a driving distance from the office and commute to the office at times of need.
- Plan and perform on-site and remote audits of clinical investigation site monitoring visits (i.e. CRA Audits) by looking at all regulatory files and various site documentation required as part of TMF.
- Plan and perform on-site and remote audits of clinical investigation sites and related operations and quality.
- Plan and perform internal audits of the Quality Management System (QMS) and Trial Master Files (TMF).
- Supports Quality System Manager in promoting and assessing compliance of contracted functions with regulations, guidelines and corporate policies and customer requirements
- Provides quality assurance support, under the direction of Quality System Manager or senior staff, of assigned projects through interaction and consultation with sponsors, site, project, and study teams.
- Conduct GCP, ISO and/or consultancy projects for customers, as applicable, according to departmental and/or customer policies and procedures, within budget and agreed timelines.
- Participate in CAPAs including root cause analysis and reviewing corrective actions, as required.
- Represent QA on sponsor/project teams, under the direction of Quality System Manager.
- Working knowledge of ISO 9001:2015
- Provide support during the hosting of sponsor audits and mock regulatory inspections. May host sponsor audits and work with responsible parties to prepare corrective action plan as applicable.
- Provide input to interpretation, support, and training for interpretation of regulations, guidelines, corporate standards and policies.
- Assists with and documents audits of Quality Assurance Policies in accordance with written audit plans to check for adherence to the Quality System.
- Assists with requested reviews of project-related and non-project-related work products to check for adherence to SOPs.
- Prepares regular written and oral status reports for Quality System Manager.
- Perform trend analysis of QMS data
- Conduct of job responsibilities in accordance with current regulations including, but not limited to FDA, ICH, and ISO.
- Periodically review SOPs against current regulations including, but not limited to FDA, ICH, and ISO.
- Perform other related duties as assigned.
- This position may involve approximately 25% travel and requires a person who works effectively with clinicians, clients, vendors, FDA Inspectors, and staff.