Sr. Quality Assurance Specialist at Alimentiv – London, Texas
Alimentiv
London, Texas, 76854, United States
Posted on
NewSalary:$89000 - $148000Job Function:Admin/Clerical/Secretarial
New job! Apply early to increase your chances of getting hired.
About This Position
Sr. Quality Assurance Specialist
Regulatory, Ethics and Privacy Support
$89,000 - $148,000 a year
The Senior Quality Assurance Specialist is a senior technical expert in Quality Assurance, responsible for planning and execution of Quality Assurance deliverables, while overseeing and evaluating the technical aspects of the work performed by the department and providing technical mentoring to the Quality Assurance staff. This role requires advanced technical knowledge in regulations and industry standards in the conduct of clinical trial operations with a strong understanding of research ethics and privacy.
Quality Planning, Execution and Oversight - Develop, implement, and track compliance of QA plans (study, internal process and annual).
- Project manage department projects and deliverables to ensure work is of high quality, meets timeline commitments and is well communicated to other stakeholders.
- Monitor, evaluate quality indicators, QA reports and audit responses.
- Support study operational teams with resolution of escalated issues.
- Identify quality GCP risks and work with leaders to design mitigation strategies.
- Lead investigations, audits or QA related corporate initiatives and mentor other QA staff in the performance of these activities.
- Act as a senior representative of Quality at internal and external meetings.
- Support Sponsors, corporate and clinical operational teams with global quality, regulation, ethics, and privacy inquiries.
- Remain knowledgeable and current on industry environment and regulatory legislation.
- Mentor other QA staff in the support of the development of standard operating procedures.
- Serve as a technical role model, motivator, and mentor to the members of the quality team.
- Assist the Director with the development of departmental budget activities as the technical expert on audits and associated costs.
- Develop and provide training both within the department and external to it.
- Minimum of a bachelor's degree with 7-9 years of related experience and on the go training
- Fluent in English (verbal and written)
- Certification in Quality GCP or Auditing with strong written and verbal communication and presentation skills.
- Life Sciences, Clinical Research, Information Technology or Clinical Quality Assurance specialty preferred.
- Strong analytical, critical thinking and problem-solving skills required.
- Knowledge of ICH GCP, global regulations governing Clinical Research and global privacy regulations.
- Home-based
- *Accommodations for job applicants with disabilities are available
$89,000 - $148,000 a year
Scan to Apply
Just scan this QR code to apply from your phone.
Job Location
London, Texas, 76854, United States
Frequently asked questions about this position
Latest Job Openings in Texas
CDL-A - Regional Van Truckload truck driver - home weekly
Schneider
Fort Worth, TX
CDL-A - Dedicated Flatbed truck driver - PODS
Schneider
Dallas, TX
CDL-A - Intermodal truck driver
Schneider
Mesquite, TX
Dietary Assistant Cook
Oak Manor Inc
Schulenburg, TX
CDL-A - Intermodal truck driver
Schneider
Mesquite, TX
Continue to apply
Enter your email to continue. You’ll be redirected to the employer’s application.By clicking Continue, you understand and agree to JobTarget's Terms of Service and Privacy Policy.
Apply Now