This job board retrieves part of its jobs from: Toronto Jobs | Emplois Montréal | IT Jobs Canada

Fresh job offers in the Sunshine State!

To post a job, login or create an account |  Post a Job

Senior Quality Auditor

4G Clinical

This is a Contract position in Tallahassee, FL posted October 10, 2021.

Description In addition to Wellesley, MA, we welcome candidates in Raleigh-Durham, NC.

Fast Company recently announced its 2020 Best Workplaces for Innovators list, honoring businesses and organizations that demonstrate a deep commitment to encouraging innovation at all levels.

4G Clinical came in at 8 for its dedication to building a culture that fuels innovation, curiosity and the spirit of experimentation in all facets of the business from product development and brand to services and staffing.

We were also voted one of the 2018 Best Places in Health Care & Biopharma by Great Place to Work® and FORTUNE .

4G Clinical is a global leader in randomization and trial supply management (RTSM) and supply forecasting optimization software for the life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solutions utilizing natural language processing (NLP) to accelerate clinical trials.

4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia Job Requirements: RESPONSIBILITIES Responsibilities of the Senior Quality Auditor include: Planning, conducting and reporting of internal audits assigned per the quarterly audit schedule or requested by Quality Audit Lead or Quality Management.

Conduct internal audits of all corporate products and areas related to 4G’s product and services offerings, including but not limited to: Product Development life cycle, Study Development life cycle, Training, Client Studies, Data audits, product releases, change control.

Provide guidance for issue resolution as applicable, and work with Computer Systems Validation (CSV) group to ensure resolutions include maintaining the validation of products and studies.

Conduct lessons learned with auditees, as appropriate, after audit completion.

Audit to regulations, procedures, and industry best practices.

Prepare audit reports and certificates.

Provide mentoring to junior auditors.

Participate in continuous improvement of 4G Clinical procedures and overall quality system.

Monitor and analyze results of internal audits for trends.

Work with the Quality Audit Lead for audit reporting and escalations to Quality Management.

Assist in hosting client audits and participate in all regulatory inspections.

REQUIRED EXPERIENCE The position requires a minimum of 5 years of experience as an auditor in a regulatory environment.

Three years of auditing experience of Computer Systems Validation and RTSM experience is desired.

Skills in audit planning, audit conduct, and audit management are essential.

EDUCATION AND/OR CERTIFICATION REQUIREMENTS The candidate must possess a bachelor’s degree in a life sciences or information technology field, or equivalent auditing experience.

OTHER SKILLS/REQUIREMENTS Membership in professional organizations such as the Society of Quality Assurance (SQA), or Regulatory Affairs Professionals (RAPS) certification are desired This position does not have direct management of people responsibilities.