Quality Assurance Specialist (Remote) Details

Quality Assurance Specialist (Remote)

Alimentiv - Raleigh, NC

Employment Type : Full-Time

POSITION LOCATION: Canada, US, Germany, UK, Netherlands (Office or Home-based)

POSITION TITLE: Quality Assurance Specialist

POSITION REPORTS TO: Director, Quality Assurance

DEPARTMENT/UNIT NAME: Quality Assurance

JOB SUMMARY:

Alimentiv is looking for an IT focused Quality Assurance Specialist responsible for providing senior support in planning, organizing and conducting IT audits, assessments of IT vendors and providing day-to-day support of IT related global quality assurance (QA) services. The QA Specialist is also responsible for ongoing quality improvement through clinical audit and liaison with other business units and external partners and will also provide support, expertise, and industry best practice guidance to internal stakeholders.

AREAS OF RESPONSIBILITY:

Quality Assurance Implementation

• Implement quality assurance plans and processes and identify indicators needed to assess product/service quality levels.
• Conduct internal audits, site audits, vendor assessments and vendor audits in compliance with standards and regulation governing clinical research
• Perform audits of IT systems and validation processes in compliance with the requirements of ISO 27001 and 21 CFR Part 11
• Oversee the development of Quality System documents including policy, procedure, instruction, guidance and form and template development in collaboration with departments and senior management.
• Develop QA processes, train and oversee junior QA staff.
• Liaise with the Human Resources department to ensure that all staff are qualified.

Regulatory, Ethical Conduct and Audit Monitoring

• Remain current on and ensure internal awareness of regulatory trial conduct standards and requirements.
• Assist the management team by identifying and facilitating the implementation and/or the development of policy, processes, or training to meet these standards.
• Facilitate Sponsor and regulatory inspections and audit activities including preparation of staff, oversight of proceedings and ensure findings addressed are resolved.

Product/Service Consulting

• Provide guidance during product/service enhancements cycles or during times of organizational change around quality compliance and cross-functional process requirements and organization efficiency gains.

QUALIFICATIONS:

Applicants must have a degree, preferably in a Computer Science or Life Science field, along with 7-9 years of relevant experience. The successful candidate must possess direct expertise in performing IT audits and knowledge of ISO 27001 and 21 CFR Part 11 as well as a strong background in process improvement and establishment/maintenance of Standard Operating Procedures (SOPs). Experience and knowledge of Good Clinical Practice (GCP) is an asset. Must have excellent verbal and written communication skills along with an advanced level of attention to detail. Must also demonstrate strong interpersonal relationship, collaboration skills working within cross-functional teams and a passion for Quality. Successful candidates must exhibit enthusiasm, determination, and intuitiveness, and be organized and detail-oriented.

WORKING CONDITIONS:

Office/Home-based

• Accommodations for job applicants with disabilities are available upon request