Quality Assurance Specialist
Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in Boston, MA.
- Assist in the development, implementation, and maintenance of GCP Quality Systems and SOPs
- Participate in the execution of GCP QA strategies for the support of global clinical trials.
- Provide support for internal and external audits related to studies, systems, documents and functions
- Support conduct of audits, mock inspections and health authority inspections
- Assist with preparations for GCP/PV inspections for corporate as well as CROs and investigator sites
- Provide administrative support to the GCP QA representatives on clinical teams to ensure compliant execution of clinical studies
- Assist with establishing metrics and reporting the state of GCP Quality and compliance of clinical trials to senior management
- Ensure Clinical Development activities are compliant with GCP, GLP, FDA, ICH, EMA regulations and guidelines and industry standards
- Participates in departmental compliance projects and process improvement initiatives, as requested
Skills and Requirements:
- Minimum of 3 years of relevant experience in a biotech/pharmaceutical or healthcare setting, preferably with GCP Quality Assurance experience
- Excellent interpersonal, organizational, verbal, and written communication skills, with the ability to work in a team environment
- Working knowledge of relevant FDA, EU, ICH GCP guidelines and regulations
- Excellent attention to detail, time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines
- Experience in supporting Regulatory Authority GCP/PV Inspections
- Continue to develop experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including applicable GxP auditing
- Has led or supported document review (source data verification) initiatives for example: DSUR, IB, NDA, CSR, etc., deploying both internal and external resources
If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.