Quality Assurance Specialist job in Boston, USA

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Last Name*

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Job type: Permanent

Discipline: Good Clinical Practice (GCP), Good Laboratory Practice (GLP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in Boston, MA.

Job Responsibilities:

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.

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