Specialist, Sr Clin QA - 101043 - Marlborough, MA - 0300 Posted Date: August 22, 2013



Job Description

Sr Specialist, Clinical Quality Assurance
*position can be field based anywhere in the US
Purpose Statement:
Assists the Manager, Clinical QA, with internal quality assurance program for the assigned business area.  Serves as clinical QA representative on clinical project teams and conducts internal and external quality audits to assure that BSC clinical investigations comply with all applicable regulatory requirements and BSC policies and procedures.
 
Key Responsibilities:

·          Participates on clinical project teams.
·          Plans, schedules, and conducts internal and external quality assurance audits of the systems, procedures, and controls employed in the design, conduct, and analysis of clinical trials.
·          Serves as audit team lead.
·          Assesses sponsor/investigator/monitor compliance with protocol and GCP/ICH requirements.
·          Assesses the accuracy, validity, and quality of the scientific data generated during clinical trials.
·          Documents audit observations; evaluates impact, and makes recommendations for corrective actions.
·          Communicates observations to clinical investigators, clinical program managers, directors, and management.
·          Evaluates responses to audit findings and ensures that appropriate corrective actions are completed.
·          Participates in problem-solving at investigational sites.
·          Works cross-functionally in identifying and resolving technical issues.
·          Keeps abreast of and interprets current worldwide regulatory requirements; advises management on the possible ramifications of regulatory changes.
·          Supports departmental, functional, divisional, and corporate quality goals and priorities.
·          Updates the audit database.
·          Assists clinical QA Managers with annual audit planning, review and trending of audit results, and development and implementation of improvement initiatives.
·          Develops new audit procedures and processes.
·          Supports the preparation, coordination, and management of regulatory agency inspections of BSC offices.  During inspection, plays lead role as facilitator and communicator.
·          Prepares investigator sites for FDA or other regulatory agency inspections and assists in preparation of written responses to findings.
·          Provides training at investigator meetings. 
Quality System Requirements:

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Experience Required

Qualifications:- Bachelor's degree in Life Science or related field- Minimum 5 years experience in medical device or pharmaceutical industry in an arearegulated by GCP regulations and guidelines- 3 years clinical QA and/or compliance experience- 2 years auditing experience - Travel up to 50% can be expected