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Senior Quality Assurance Specialist - GCP


 Save this Job ID: 146009
Company Name: View All Cubist Jobs Approximate Salary: Not Specified  
Location: Lexington, Massachusetts Country: US
Industry: Quality Assurance Position type:Full-Time
Experience level: Education level:
Short Description
Other
Long Description
Position Summary: The Sr. QA Specialist assists in the development, implementation and management of Cubist R&D Quality Assurance programs and initiatives. Conducts internal and external audits to assess compliance with regulations and Cubist policies and procedures. Serves as Quality / GCP resource for clinical teams. Collaborates with Clinical Research / Clinical Operations personnel to ensure that clinical trials comply with SOPs, FDA regulations, and ICH/GCP guidelines.

Provides expert GCP compliance and general QA support; acts as liaison between product development teams and QA.

Plans, coordinates and conducts internal and external (domestic and international) GCP-related audits. Investigator Site Audits

System/Process Audits

Vendor Audits (CROs, Labs)

Data Audits

Trial Master File (TMF) Audits

Document Audits (protocol, ICF, IB)



Assists in the development and maintenance of quality management systems, from the GCP perspective.

Reviews SOPs to ensure compliance with applicable regulatory and corporate standards.

Participates in the development and delivery of internal training programs.

Assists management in the preparation for regulatory agency inspections.

Supports the preparation, coordination, and management of regulatory agency inspections of Cubist clinical research operations. During inspection, plays lead role as facilitator and communicator.

Supports 'for cause' audits, as necessary.

Keeps up to date with current regulatory guidelines and regulations.

Minimum Basic Qualifications: Bachelor s degree in a scientific discipline

5 years in a pharmaceutical quality assurance / compliance role

At least 3 years experience in an GCP auditing role, with one year as a lead auditor

Experience Required: Working knowledge of Code of Federal Regulations (CFR) and ICH Guidelines governing clinical research and familiarity with current initiatives

Knowledge of medical practice/techniques and terminology

Must be able to partner with a diverse group of staff/consultants with different strengths and skills Ability to prioritize work and handle multiple assignments, while maintaining quality

Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner

Ability to work independently and as part of a team, detail oriented Excellent communication skills and investigative techniques





Desired Competencies and Qualifications: Working knowledge of 21 CFR Part 11 and Computer System Validation (CSV)

Working knowledge of 21 CFR Part 58 and GLP auditing experience

Experience in international compliance / auditing

Experience in developing and writing SOPs

Auditor certification (ASQ, SQA)

Work Environment: This position will be based in the Lexington, MA office

Physical Demands: The candidate must be willing to travel (up to 50% during peak workloads)

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.



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