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Quality Assurance Analyst (GCP Experience Required)

The Quality Assurance Analyst ensures that all study work is conducted to Bracket’s procedures and processes and supports the Bracket Quality Management System. The goal of the Quality Assurance Analyst is to foster and promotes a culture of quality throughout the Company.

Essential Duties and Responsibilities:

Note:  Other duties may be assigned.

Ensuring QA compliance with regards to ICH/FDA, GCP, SOPs, EU directives and national/local guidelines
Providing GCP/QA consultation for company staff
The review of company QMS Documents
Review and approve project workflow tickets for project lifecycle promotion (approximately 50%)
Reviews validation documents for adequacy and adherence to Bracket SOPs.
Collaborates with other departments to ensure validation activities are executed in a compliant fashion.
Applies risk-based principles for computer systems compliance issues in alignment with Bracket policies and standards.
Provides support for other compliance- and validation-related initiatives.
Create and maintain employee training documentation and records
Coordinate and schedule new-hire training and prepare training material
Assist in the development and presentation of training material
Monitor track and report overdue items in QMS system
Assist with controlling QMS and project-related documentation and records
Provide support in planning, executing and report internal audits
Provide support in planning, executing and report supplier audits
Perform Project Archiving QA reviews
Aid in audits and audit support.
Coordinate project planning, execution, monitoring and reporting
Other project work and responsibilities as required.

Education and Experience 

Bachelor’s degree or commensurate experience

At least a year of work experience involving supporting multiple projects/processes in a fast-paced work environment.

High degree of self-motivation and attention to detail.
Superior verbal/written communication and interpersonal skills including the ability to deliver information effectively and facilitate team processes in person and via telephone or e-mail.
Ability to work collaboratively and take direction from multiple inputs.
Ability to manage and meet multiple deadlines and respond to multiple requests for support.
Proficient computer skills including Word, Excel, Outlook and PowerPoint.  Familiarity with Visio preferred.
Ability to quickly learn and apply new skills, procedures and approaches.
Demonstrated ability to meet very short deadlines & multi-task in an extremely fast-paced work environment with little direct supervision.
Proven ability to work in a team-oriented environment, providing back-up support to team members & establishing/maintaining effective work relationships with co-workers within and across functional areas.
Previously demonstrated proactive and positive approach to tasks and projects overall, as well as to the types of scheduling & process changes that are inherent in a fast-paced business.

We offer a highly competitive base salary and an outstanding benefits program, including medical, prescription drug, dental, vision, 401(k) with Company match, life insurance, and generous paid time off.

We are an Equal Opportunity Employer, M/F/D/V

 

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