Morrisville, North carolina
Quality Assurance Specialist Job Opening in Morrisville, North carolina - Job Overview:
QMS Administrator with primary responsibility for the management of QMS documentation and training configuration and content held in Clinipace Worldwide?s EDM system, in compliance with Clinipace Worldwide SOPs. Responsible to work with and support Quality Services staff and Department Leaders to develop and maintain Clinipace?s QMS documents to ensure formatting and content consistency across all Departments. Manage MasterControl security and QMS administration, staff training configuration according to the approved Training Matrix and Clinipace Worldwide SOPs, to ensure appropriate access to Clinipace QMS documentation and related courses.. Support Quality Services in the development and deployment of training modules in MasterControl.
Assist QA auditor staff in the conduct of internal site, eTMF and other internal audits to assess and ensure compliance with Clinipace Worldwide SOPs. Work with QA auditor staff to maintain internal and external audit reports, Quality Event, CAPA and report completion of audit responses. Participate in sponsor and vendor audits to support successful outcomes.
Job Duties and Responsibilities:
Assist in the conduct of internal audits of the TMF including investigator file audits, project file audits as directed. Assist in other internal or external audits as in Sponsor audits and Vendor audits as necessary.
Assist in the management of Clinipace Worldwide's QMS documents. Revise, format, distribute and track necessary revisions in Master Control. Participate in QMS document review committees and QMS support. Provides MC training for new Employees and Contractors as required.
Configure and administer training courses, materials, exams and tasks in MasterControl. Periodically review training task compliance of Employees and Contractors in MasterControl and escalate non-compliance as needed to Department Leader(s).
Manage MasterControl security administration, including: roles, job codes, approval routes and organizers. Notify QMS Coordinators or Department Document Owners, of QMS documents coming due or past due for revision.
Manage tracking of audit schedule, training metrics, audit reports and files on all audits performed. Responsible for document control and archive of QA and audit files.
Job Requirements:
Education
BA/BS or combination of education and on the job training in Quality Assurance with essential documents and auditing.
Experience
6 months - 2 years with pharmaceutical / medical industry knowledge; understanding of quality assurance; document management/control is required; or equivalent on the job training.
Capabilities
Proficient in English grammar, spelling and format, with excellent attention to detail in proofing written content in compliance with Clinipace Worldwide SOPs.
Editing skills: Skillful at editing draft and revised documentation.
Organization knowledge and skills: Ability to develop and manage efficient information and workflow processes. Assist in tracking projects and meeting deadlines.
Implementation and coordination skills: Ability to proactively follow projects through to completion and assist teams in reaching goals. Demonstrates the ability to successfully coordinate multiple projects and tasks.
Communication skills: Demonstrates excellent verbal, written and presentation skills. Ability to keep others informed and involved in an efficient and timely manner.
Training skills: Ability to work globally with Clinipace Worldwide staff in all regions; to promptly and clearly provide training direction, through provision of detailed guidance to users in written, verbal or presentation format.
Technical skills:
Extremely knowledgeable in Word, Excel and PowerPoint. Demonstrates comfort in evaluating and applying new applications and technology. Assist in and manage Master Control administration and user support.
Facilitator: Demonstrates a record of working with others to find solutions, assure cooperation and make others? job easier. Has been a successful team member.
Quality process improvement: Demonstrated knowledge of process improvement and document management systems.
Skills/Competencies
Integrity: Demonstrates understanding of ethical behavior and has acted on principles of honesty, trust and fairness.
Helper: Excels in helping others, recognizing needs and solving problems.
Confident: Ability to work with minimal direction and use independent decision-making skills.
Positive workplace leadership: Demonstrates the ability to improve cooperation and communication at work.
Independent and proactive: Recognizes needs, conceives and executes solutions independently.
Flexible and innovative: Responds quickly with innovative solutions to changing needs.
Learning and developing: Consistently learns new skills and takes on increasing responsibility.
Efficient and timely: Consistently prioritizes to maximize the effectiveness of self and Executive Officer.
Job Type: Full-time
Required education:
Bachelor's
Required experience:
Quality Assurance: 2 years
Pharmaceutical / CRO: 2 years
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