What are the responsibilities and job description for the QA Specialist GMP position at Actalent?
Description:
• Working cross-functionally with teams to provide change management guidance
• Responsible for gathering site metrics including providing annual APQR change control data
• Work with Sr. Manager of Change Management with providing site training
• Draft and review site change management guidance documents and work practices
• Administrate scheduled and ad-hoc change management governance meetings including scheduling, building agenda, and issuing meeting minutes
• Facilitate the closure of change control records within the quality management system
• Perform ad hoc duties as required in support of all of the Quality Systems at the Jump site including, but not limited to the following:
o Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit.
o Identify and implement continuous improvement opportunities for Quality Systems
o Facilitate cross-functional team meetings
o Process, author, and review QMS (Quality Management System) documents in the electronic document management system
• Provide communication on the status of deliverables to customers, management and stakeholders.
Additional Skills & Qualifications:
• A minimum of three (3) years’ experience in a change management related role, preferably within a Quality Systems team
• Experience in quality management system (change management, deviation, CAPA, and risk management) processes is preferred
• Strong technical writing skill set and able to critically review documents while effectively inputting and expressing Quality principles.
• Innovative, proactive, and resourceful; committed to quality and continuous improvement.
• Ability to work effectively at a fast pace with cross-functional departments to finalize time-sensitive deliverables.
• Strong knowledge of cGMPs and regulatory requirements
• Must be able to self-direct, multi-task, and clearly communicate to the manager of decisions outside of established processes and the ability to build a cross functional network.
Experience Level:
Intermediate Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $25 - $35
