Job ID :
US - Alabama - Auburn
Under the direction of the Manager, Quality Assurance this position is responsible for managing Quality System documents and Document Change Requests while also ensuring their accuracy, quality and integrity. This role will help the organization adhere to record retention policies, DHR/Batch Record Review, safeguard information and control documentation.
ESSENTIAL DUTIES AND RESPONSIBILITIES
QMS document administration including: password setup, general training and usage questions.
Control, formatting, and editing of all Quality System documents and templates.
Processing and follow-through with the approvals and tracking of documents.
Use and follow the approval matrix for document revisions/updates.
Escalate if documents are not reviewed, approved, and trained in a timely manner.
Communicate the release of new and updated documents.
Routine maintenance of active and archived controlled documents and records in accordance with department SOPs
Follow up on Training of documents to ensure completed and maintained.
Work with others to define reporting parameters, and run reports.
Perform/Asist Internal QMS Audits.
Participate and support Non-Conformance and CAPA investigations and help to develop solutions to system and procedural issues.
Review of Quality Records for adherence to cGMP and GDP.
Support the maintenance and control of information in the site ERP System.
Perform all other duties as assigned.
BS Degree in a related scientific discipline preferred
AA/AS with two years minimum relevant experience will be considered
Experience with ISO 9001, ISO 13485, or ISO 16949 Quality Systems - preferred
Familiarity with medical device product manufacturing and assembly industries - preferred
Previous cGMP and GDP experience - preferred
Proficient in MS Office
Self-directed, the ability to work independently, and being highly-motivated.
Focused and able to carry out tasks in a timely and accurate manner.
Detail-oriented, dependable and trustworthy to manage complex and sensitive documents.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Thermo Fisher Scientific Inc.