Bausch Health Documentation Specialist in Wilmington, Massachusetts
Career Opportunities: Documentation Specialist (1995)
Job Requisition ID 1995 - Posted 09/15/2020 - US - Wilmington - Quality - US - Wilmington, MA
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.
Our approximately 21,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.
Responsible for the oversight of the organization and maintenance of the Documentum and ComplianceWire. Perform detailed review and approve device history records and release finished product. Maintain records in accordance with record retention policies. Ensures compliance with Quality System Regulations, ISO standards and internal/global policies and procedures. Maintains a teamwork approach to all tasks and nurtures professional relationships with other departments and outside agencies.
Oversee the organization and maintenance of all aspects of the document management system (GDMS) including modifications, approvals and distribution. Create, revise and approve documents as required by changes to policies or in response to compliance issues ensuring adherence to regulatory, global and internal requirements and deadlines.
Perform the Quality Assurance detailed review and approval of device history records and release finished product.
Coordinate, collect and analyze data and prepare reports forManagement Review and Product Quality Review meetings to allow for theassessment of the effectiveness of the Quality Management System, process performance and potential risks while ensuring compliance to both internal and external requirements.
Manage Compliance Wire training profiles and ensure compliance with annual training programs (e.g. ISO, QSR).
Manage the Record Retention program and maintain QA files according to record retention requirements.
Associate Degree required, Bachelors Degree, preferred
3-5 years of industry experience in a cGMP environment.FDA/ISO regulated environment experience preferred
Effective time management and organizational skills.
Proven communication and problem solving skills.
Effective computer, written, oral presentation and communication skills.
Excellent knowledge and use of MicroSoft Word, Excel and PowerPoint applications.
Strong personal accountability for project throughout its lifecycle including ownership of decisions.
This position may be available in the following location(s): US - Wilmington, MA
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.
Bausch Health is an EEO/AA employer M/F/D/V.
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