An exciting opportunity has arisen for a QA Documentation Specialist to join a global biopharmaceutical company based in the US. A very patient-focused company, who scientific research has resulted in 15 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
- Ensure the correct and timely implementation of Change Requests (CR), Document Change Orders (DCOs) and Documents.
- Maintain documentation manuals to ensure accuracy and current information.
- Ensures the correct and timely input of database entries, verifies own work.
- Support the distribution and maintenance of GXP documentation.
- Scan, verify and archive documentation as needed and recommend process improvements and proposes changes.
- Provide support with internal and regulatory audits/inspections as required.
- Provide user training for electronic systems (as applicable).
- Support the maintenance of monthly document control metrics.
- Perform general word processing tasks and support.
- Check formatting and conformance to document templates, verifies own work.
- Provides additional support and assistance on tasks and projects as directed by management.
- Participates as required in training on issues affecting own area of work.
- Notifies manager of compliance questions and issues.
Skills and Requirements:
- Relevant experience typically includes document management and systems experience.
- Ability to work efficiently with attention to detail
- Ability to demonstrate excellent verbal, written, and interpersonal communication skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Christopher Frank at [click here] or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.