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location: North Billerica, Massachusetts
job type: Permanent
salary: $52 - 70 per year
work hours: 9 to 5
The Quality Document Specialist is an individual contributor who is responsible for conducting day to day processing of document workflows for cGMP operations. Will assist with ongoing quality documentation deliverables driven by business objectives and identified by management.
- Coordinates, authors, proofreads, formats, troubleshoots issues and distributes controlled documents supporting the manufacturing and testing of products.
- Balance and prioritize assigned workload to meet requested timelines.
- Aligns with all levels of the organization to meet the needs of documentation system users on site and at external facilities.
- Manages multiple tasks in a fast paced and dynamic environment while maintaining focus on quality and compliance with local SOPs, policies and directives, and regulatory requirements.
- Supports individual and group training sessions for system users on making document changes and reviewing electronic references copies of documents.
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
- Actively demonstrates the company values of accountability, quality, efficiency, customer service, collaboration and safety.
- * In the case of absence the reports to Manager above or a peer incumbent will function as a backup for this position.
- AS in English or Science.
- A combination of education, training and experience may be considered in lieu of the above stated qualifications.
- 4-6 years of experience in the pharmaceutical industry, preferably within quality or Documentation function
- Prior experience with Electronic Documentation Management System is preferred
- Proficient in Microsoft Excel
- Proficient in advanced functions of Microsoft Word
- Excellent verbal and written communication
- Ability to work independently to resolve issues and meet the required issue date for documents
- Ability to work in a team environment
- Attention to detail
- Some overtime may be required.
skills: Quality control, SOP, MS-WORD, MS-EXCEL, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.