Sr. Specialist, Records and Knowledge Management
6 Months- likely to go much longer
Marlborough, MA
Hourly Pay: $62
Job Summary
In this role, you will support the Records Management and Knowledge Management will be responsible for maintaining documents in compliance with business needs and regulatory expectations. The individual will be responsible for formatting and administration of paper-based and electronic document workflows. Additionally, this individual will be responsible for leading and managing the training program for the Marlborough INT site. This individual should possess excellent organizational skills, the ability to work independently on multiple tasks, and the ability to work in a fast-paced environment are required.
Job Responsibilities
- Manage an effective GMP training program within the site to ensure employees are fully aware of GMP expectations and requirements and effectively demonstrate this awareness as part of their core competencies.
- Create and track Training metrics/reports to measure training effectiveness and accountable for escalation of training quality system issues.
- Collaborate with clinical GMP area managers to analyze needs and develop, implement, and measure effectiveness of training and work with individual department leads to develop job specific training matrices.
- Oversee the management of cGMP training files in the electronic document management system.
- Provide support and oversight of course development, training structure, and design across the site.
- Organize and present live and virtual training sessions to groups and individuals (e.g., annual GMP)
- Support cross functional teams in processing document requests, document approval, and document archival.
- Business administration tasks within eDMS.
- Assist in document control process improvements with Document Types, Lifecycles, and Workflows in eDMS.
- Maintain periodic review process for documents.
- Collaborate with cross-functional teams to identify efficiencies around maintenance/control of paper-based documents.
- Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.
- Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
- Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
- Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
- Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
- Additional duties as may be assigned from time to time
Education & Qualifications
- Education: Bachelor's or Master's degree, preferably in Sciences or Engineering
- Experience: BS/BA with 4+ years of biotech or pharma experience, MS with 3+ years' experience.
- Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards).
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.