Job Description

When you are part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labeling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability, and sustainability standards. http://www.fisherclinicalservices.com/

• Proactively identifies and coordinates the reporting of Data Integrity issues and findings through Global TrackWise including reporting observations and ensuring changes are completed as per cGMPs.
• Coordinates actions for global harmonization of procedures across Clinical Labeling sites. Responsibilities include implementing and monitoring department gap assessments and completion tracking. Completes Quality gap assessments and documents updates where applicable.
• Supports the harmonization of key processes across all Clinical Labeling Services locations. Ensures SOP/WI's for designated critical processes are applied at other CLS sites and any translated items are associated within Documentum to the primary SOP/WI.
• Assist in supporting the management of Documentum (Electronic Document Management Systems, eDMS) for the site with responsibilities for the final release of all quality-controlled Forms, WIs, SOPs, and Manuals ensuring that the documentation is aligned with local and corporate attributes.
• Supports internal authors and Subject Matter Experts (SMEs) with the use of Documentum, for document creation, revision, and management.
• Monitors all Periodic Reviews from issuance to completion.
• Handles the creation and release of site logbooks.
• Provides Right First Time, monthly business review site metrics, and department metrics to the QS Manager and site QA Analyst on a routine basis as part of Continuous Improvement efforts.
• Participates in, Practical Process Improvement (PPI) teams.
• Applies Good Manufacturing Practices principles in all areas of responsibility.
• Demonstrates and drives the Thermo Fisher values - Integrity, Intensity, Involvement, and Innovation (The Four Is).
• Ensures appropriate execution of Quality Systems (QS) to sustain cGMP compliance.
• Coordinates the disposition and destruction of batch records as per corporate guidelines.
• Raises issues to Quality Systems Management as needed.
• Other duties may be assigned to meet business needs.

• Minimum requirements include associate degree.
• Equivalent combinations of education, training, and meaningful work experience may be considered.

• A minimum of 5 years of meaningful experience in the pharmaceutical industry or 3 years with an advanced degree.

• Knowledge of cGMPs
• Outstanding problem-solving skills
• Attention to detail
• Ability to multi-task
• Excellent oral and written communications skills
• Ability to work with company/client confidential information
• Communicate effectively with all levels of personnel
• Work efficiently and accurately in a fast-paced environment

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount