Quality Compliance Specialist

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

This position is required to provide comprehensive technical support and quality assurance oversight to maintain site compliance with GMP standards. Support functions which include, but are not limited to, documentation review, supplier management, process monitoring, change control, client relations and Quality Assurance. This role will interface closely with other cross-functional groups such as Operations, Maintenance, Engineering, R&D, Business Management and Quality.

• Continually improve required Qualifications, Validations and Risk Management activities
• Ensure Quality Agreements with clients are established and maintained
• Participate in the site's continuous improvement projects, PPI
• Develop and report metrics related to CLS Quality compliance and present to Senior management on a scheduled basis.
• Support site Data Integrity Initiatives
• Assist in taking part in the internal audit program.
• Lead the completion of action items associated to investigation reports related to compliance actions.
• Establish new procedures and update existing ones as appliable.
• Support review and implementation of corporate and division policies.
• Maintain site compliance with GxP's as related to US and EU clinical labelling
• Review all Quality Agreements and work with Client Services to ensure requirements are included in all client specific profiles.
• Support quality on the Change Control Committee
• Support the routing and approval of client Change Notifications
• Assist quality team as needed with any issues related to Global TrackWise or Documentum
• Provide support for site Documentum and Global TrackWise
• Other duties may be assigned to meet business needs.

• Knowledge of Quality Management Systems with at least 2 years of experience
• Experienced in working in project teams
• Knowledge of directives (EU-GMP, US FDA 21 CFR)

• Structured and very diligent working style including ability to organize yourself independently
• Analytical skills with proven ability to troubleshoot complex problems
• Strong interpersonal skills to work as a member of a team and collaborate effectively with other Teams and Functions
• Intermediate level skill in Microsoft Word, Excel, Outlook, and other office software programs.
• Excellent problem-solving, organizational, analytical, and critical thinking skills including high discretion/judgment in decision making
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Experience with Electronic Quality Management Systems, and electronic signature process compliant to FDA's Part 11 for electronic records

• Ability to function in a dynamic environment and balance multiple priorities simultaneously.
• Ability to learn new software and tools quickly.
• Ability to make decisions and work with minimal to moderate supervision.
• While performing the duties of this job, the employee is required to write, read/review written documentation for extended periods of time.

• 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