Title: Senior Manufacturing Compliance Specialist
Work Location: Lexington, MA
Division: Pharma Services Group (PSG)
When you're 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.
How will you make an impact?
The Senior Manufacturing Compliance Specialist will act as a lead investigator to conduct deviations in support of all phases of bulk drug substance and drug product manufacturing for clinical and commercial products. The Manufacturing Compliance member is essential to ensure GMPs are being met and facilitating investigations through the site's Quality Systems using expertise of compliance, unit operations, and root cause analysis. This role will interface closely with other cross-functional groups such as, Facilities, Engineering, CQV, QC, Operations and Quality.
What will you do?
- Lead thorough deviations through the Quality System as a Lead Investigator. Drive investigations through the Quality System within established timelines.
- Author strong technical / compliance Deviation Reports.
- Facilitate root cause analysis through cross-functional collaboration.
- Works cooperatively with others to meet group and organizational goals.
- Proactively provides investigation status updates to stakeholders.
- Lead / facilitate discussions in a constructive and positive manner.
- Maintain tracking systems of manufacturing compliance priorities.
- Use knowledge of processes / unit operations to champion continuous improvements.
- Define, own, and support creation of corrective and preventive action (CAPA) plans.
- Support external audits performed by regulatory/inspection agencies or clients and audit/inspection readiness activities.
- May lead risk assessments as needed.
- Improve compliance within quality procedures, policies, and regulations.
- Participate in client and planning meetings as requested. Including but not limited to presentation and document preparation.
How will you get here?
BS/MS in Engineering or related science discipline and 5+ years of experience in a cGMP environment.
Experience in setting up GMP operations and systems in a new facility is beneficial, in addition to experience in cell or gene therapy.
Knowledge, Skills, Abilities:
- Proficient in writing Quality Systems including but not limited to deviations and CAPA
- Skilled in use of Microsoft Outlook, PowerPoint, Word, Excel and GMP system programs and spreadsheets is mandatory, as is a capacity to follow written procedures, and the ability to read, write, speak, understand and to be understood in English.
- This position requires the ability to work in a fast-paced team environment to meet goals and timelines and as such requires appropriate behavioral characteristics to be effective and successful.
- Individual must be self-motivated, have excellent quality and organization skills and be detail oriented.
- Strong planning, organization and multitasking skills.
- Strong Project Management skills.
- Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
- Ability to make decisions and work with minimal to moderate supervision.
- Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups.
- Solid understanding of regulatory requirements.
- Gown aseptically and/or sterile gown as needed.
- Regularly required to talk and hear. The employee frequently is required to sit and stand for extended periods.
- The employee is occasionally required to lift, stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, or crouch.