Compliance Specialist I, Manufacturing Compliance

Compliance Specialist I, Manufacturing Compliance

Location / Division / Shift

Thermo Fisher Scientific’s Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy Contract Development and Manufacturing Organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future!

Location: 5 Commerce Boulevard Plainville, MA
Shift: M-F 1st Shift (7am-4pm)

How will you make an impact?

The Manufacturing Compliance Specialist will be part of a cohesive team responsible for manufacturing compliance. The Manufacturing Compliance Specialist I will act as a lead investigator 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 sites 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, MS&T and Quality.

What you will 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.
• 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.

How you will get here…

Education

• Associated Degree or BS/MS in Engineering or related science preferred.
• HS Diploma/GED with a STEM/Biotechnology certificate and experience will be considered.

Experience

• 1 years of industry experience preferred.

• Experience with single use disposable systems and technology and or experience in cell or gene therapy is beneficial.

Knowledge, Skills, Abilities

• Skilled in use of Microsoft Outlook, PowerPoint, Word, Excel and GMP system programs and spreadsheets is mandatory, has is a capacity to follow written procedures, and the ability to read, write, speak, understand and to be understood in English.
• Strong analytical and problem-solving skills; great attention to detail and excellent decision-making process.
• Basic knowledge of cGMPs.
• Excellent written and oral communication skills.
• Individual must be self-motivated, have excellent quality and organization skills and be detail oriented.
• Strong planning, organization and multitasking skills.
• Ability to make decisions and work with minimal to moderate supervision.
• Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
• Must be fluent in English

Physical Demands/Factors

• Gown aseptically and/or sterile gown as needed.
• Write, read/review written documentation for extended periods of time.
• 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 120,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.