QA Compliance Specialist - Full-time / Part-time

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 drug supply chain or making sure our medicines are safe, efficacious, and of impeccable quality. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location

Lexington, MA

How will you make an impact?

The QA Compliance Specialist will act as a direct liaison between departments and the site’s quality unit to ensure adherence to expectation of the GMPs are being met and facilitating projects through the site’s Quality Systems. This Quality Assurance member is essential to maintaining the site’s right-to-operate in support of producing and releasing quality bulk drug substance and drug product for clinical and commercial products. This role will interface closely with other cross-functional groups such as Operations, Facilities, Engineering, QC, Business Management and Quality.

What will you do?

• Lead and/or support thorough investigations of client-related quality issues (CAPAs, Discrepancies, Audit Observations, etc.) ensuring effective corrective and/or preventive actions occur.
• Compile metrics and report to management. Create tracking system and method of accountability for closure of GMP quality events and documents.
• Perform documentation coordinator activities and work with departments on documentation needs.
• Provide quality oversight of client product related topics including but not limited to deviations, change controls, documentation, batch record reviews, batch release, and specification management.
• Interface with clients by assisting with addressing their questions and concerns as they relate to site strategy for controlling product quality through quality systems.
• Participate in cross-functional teams on process control, improvement, and optimization projects; participate in other continuous improvement projects to enhance client satisfaction.
• Participate in audits and inspections performed by clients.
• Participate in inspections by regulatory agencies, as needed

How will you get here?

Education

• Bachelor's degree in Life Sciences minimally required, preferably in Biology, Chemistry, or Chemical Engineering; Master's degree is a plus

Experience

• At leas 8 years of experience in a cGMP environment, with strong knowledge of FDA, EU, ATMP and JP regulations.
• Proficient in writing and approving Quality Systems including but not limited to deviations, change controls, CAPA
• Experienced in developing and reporting metrics
• Demonstrated ability in performing document coordination and archival activities
• Experience in setting up GMP operations and systems in new facility is beneficial, in addition to experience in cell or gene therapy.

Knowledge, Skills, Abilities

• 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.
• 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.
• Able to review and provide details to ensure accurate written records, manage time effectively and be organized

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today!

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.