Company: Thermo Fisher Scientific Location: Lexington, MA Employment Type: Full Time Date Posted: 02/02/2021 Expire Date: 05/01/2021 Job Categories:
Accounting/Auditing, Healthcare, Other, Information Technology, Quality Control, Medical, Writing/Authoring
QA Compliance Lead
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 QA Compliance Lead 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?
QA Compliance Lead will lead and / or support thorough investigations of client-related quality issues (CAPA’s, Deviations, Audit Observations, etc.) ensuring effective corrective and / or preventive actions occur.
Liaise with global functions and other VVS sites to develop comprehensive metrics in alignment with PSG global policies. Develop tools and compile metrics for reporting to management. Create tracking system and method of accountability for closure of GMP quality events and documents.
Participate in Quality Management Reviews and ensure departments focus on continuous improvement.
Provide quality oversight of client product related topics including but not limited to deviations, change controls, documentation, and CAPA.
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.
Coordinate audit request tracking and fulfillment during client audits and agency regulatory inspections
Perform document management activities such as formatting, approval, issuance, scanning and archiving
Support management and facilitiation of site review boards such as CAPA, Change Control and Deviation
Manage Internal Audit program and ensure inspection readiness at all times
How will you get here?
BS/MS in Biology or related science discipline
8+ years of experience in a cGMP environment, with strong knowledge of FDA, EU, ATMP and JP regulations.
Experience in setting up GMP operations and systems in new facility is beneficial, in addition to experience in cell or gene therapy.
Proficient in writing and approving Quality Systems including but no limited to deviations, change controls, CAPA
Experienced in the use of root cause analysis tools
Experienced in developing and reporting metrics
Demonstrated ability in performing internal audits
Experienced in supporting regulatory inspections
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.
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.
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.
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.