Analytical Support, Quality Control

hace 4 semanas


Madrid, España Moderna Therapeutics A tiempo completo

**The Role**:
Reporting to the Associate Director of Quality Control, this individual will be responsible for coordinating Quality Control Operations team. The individual in this role will focus on coordinating QC Associates in support of Analytical QC activities including stability, release and investigation testing under cGMP regulations.

**Here’s What You’ll Do**:
Coordinate a team of associates in support of QC testing for stability, release, and investigation samples.

Manage QC OOS/OOT investigation, deviations, change controls, CAPAs in quality management documentation system.

Execute test methods & assays as needed to support team throughput.

Review of executed assay packages, in both paper and electronic formats including review of chromatography data and other analytical outputs.

Ensure proper data review procedures are followed for in LIMS and in paper worksheets.

Manage the data trending and analysis as applicable.

Manage continuous improvement for data review requirements and processes to ensure delivery of highest quality of data.

Establish the Certificate of Analysis generation and review process.

Leads troubleshooting of methods and equipment.

Author/review/approve SOPs, test methods, QC release documents, instrument qualification documentation, computer system validation documents, training documents and method lifecycle documents as needed.

Interact, on daily base, with on-Site AS&T team in terms of analytical method topics, resource management (people, instruments, materials), business process optimization, etc..

Participate in cross functional planning to align QC resources and constraints with business objectives. Prepare, provide and manage schedules for testing to meet project timelines.

Coordinate and manage stability testing in partnership with QC Sample Team.

Develop and manage scheduling and status monitoring tools to measure testing capacity, turnaround time and to communicate progress to the larger organization.

Provide guidance and support to the QC team for compliance issues. Support preparation, management and response to compliance audits.

Manage continuous improvement projects to reduce paperwork, increase team working efficiency while maintaining compliance.

Participate in and partner with the Digital team to expand and optimize the use of the LIMS (LabVantage) system.

Participates in project meetings to provide status updates to stakeholders.

Coordinate training, professional development and growth of the QC Associate and Specialist team.

Establish and maintain a safe laboratory working environment.

**Here’s What You’ll Bring to the Table**:
BS/BA and minimum 7-10 years in cGMP environment. 2-5 years in a leadership role.

In-depth knowledge of relevant FDA, EU, ICH guidelines and regulations.

In-depth experience and technical knowledge of analytical methodology. HPLC/UPLC experience is a must have, additional experiences with particle analysis, plate-based assays, GC, KF, Osmolality are preferred.

Proficiency and experience with scheduling, planning or project management skills, including detailed instrument and analyst scheduling.

Strong knowledge of digital quality systems (LIMS, QMS, CDS) preferred.

Excellent quality control judgment and ability to assess, communicate and resolve complex issues efficiently and effectively.

Outstanding communication skills (verbal and written).

Ability to manage multiple projects in a fast-paced environment.

Ability to collaborate effectively in a dynamic, cross-functional matrix environment

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groun



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