Quality Assurance Analyst Resume

SUMMARY

Strong experience in R&D, quality assurance and Medical Device Quality System.
Designing, implementing and testing of new method and process.
Working closely with various departments R&D, Quality, to meet quality system requirements.
Experience with OOS, CAPA.
Participating in internal FDA auditing.

TECHNICAL SKILLS

Microsoft Office
SAS, MATLAB
Master Control
LIMS
Chemstation, Empower
Chromatography gas and liquid (GC & HPLC)
pH meter, microscope, UV - VIS, Fluorimetry
FDA audit
Method development and Validation
Strong analysis and problem-solving skills
Multitasking skills
Quick learner
Great communicational and interpersonal skills
Fluent in French
ISO
GMP, GCP, GDP, GLP

PROFESSIONAL EXPERIENCE

Quality Assurance Analyst

Confidential

Responsibilities:

Supplier Quality Oversight
Supplier change notification impact assessment and implementation
Liaise with suppliers in addressing nonconformities through investigations. Assess and determine appropriateness of corrective/preventive actions to avoid recurrence
Serve as primary liaison between EDMS Global Administrator and Baltimore’s EDMS users to maintain EDMS functionality and perform administrative activities for the applicable software
Serve as technical expert to assist and provide support to end users. Provides EMDS users with Level appropriate training as required and maintains EDMS training materials
Serve as a liaison between LMS Global Administrator and Baltimore’s LMS users to maintain LMS functionality and perform administrative activities for the applicable software
Ensure document lifecycle from generation of document to archival
Maintain Emergent’s Quality Systems including, but not limited to, Deviations, CAPAs, Change Control, and Management Review in support of manufacturing operations
Lead or participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product
Prepare functional and Management Review metrics for identification of negative trends. Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team.
Independently review and perform disposition of raw materials, components, bulk drug substance, and final drug substance
Liaise with contract manufacturers responsible for filling, inspection, labeling, and packaging of product by providing Quality oversight for deviations, change controls, and other quality systems that may impact EMOB’s products
Assist with the oversight of Support the reference and retention programs

Quality Assurance scientist

Confidential

Responsibilities:

Reviewing, and approving PBR, DHR and CoA.
Writing NCMR and deviation for non-conforming materials.
Testing for approval or quarantine of manufacturing finished goods.
Writing OOS or OOT reports.
Testing of raw materials, batches and finished products for new and existing Products.
Standardization of lab reagents
Viscocity testing of finished products
IR, NMR, pH titration

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