QUALITY ASSURANCE ASSOCIATE Resume

SUMMARY

I am a strategic and dependable Global External Quality Assurance Associate with five years of GMP/CGMP experience across the Biotech and Pharmaceutical industry.
I have the ability to effectively assess challenges and implement strategies to maximize results. I am a proactive, goal oriented, passionate, dedicated professional.
I have the ability to effectively manage multiple projects simultaneously as well as assess challenges and implement strategies to maximize results.
My unique background combines over 15 years of internal and external customer service experience, logistics, analysis, R&D (development), QA/QC, packaging and manufacturing operations support / production.
I possess strong project management skills which includes organization, communication, documentation, and cross - group collaboration.
I have the ability to analyze information, determine contexts, and take appropriate by choosing the correct course of action.
I possess superior analytical and technical skills, exhibit a strong attention to detail, and I am well-organized.

PROFESSIONAL EXPERIENCE

QUALITY ASSURANCE ASSOCIATE

Confidential

Responsibilities:

Change control management, product disposition, manufacturing operations, end of life cycle document management, transports, QP declarations, and authorization’s to manufacture.
Develops professional relationships with internal partners and external GMP partners with daily collaboration.
Compiles reviews & approves documentation for blinded & open label clinical trial supply studies.
Creates, updates, reviews and/or approves change controls, project related documents such procedures, forms, batch release templates, label templates, batch records, item specifications according to client requirements & project scope.
Responsible for gathering, analyzing and applying information from internal and external sources in order to perform risk assessments.
Compiles information and documentation packages for Regulatory Affairs groups for quarterly submissions to the FDA.
Conducts organized quality reviews and approvals of batch related documentation ( cGMP procedures, master production records, solution lot records, protocols and reports) to support manufacturing and manufacturing.

SR. PACKAGING OPERATOR / QUALITY ASSURANCE ASSOCIATE

Confidential

Responsibilities:

Reconciling batch record documentation, in turn boosted the turnaround time for batch review.
Reviewing, Revising & Routing of SOPs and Quality Agreements & other documents.
Performing audit reviews and risk assessments; Performed change control procedures.
Authoring & revised batch records to ensure documentation had the correct steps necessary to complete tasks.
Performing visual inspections and extensive proofreading of finished goods, retains & sampled labeling material.
Handling Supplier reassessments, audit reviews, and risk assessments.
Delegated and monitored multiple packaging lines while utilizing HMI Applications.
Included: Assisting with developing validation test & performed validation test (IQ, OQ, PQ).
Developed and lead training of inspection and packaging department personnel, which included coaching.
Included: Overseeing on-going training and departmental development.
Performed routine Preventative Maintenance (PM) work orders, and coordinated machine changeovers.
Included: Cleaning, changeover, setup, startup, operation, and breakdown of production lines.
Included: Logging preventative maintenance into SAP.
Streamlined and modernized procedure driven guidelines relating to deviation and complaint investigations.