Quality Assurance Manager

SUMMARY

Quality Assurance Specialist with extensive experience in highly-regulated Pharmaceutical and Biotech manufacturing industry. Expertise in batch record review, aseptic processing, and investigations (including root cause analysis and CAPA). Well versed in corporate and regulatory compliance protocols (FDA, EMA, cGMP, SOPS). Highly meticulous and detail-oriented with excellent accuracy and follow through. Strong individual contributor and team member who interacts well at all levels.

SKILLS

ICH Guidelines, Code of Federal Regulations, Good Documentation Practices, Good Manufacturing Practices Aseptic Processing, Aseptic Gowning Certification, CAPA

SYSTEMS

SAP, PDOCS (GxPharma), LIMS, Trackwise, Plateau, EDMS, Outlook, Windows NT

Microsoft Office (MS Word, Excel, PowerPoint)

EXPERIENCE

Pfizer Global Manufacturing Pearl River, NY

Quality Assurance Specialist IV Shop Floor

Provides direct quality assurance support to the manufacturing operations and shop floor.

Performs inspections on product, packaging, and labeling to ensure product meets GMP and AQL standards.

Reviews and approves formulation and pack batch records to ensure compliance with GMP requirements.

Maintains Gowning Certification in order to review aseptic processing performed during formulation and fill activities.

Authors and reviews protocols as required by production.

Performs line monitoring to ensure compliance with GMP requirements.

Performs audits on equipment and cleaning logbooks and environmental data.

Actively participates in investigations and compliance related issues.

Reviews and provides final approval for investigations and associated CAPAs.

September 2010 present

Wyeth Vaccines Pearl River, NY

Quality Assurance Specialist III

Reviews and approves formulation and fill production batch records from the Clinical Supply Materials Department (CSMD) to ensure compliance with GMP requirements.

Reviews and approves label and pack batch records to ensure compliance with GMP requirements.

Assists in creating master batch records for formulation/fill and label/pack activities.

Performs review and disposition of components to be used in formulation and fill activities.

Conducts walk-through inspections of the batching suite and associated areas.

Reviews and approves change controls.

Performs audits on equipment and cleaning logbooks and environmental data.

Writes and reviews release protocols.

Reviews and approves Temperature Deviation and Environmental Trending Reports.

Reviews, revises, and approves SOPs to comply with Conformance Standards.

Initiates Manufacturing Investigation Reports (MIRs) as needed.

Maintains Gowning Certification in order to review aseptic processing performed during formulation and fill activities.

Provides audit support and interacts directly with auditors to explain processes.

September 2007 September 2010

Wyeth Research Pearl River, NY

Scientist II (Stability Project Manager)

Writes protocols and maintains stability studies for drug product and drug substance studies.

Writes and reviews stability reports in support of regulatory submissions for drug products.

Performs LIMS stability study entry and maintenance for drug product and drug substance studies.

Provides analytical data to establish API and product specifications, revalidation periods, and POUs.

Initiates Laboratory Investigation Reports (LIRs) as needed and determines stability impact assessment of LIRs related to assigned projects.

Writes and reviews batch records used for NDA packaging.

Performs line monitoring in the packaging/labeling of NDA samples in order to ensure compliance with batch records.

Performs study initiation, sample shipping, receiving, and pulling stability samples.

Issues and tracks experiment numbers for all clinical and formulation studies.

Assists in maintaining and controlling stability chambers.

Reviews and approves PMOs for stability chambers and related equipment.

Performs monthly safety inspections and provides monthly safety lectures and training as an active member of Safety/Housekeeping/Documentation Committee.

Generates, revises, and performs training on SOPs.

December 2000 August 2007

Novartis Suffern, NY/East Hanover, NJ

Stability Coordinator

Collected daily samples to be delivered to laboratory for testing.

Participated in the movement of product to new manufacturing site.

Created new stability studies for reduction of backlog.

Modified existing stability studies for corrections.

Created filing system for old and new stability documents.

Responsible for documentation and tracking of incoming products.

March 2000 December 2000

EDUCATION

MS Quality Assurance/Regulatory Affairs (2012) - Temple University School of Pharmacy, PA - GPA 4.0

BS Biology (1999) – Binghamton University (SUNY), NY – GPA 3.3

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