Novartis - QUALITY Begins with Me!
Compliance Specialist - Cardiovascular Support Operations
October 2012 — Present
Making QUALITY medicine On Time, Every Time!
Your amazing online presence is right this way.Create your profile
Compliance Specialist at Novartis Suffern
Making QUALITY medicine On Time, Every Time!
PSC Biotech Corporation is a global, employee owned, life sciences consultancy that performs projects and staff augmentation in the following disciplines: Engineering, Information Technology, Technical Services, Validation, Compliance, Regulatory Submissions, Clinical, Project Management and Quality Assurance.
Client: Lonza Biologics
Completed Masters of Engineering in Pharmaceutical Manufacturing and Graduate Certificate in Project Engineering in Pharmaceutical Manufacturing.
Client: Stryker Orthopaedics
Prepared documentation related to the validation lifecycle including: user acceptance tests, factory acceptance tests, user requirements, functional specifications, design specifications, validation plans, risk assessments, traceability matrices, Installation Qualification (IQ), Operational Qualification (OQ), & Performance Qualification (PQ) protocols and reports.
Executed qualification (IQ, OQ, & PQ) protocols.
Prepared standard operating procedures and work instructions.
Performed compliance audits along with senior colleagues.
Prepared other technical documentation as required by the client or project.
Administered a fast-paced Non-Conformance process
Managed 500+ Non-Conformances and managed daily entry of data into web-based database system
Facilitated and guided investigations by using 4-D problem solving techniques and developed a strong working relationship with Operations, Manufacturing and Quality
Generated and provided Quality Performance metrics to management leadership team
Provided support to the Operations Quality Assurance department during an FDA inspection
Ensured overall compliance to data integrity and company document change control requirements
Prepared documentation related to the validation lifecycle of the company’s Packaging Assembly Cleanroom including: user acceptance tests, factory acceptance tests, user requirements, functional specifications, design specifications, validation plans, risk assessments, traceability matrices, Installation Qualification (IQ), Operational Qualification (OQ), & Performance Qualification (PQ) protocols and reports
Executed qualification (IQ, OQ, PQ) protocols
Prepared Standard Operating Procedures and Work Instructions
Prepared other documentation as required by the client/project or manager
Scaled up and ran numerous batches of dental cream formulation in Pilot Plant to improve the existing process for large scale use
Reviewed, analyzed, summarized and interpreted data results
Performed sample analysis using Brookfield viscometer and specific gravity
Prepared small scale batches of dental cream variants on small Ross equipment varying SLS percentages for NIR development and pilot plant scale production
Increased awareness and support for SHPE and its mission within the local community
Served as the point of contact for the organizational and financial matters of the chapter, as well as all other business concerning the chapter according to policies and guidelines set and approved by the chapter.
Chaired and presided at chapter board, general, and special meetings.
Ensured that chapter members were taking advantage of all the benefits SHPE had to offer, including programs and events throughout the academic semester.
Worked with local student and SHPE Jr. chapter presidents to foster a strong relationship between professional and student members.
Established important partnerships with local corporate sponsors and community organizations in matters of common interest.
Manufactured small scale batches of fabric softener formulation in Pilot Plant for qualification and validation of batch making equipment
Analyze product release specifications using viscosity, solids, pH, particle size distribution and performed stability aging
Operated pilot plant equipment and instrumentation control
Executed equipment qualification, including PQ and Cleaning validation activities
Adhere to appropriate GMP documentation and recording analytical results, statistical analysis, microbiological data and stability data for validation records
Demonstrated comprehension of chemical process equipment operation and principles of validation as related to consumer products industry
Presented pilot plant validation findings to Senior Management and intern colleagues.