Business Analyst IT II Resume

SUMMARY

Business Analyst with 25 years of experience in both pharmaceutical and consumer companies working in regulated cGMP and GLP environments.
Skilled in development, validation and transfer processes for compendial and analytical methods for both raw materials and finish products.
Assisted regulatory affairs department method submissions to FDA to ensure compliance with 21 CFR part 210, 211 and 820 regulations.
Excellent problem solving, troubleshooting, and collaborative skills.

AREAS OF EXPERTISE

PROFESSIONAL EXPERIENCE

Confidential

Business Analyst IT II

Responsibilities:

Create, Review, Testing and Manage documentation of Master Data for system updates within Laboratory Systems (LIMS, Empower, SDMS, ELN) in accordance with Standard Operating Procedures by using current business processes
Creation and management of documentation for change requests, and participation in system related project activities
Works with the user community to assure Lab systems are being properly integrated into the business process to maximize the benefits to the user community. Collaborates with IT, CSV, internal site, business partners and others as needed
Develops training and delivers to colleagues and partners
Works independently, challenges the status quo, identifies gaps and drives process improvements using Process Excellence tools
Interface with internal customers, identify needs, and translate into actionable system design and configuration
Work with IT to deliver systems and updates to customers.
Create, Manage, and Maintain system related documentation (product test specification, procedures, events, etc) via the appropriate applications (Docspace, TrackWise, Pharmadoc, or any other designated system)

Confidential

QC Chemist

Responsibilities:

Performed analysis of raw materials and finished products using state of the art analytical technology
Validate, optimizes, and troubleshoot Analytical Methods used in the Quality Control Laboratory
Contributed to improved accuracy, productivity and reliability within TD Analytical Support
Used creative approaches to solving problems; highly effective in day to day troubleshooting
Worked with Laboratory Systems and LIMS - fully compliant with current GM’s and SOPs
Taught/mentored Assistant and Associate Scientists
Planned and executed experiments with minimal guidance, interpreted data
Performed analyses in a highly compliant and safe manner with minimal supervision
Performed instrument calibrations on balance, High Pressure Liquid Chromatography (HPLC), and Gas Chromatography (GC), maintained equipment, project, and general QC logbooks
Investigate analytical/manufacture production non conformances (complies, trends and analyzes test information to determine root cause and CAPA actions then interpret results in written and/or oral format
Follow up on Root cause/CAPA with change control, method validation, or method revision
Liaison with QCM, Analytical Chemist, other departments, and client to verify timelines and reassure that methods and specifications are created and approved in a timely manner

Confidential

Residential Assistant Manager

Responsibilities:

Manage the on going operations and activities of the residence
Conduct employment interviews, make hiring decisions, a ddress staff concerns as needed
Set weekly work schedules, daily priorities and assign tasks /projects to all team members
Monitor and provide staff supervision and all aspects of consumer support
Coordinate/provide all necessary agency and intra-program staff training
Provide staff with all necessary information needed to effectively carry out their job duties
Coordinate consumer related meetings and ensure all necessary follow up is completed
Complete and submit all required daily, weekly, bi-weekly, monthly, quarterly and annual reports as scheduled
Inform upper management about pertinent issues
Handle and document all financial transactions for consumer and residential accounts

Confidential

Office Manager

Responsibilities:

Manage development operations including organization and staffing
Conduct employment interviews, make hiring decisions
Participate in corrective action, termination discussions and decisions
Set weekly work schedules, daily priorities and assign tasks /projects to all team members
Monitor and provide periodic status updates on all projectsand reports in relationship to office static progress
Monitor employee performance to ensure consistent, effective and efficient processes
Prepare and deliver associate quarterly performance reviews for 17 associates, including performance metrics for each performance objective
Complete and review tax return for small business clients
Identify and solve customer related issues
Interact with clients and provide prompt and courteous customer service
Provide office status update reports to District Manager on weekly basis

Confidential

Scientist-Development-Analytical Support

Responsibilities:

Performed analysis of raw materials and finished products using state of the art analytical technology
Validate, optimizes, and troubleshoot Analytical Methods used in the Quality Control Laboratory
Investigate analytical non conformances (complies, trends and analyzes test information to determine root cause and corrective actions then interpret results in written and/or oral format)
Used creative approaches to solving problems; highly effective in day to day troubleshooting
Worked with Laboratory Systems and LIMS - fully compliant with current cGMP’s and SOPs
Taught/mentored Junior and peer Scientists
Planned and executed experiments with minimal guidance, interpreted data
Performed analyses in a highly compliant and safe manner with minimal supervision
Reviewed paperwork and results of Junior and peer Scientists
Assessed business impact of test results
Built supply chain partnership