PROFESSIONAL EXPERIENCE:

Confidential, ATLANTA, GA

SR. QUALITY ANALYST

Responsibilities:

• Responsible for reviewing and approving Validation and Technical Reports and Annual Product Reviews (APRs).
• Establishes and evaluates quality metrics and conducts trend analysis and provides corrective actions when necessary.
• Works closely with Technical Operations to ensure that all critical and major quality manufacturing issues are thoroughly investigated.
• Responsible for reviewing and assessing deviations, OOS investigations, Corrective and Preventative Actions (CAPAs); including tracking, follow - up and reporting/trending,
• Maintains cGMP related SOPs in compliance with all applicable requirements and aligned with existing company policy.
• Ensures contract manufacturing and analytical testing are performed in accordance with applicable company procedures and are in compliance with all applicable regulatory requirements.
• Identifies compliance risk and recommends solutions.
• Participates in Regulatory Inspections.
• Responsible for managing the Stability program for all products.

Confidential, MCDONOUGH, GA

QUALITY SYSTEMS MANAGER

Responsibilities:

• Responsible for planning, organizing, leading, and controlling of the Quality System (ISO9001) function within the RxO facility.
• Accountable for managing 4 quality systems supervisors. Evaluated performance expectation plans with supervisors and associates to meet individual goals and facility objectives.
• Worked in conjunction with Plant Leadership Team to ensure conformance to requirements.
• Responsible for using statistical tools to enable process analysis, root cause analysis/problem solving and developing/executing action plans that will minimize process variation resulting in sustainable product quality improvements.
• Responsible for developing enhanced measurement processes/techniques to enable minimization of measurement system variation resulting in enhanced product quality for consumers.
• Communicated effectively at multiple levels in the organization to achieve leadership alignment to improve quality.
• Summarized complex issues into visual presentations that enabled management to drive fast solutions.
• Lead teams in use of Lean Tools to drive continuous improvement including the use of documentation systems to institutionalize activities.
• Managed site calibration audit program to ensure all calibrations were being executed as per expectations on time. Also, managed site process audit program.
• Facilitated data collection, summary and analysis to support problem solving activities that lead to root cause problem solving, team building strategies, process control methods, and continuous improvement actions in order to meet or exceed the facility key internal and external operating metrics.
• Responsible for reviewing and approving controlled documents such as SOP’s, Test Methods and also Equipment Validation protocols such as IQ, OQ and PQ protocols.

Confidential, UNION CITY, GA

SENIOR QC ASSOCIATE II

Responsibilities:

• Functioned as back-up for the department manager when needed due to increased workload or absence.
• Primary departmental resource for management of all Quality Control laboratory equipment including scheduling of routine and non-routine maintenance and calibration, troubleshooting equipment related issues and working with outside vendors.
• Owned and implemented Change Controls related to Raw Materials and new and existing Quality Control equipment, manages changes, executes equipment IOQ Protocols, escalates implementation issues to management and assesses validation deviations for impact to equipment and overall project.
• Conducts Quality Control laboratory investigations related to laboratory equipment and/or Raw Material issues. Provides technical expertise and testing support of other departments as part of cross-functional project teams.
• Participates in planning and execution of process improvement activities at the departmental and inter-functional level for the Quality Control labs.
• Executes testing, including visual inspection and Certificate of Analysis verification, as part of the incoming Raw Material testing program. Works with contract testing labs to obtain outsourced testing results. Coordinates activities with Procurement and Quality to ensure timely ordering, testing and disposition of Raw Materials for use in Quality Control and Manufacturing.
• Performs ongoing assessment of development and training needs of staff to ensure continued development of personnel. Coordinated On the Job Training (OJT) for Bioassay and Microbiology departments.
• Represents Quality Control as a Safety Committee member. Certified as a First Responder.

SENIOR QC ASSOCIATE I

Responsibilities:

• Performs routine and non-routine analysis of raw materials.
• Technical expert for Raw Materials and all Quality Control laboratory equipment issues.
• Coordinated routine and non-routine equipment maintenance for laboratory equipment.
• Authored and reviewed Standard Operating Procedures for laboratory control systems and QC programs.
• Performed Annual Audits of QC Software Applications of QC equipment.
• Trains other QC personnel on Raw Material testing and specific procedures within the Lab Support Services Group.
• Represents department in cross-functional teams, projects and GXP-related problem resolution
• Coordinates On the Job Training (OJT) for Bioassay and Microbiology departments.

Confidential, DULUTH, GA

SENIOR SCIENTIST

Responsibilities:

• Responsible for quality testing of raw materials, in-process materials, formulations and lenses as needed to support all manufacturing platforms.
• Defines and solves technical problems within a defined scope.
• Assists with validations and special project work.
• Prepares written technical reports.
• Assists in writing standard operating procedures and non-conformance reports as required.
• Develop new test methods as needed.
• Maintained and calibrated lab equipment.

Confidential, SUFFERN, NY

SCIENTIST

Responsibilities:

• Responsible for a variety of routine and non-routine complex scientific tests utilizing laboratory apparatus, including the generation, analysis and recording of data, with less than daily supervision.
• Analytical testing of pharmaceutical materials in a GMP / FDA regulated environment as part of a self-directed team.
• Responsible for providing training to other individuals.
• Regularly perform troubleshooting of analytical and instrumental issues.
• Validate the completed work of others, evaluate anomalous results.
• Conduct and document laboratory investigations.
• Worked independently on projects.
• Safety Representative for Stability Laboratory which includes Safety Equipment monitoring and training assistant.

Confidential, CARMEL, NY

SCIENTIST

Responsibilities:

• Performed quantitative and qualitative analyses of pharmaceutical materials including but not limited to, In-House Reference Standard qualification, Method Validations, Method Comparisons, Method Transfers, and routine and non-routine studies of raw material, in-process and finished product samples according to written procedures and protocols.
• Writing Standard Operating Procedures and General Test Procedures as necessary.
• Labeled, transcribed and recorded data in laboratory notebook or on approved report sheets to maintain records of tests and assays.
• Validate work performed by peers.

Confidential

ANALYTICAL CHEMIST

Responsibilities:

• Analyzing pharmaceutical products (solid dosage tablets, capsules and syrup forms) on trial to determine shelf life.
• Responsible for quality testing of raw materials, in-process materials and finished products.
• Investigating customer complaints and product queries.
• Responsible for updating Standard Operating Procedures and specifications.
• Performed Method Validations and Method Development.
• Troubleshooting and problem solving of analytical and instrumental issues