RAHKEM D. FOWLER
Cincinnati,OH
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Skilled in reporting and problem-solving with a history of making a positive impact on operations. Willingness to take on added responsibilities to meet team goals.
Overview
10
10
years of professional experience
Work History
BULK / FORMULATION MECHANIC TECHNICIAN
AstraZeneca Pharma. /National Resilience, Inc.
04.2019 - Current
- Processing of raw materials with high quality focus, in order to produce quality finished bulk product
- Cleaning and sterilization of processing tanks and lines between batches to ensure that product is made under highest quality conditions
- Performs batch record and GMP documentation entries
- Maintains records and/or logs as required in performance of job responsibilities
- Collaborates with team throughout shift, department, and site
- Uses systems including SCADA, SAP, RTIP, etc to track batch progress and ensure nominal conditions are maintained
- Resolved mechanical issues using both technical and manual skills
QUALITY ASSURANCE SPECIALIST
AstraZeneca Pharmaceuticals
04.2018 - 04.2019
- Maintained a high level of understanding of relevant production processes and quality systems
- Executed QA processes including batch record review, component disposition and quality issue resolution to maintain the flow of products and documents to meet site objectives
- Collaborated with other Quality professionals across the organization to ensure consistent application and execution of key quality systems
- Benchmarked internal and external QA practices to identify innovative efficient and effective practices
- Used SAP to identify inventory and materials
- Performed and trained others on AQL sampling of finished product and inspection by attribute to ensure quality production
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Analyzed quality and performance data to support operational decision-making.
- Promoted adherence to quality standards by educating personnel on quality control.
- Addressed non-conformance issues, pausing production to correct errors.
- Updated inspection journals and daily summary logs with quality-related data.
- Fixed identified issues to increase productivity and boost workflows.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Reported problems and concerns to management.
- Inspected items and compared against standards to meet regulatory requirements.
- Reviewed production processes and identified potential quality issues.
INCOMING QUALITY ASSURANCE ANALYST 1/ TECHNICIAN
Amylin Pharmaceuticals/Bristol Meyers Squibb/ AstraZeneca Pharmaceuticals
09.2013 - 03.2018
- Used computer systems including SAP, MAXIMO, and LIMS Labware to manage inventory, supplies, and samples
- Guide others on Standard Operating Procedures and Work Instructions
- Read and interpreted diagrams, drawings and other schematics
- Identified temporary and permanent fixes to address issues and ensure compliance to regulatory standards
- Properly prepared and completed appropriate documentation using GMP documentation principles to ensure compliance to regulatory standards
- Executed validation protocols for processes and equipment
- Completed visual and dimensional inspections of incoming components using proper equipment
- Investigated and reported deviations in order to implement corrective and preventative actions
- Collaborated in data analysis and report creation on quality metrics and key performance indicators
- Checked and verified proper completion of documentation completed by coworkers
- Conducted raw material sampling and support of raw material receipt including active ingredient
- Ensure that weights, measures, and raw materials are managed appropriately so that manufactured batches contain proper ingredients and quantities
- Read, understood, and complied with good manufacturing procedures and standard operating procedures
- Revised and created procedures, forms, and standards to reflect current applicable specifications
- Tracked and analyzed product quality data to identify trends and insights.
- Reported problems and concerns to management
- Subject Matter Expert
Education
BACHELOR’S OF SCIENCE - Human Nutrition, With Business Minor
THE OHIO STATE UNIVERSITY
COLUMBUS, OHIOSkills
- Diagnose Problems
- Defect Investigations
- Production Data Review
- Quality Inspections
- Problem-Solving Skills
- Compliance with GMPs
- Quality System Implementation
- Verbal and Written Communication
Timeline
BULK / FORMULATION MECHANIC TECHNICIAN
AstraZeneca Pharma. /National Resilience, Inc.
04.2019 - Current
QUALITY ASSURANCE SPECIALIST
AstraZeneca Pharmaceuticals
04.2018 - 04.2019
INCOMING QUALITY ASSURANCE ANALYST 1/ TECHNICIAN
Amylin Pharmaceuticals/Bristol Meyers Squibb/ AstraZeneca Pharmaceuticals
09.2013 - 03.2018
BACHELOR’S OF SCIENCE - Human Nutrition, With Business Minor
THE OHIO STATE UNIVERSITY
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