Mary Howard
Henderson,NC
Summary
A dynamic and result driven professional who undertakes complex assignments, meets deadlines and delivers and produces quality work. I am a motivated and organized individual with proven ability in production, formulation, filling, assembly, and inspection. I have a well developed communication skills with a strong work ethic.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Filler Set Up Operator
Guerbet
06.2023 - Current
- Improved production efficiency by streamlining filler processes and implementing new techniques.
- Ensured a safe working environment by enforcing safety protocols and participating in regular hazard assessments.
- Maintained compliance with industry regulations and company policies during all stages of the filling process.
- Optimized filler machine performance with regular inspections, adjustments, and preventive maintenance tasks.
- Ensured accurate documentation of filler activities, including batch records, equipment logs, and shift reports.
- Enhanced product quality by adhering to strict sanitation guidelines and maintaining a clean work environment.
- Reduced product waste through careful monitoring of filling equipment and routine maintenance checks.
- Supported continuous improvement initiatives by identifying areas for potential process enhancements or cost savings measures in the filler operations.
- Addressed any equipment malfunctions quickly, minimizing downtime and ensuring timely completion of production runs.
- Increased team productivity by providing training on proper filler operation, safety protocols, and troubleshooting techniques.
- Streamlined changeover times between different products or packaging formats by developing efficient set-up procedures.
Quality Assurance Specialist
Corning Pharmaceutical Technologies
07.2021 - Current
- Responsible for adhering to safety rules
- Responsible for ensuring training is completed
- Create NCR's for defective products
- Review and approve GMP documentation and support Operations on Manufacturing floor
- Attend meetings in support of Operations
- Review and release batch records
- Have working knowledge of proper usage of all equipment in Quality lab
- Responsible for doing incoming inspection on products and releasing them in People soft
- Perform daily inspections on product ensuring it is defect free
- Performed measurements on product ensuring it is inspect according to company specs.
Operations Technician Clinical Trials
Catalent Pharma Solutions
02.2019 - 01.2021
- Safely operates equipment within a preparation area (i.e
- Cleaning, steamings, buffer/media prep, parts washing, autoclaving, etc)
- Clean and sterilize processing equipment using automated or manual systems
- Required to read, understand, and follow GMP documents
- Basic understanding on Operational Excellence concepts
- Responsible for ensuring cGMP compliance
- Ensures product is visually inspected to ensure quality requirements are thoroughly met
- Focuses on learning all equipment within work zone while maintaining high quality standards
- Ensures clarity and drive accuracy for processing and that areas of control are processing under GMP
- Set up and tear down of equipment
- 5 years of hands on experience with downstream manufacturing in a biopharmaceutical
- Strong background with chromatography, ultrafiltration, and diafiltration
- Becomes trained on basic processes and equipment and serves as a hands-on resource in Production
- Conducts all assigned activities in a safe and cGMP compliant manner
- Tasks will include, but are not limited to: Cleaning, preparing, and sterilizing production equipment
- Cleaning and disinfecting production rooms
- Assembly, set-up, and disassembly of production equipment
- Executing process steps according to defined SOPs and BPRs
- Documenting activities in accordance with cGMPs
- Handling biologically and chemically hazardous goods
- Interfacing with process automation systems
- Check and verify components
- Perform quality control duties, i.e
- Sampling of product and environment
- Clean/sanitize production and warehouse areas and equipment
- Maintain Manufacturing facilities by routine/non-routine cleanings
- (Daily, Weekly and Monthly Cleanings)
- Requires gowning qualifications
- Prepare, build and complete processing assemblies (Pars) for production
- Assist with preparation of solutions, including weigh outs of components and mixing/counting of materials
- Clean, organize and maintain process waste rooms/areas
- Discard process waste and clean drums as needed
- Maintain inhalation products on an automated fill line.
Quality Assurance Technician
K Flex
07.2018 - 08.2018
- Inspect components before assembly, analyze trial products during development, or test finished goods
- Examining materials and products to check for flaws and deviations from original specifications
- Perform in-house calibrations and schedule outside calibration services on specialized equipment or gages
- Assists in establishing and maintaining statistical techniques & applications
- Conducts studies on characteristics to determine appropriate dimensions to measure for SPC (if applicable)
- Participate in internal audits of quality system plan and procedures
- Participate in routine visual inspections.
Process Technician
Biomerieux
04.2015 - 10.2017
- Ability to read, write and understand complicated product documentation and standard operating procedures with attention to detail
- Follow Master Batch Records for the manufacturing and packaging
- Performs weight checks for incoming and dispensed materials ensuring compliance with established procedures
- Operates scales including set-up, verification, leveling and challenging
- Identify, report, and resolve quality issues
- Safely and in compliance with batch records and SOPs, set up, operate, and clean manufacturing and/or packaging equipment
- Clean and sanitize manufacturing rooms including walls, floors, and ceilings per SOPs
- Report accidents and unsafe conditions or unusual circumstances to supervisor
- Complete accurate and timely documentation
- Follow good documentation practices in accordance with GMP
- Assisting with lean continuous improvement projects
- Leading others in application of cGMPs for manufacturing documentation, facilities, and equipment in a biotechnology environment
- Demonstrating a commitment and leading others to maintain high standards of quality, cleanliness, and organization within the manufacturing environment
- Set up and break down of filler equipment making sure machine was ready to run production
- Did all sample checks on products making sure product was in compliance according to batch record
- Operate equipment within the validated parameters
- Perform 100% final inspection of units
- Label and package acceptable units
- Follow and maintain documentation records, accountability of solution and units throughout the production process.
Inspector Associate
Merck
04.2013 - 03.2014
- Inspecting oral solid dose product for various forms of defects and contamination
- Opened up and completed paper work for specific batch record and product
- Physically inspected vials for freezer induced cracks and documented findings in the batch record
- Worked closely with Quality for nonconforming product and other issues.
Lead Operator injection molding
Parker Hannifinn
04.2006 - 05.2012
- Responsible for clean rooms
- Trained all new hires on equipment
- Made sure product was prepped for shipping including all samples, and generated packing slips with included part name, part number and total amount shipped
- Used various gauges for ex
- Pin gauge, drop gauge, and go no go gauges
- Work to plan, analyze and control the quality of manufacturing processes
- Provide training to team members on relevant industry processes and equipment operations safety
- Continuously monitor all operations and processes to prevent and correct equipment malfunctions
- Helped mold tech change molds in various machines as needed for work order.
Education
Certification - Fundamentals of Biomanufacturing
BTEC NCSU
Raleigh, NC03.2021
Certification - Aseptic Gowning
BTEC NCSU
Raleigh, NC09.2015
GED - GED
Vance Granville Community College
Creedmoor, NC06.2010
Skills
- Clinical Trials
- Plastics Injection Molding
- Chromatography
- CGMP
- Manufacturing
- Quality Assurance
- Calibration
- Quality Inspection
- Laboratory Experience
- Clinical Research
- Aseptic (Less than 1 year)
- Auditing (2 years)
- CGMP (8 years)
- Confident (3 years)
- EDMS (Less than 1 year)
- Lock out tag out on equipment (3 years)
- 4 years in FDA regulated facility
- 4 years working in Pharmaceutical manufacturing (4 years)
- OSHA (4 years)
- Experience running heavy automated machinery using HMI's (4 years)
- Team Player
- Dependable
- Good documentation (9 years)
- Solid dose (1 year)
- Injection molding manufacturing (6 years)
- Team Lead (6 years)
- Quality Control
- Maintenance
- Assembly
- Machine Operator
- Packaging (1 year)
- Word
Certification
- Aseptic Gowning, Present, Received aseptic gowning certification from NCSU
- Fundamentals of Biomanufacturing, January 2021, Introduction to biological products. Expression systems and biotechnology. Cell separation - centrifugation. Chromatography. Viral clearance. Ultrafiltration / Diafiltration. Bulk filling
Highlights Of Qualifications
- 3 years working in FDA regulated facility
- Nine years in healthcare assistance to the elderly-.
- Six + years SOP, EDMS, and GMP clean-room protocol experience Six years SOP and CGMP medical
- Five + years SOP, and CGMP manufacturing
- Highly self-motivated and confident.
- Works well under pressure
- Proficient fluency in computer skills Six years' experience in automated Five years shipping/ receiving /inspection/auditing experience.
- Values quality, integrity, respect and mutual benefit.
- BTEC Aseptic gowning certification
- Ability to perform computer applications.
- 1 year solid dose experience
Assessments
- Filing & organization, Familiar, August 2019, Arranging and managing information or materials using a set of rules.
- Workplace safety, Proficient, December 2020, Using safe practices at work
- Following directions, Proficient, December 2020, Following multi-step instructions
- Basic mechanical knowledge, Familiar, May 2021, Understanding and applying mechanical concepts and processes
- Mechanical skills: Monitoring, Completed, May 2021, Understanding of machine dials, gauges, displays, and data charts
- Work style: Reliability, Proficient, December 2020, Tendency to be dependable and come to work
- Analyzing data, Familiar, December 2020, Interpreting and producing graphs, identifying trends, and drawing justifiable conclusions from data
Personal Information
- Title: PHARMACEUTICAL MANUFACTURING ASSOCIATE
- Work Permit: Authorized to work in the US for any employer
Timeline
Filler Set Up Operator
Guerbet
06.2023 - Current
Quality Assurance Specialist
Corning Pharmaceutical Technologies
07.2021 - Current
Operations Technician Clinical Trials
Catalent Pharma Solutions
02.2019 - 01.2021
Quality Assurance Technician
K Flex
07.2018 - 08.2018
Process Technician
Biomerieux
04.2015 - 10.2017
Inspector Associate
Merck
04.2013 - 03.2014
Lead Operator injection molding
Parker Hannifinn
04.2006 - 05.2012
Certification - Fundamentals of Biomanufacturing
BTEC NCSU
Certification - Aseptic Gowning
BTEC NCSU
GED - GED
Vance Granville Community College
- Aseptic Gowning, Present, Received aseptic gowning certification from NCSU
- Fundamentals of Biomanufacturing, January 2021, Introduction to biological products. Expression systems and biotechnology. Cell separation - centrifugation. Chromatography. Viral clearance. Ultrafiltration / Diafiltration. Bulk filling
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