Daniel Twum Barima

Summary:

Location: Worcester, MA 01606.Accomplished Quality Control Technician with extensive experience in conducting routine and non-routine chemistry and microbiological analyses of raw materials, in-process formulations, and final products, all within the confines of a controlled clean room environment and while strictly following gowning and Personal Protective Equipment (PPE) protocols.

Proficient in adhering to Standard Operating Procedures (SOP) and Good Manufacturing Practices (GMP), ensuring precise execution of chemistry and microbiological analyses within controlled environments.

Experienced in working within clean room environments, following strict gowning and Personal Protective Equipment (PPE) protocols to maintain a safe and contamination-free workspace.

Skilled in the meticulous review and maintenance of manufacturing shop floor documentation and batch records to ensure compliance with established procedures, a vital aspect of quality control and manufacturing.

Demonstrates proficiency in operating and maintaining laboratory equipment essential for testing, calibration, and filtration, contributing to precise and reliable analytical processes.

Brings hands-on experience in the manufacturing sector, particularly in diagnostic medical device manufacturing, emphasizing the importance of quality control and safety protocols in the production process.

Education:

Sunayni Technical University

Bachelor's in construction technology

Skills:

Process operation

Investigation

Deviation

CAPA

SOPs

Preventive Maintenance

GMP, cGMP, GLP, GXP

Testing

Documentation

Batch Record

Non- conformance reports

Raw materials

Professional Experience:

Cytiva, Westborough, MA Oct 2020 - Currently

Quality Control Technician

Provide hands-on, technical support for the design, implementation, and improvement of processes, instrumentation, and equipment.

Conducting comprehensive chemistry analyses on raw materials, in-process formulations, and final products, ensuring adherence to established specifications.

Provide subject matter expertise for process and equipment-related critical events, such as process investigation, process deviations, change controls, and CAPA.

Sample products, conduct tests, record data, carry out statistical process control on process operations, and update production logs.

Create/implement CAPAs and Change Controls; develop SOPs, URS, and Preventive Maintenance documents.

Document change activities for forms, work instructions, SOPs, and process non-conformance reports.

Manage the sterilization process by reviewing and ensuring the product built is ready for sterile loads.

Proficiently applying regulatory standards, including Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) for documentation.

Testing and marking sure the pouch burst test is done daily and documented for used (Water Sampling, Pull Test)

Provide Line Quality Support by offering guidance on the manufacturing floor and documenting CAPA activities.

Work closely with other departments to facilitate actions and maintain compliance to the current systems for process change controls, CAPA, deviations, complaints, internal GxP audit observation

Provide in-process quality support, including inspection and document review.

Strictly follow cGMP, standard operating procedures (SOPs), and batch records.

Checking or ensuring that label samples are checked before printing the entire labels for any work order.

Testing and labeling of incoming raw materials

Skilled in the maintenance, calibration, and oversight of laboratory equipment, encompassing various instruments such as testing devices, pH meters, titration equipment, and filtration systems.

Proficient in testing and release of in-process samples, release samples, and raw materials using various laboratory instrumentation and techniques.

Led all product design related corrective and preventive actions (CAPAs). Ensured that CAPAs are completed in timely manner with root causes investigations and supported corrective actions that are commensurate to the risk of issue being corrected.

Consistently achieving precision in equipment calibration while executing aseptic techniques in strict compliance with Standard Operating Procedures (SOPs).

Execute batch record operations and complete associated forms and logbooks.

Responsible for Ph/Conductivity readings and calibration, glass washers, and autoclave.

Assembled, cleaned, and sterilized process equipment and monitored processes.

Review manufacturing shop floor documentation.

Prepare Quality Control methods, process validation, Statistical Process Control (SPC), and Process Yield/report.

Perform real-time review of manufacturing batch records.

Accessed Windows XP to utilize MS Office Word, Outlook, and Excel.

Review manufacturing shop floor documentation.

Web Industries, Marlborough, MA May 2020 – Oct 2020

Quality Technician

Perform required inspections, measurements, and testing of incoming parts, in-process assemblies, and finished products per established criteria and record results.

Communicate any discrepancies to the manager for corrective/preventive action(CAPA)

Utilize multi-sensor coordinate measuring systems (OGP, SNAP, and CMM) for various inspections.

Skilled in the use of WinSPC (Statistical Process Control) program for data analysis

Perform visual, dimensional, and Functional inspections using specific, gages, micrometres, and microscopes.

Actively participates in evaluation and defining CAPA/ action plan / Investigations & agrees with plan and its implementation time lines with applicable standards.

Indicate inspection status of components with assigned labels

Utilise quality tools and techniques to perform and document full root cause investigations, to evaluate and resolve quality issues, and to enhance continuous improvement

Maintain product identification and traceability and controlled non-conforming products in accordance with documented procedures(NCMR- non-conformance material report)

Cardiofocus, Marlborough, MA Jan 2019 – Apr 2020

Quality Control/Manufacturing Technician

Examined finished refurbished endoscope devices per established criteria

Assisted in the installation and testing of medical devices in the cleanroom

Laboratory tests include set time, color, pH, viscosity, specific gravity, hardness, torque testing, volumetric measurement, pipetting, tensile strength, % solids, gel time, dry time, cure time, and shelf life/stability testing

Documented change activities for forms, work instructions, and SOPs and Process non-conformance reports

Ensure the compliance of the product through testing as per specification, change management, stability studies, deviation, and investigation, OOS and market complaint systems.

Offered technical support and expertise for all externally manufactured products.

Responsible for the incoming, in-process and final inspection of medical device

Comply with and reinforced the requirements of standard operating procedure(SOP)

Inspected parts to ensure that they meet specific engineering instructions

Checked pass or fail outcomes using various optical imaging equipment.

Detail review of the Device History Record package and accuracy of records prior to release

Adhered to Good Manufacturing Practices (GMPs) and Standard Operating Procedures (SOPs).

Inspection and assembly under microscope

Test products to verify conformance.

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