CHRISTOPHER COLEMAN
147 Fellsway W, Medford,United States
Summary
Reliable and hardworking Quality Control /Assurance Specialist offering 25 years of Quality Control and Manufacturing experience. Detail-oriented and professional knowledgeable about compliance standards. Adheres strictly to documentation guidelines and reporting requirements. Sound decision-making and performance talents. Collaborates with groups or work independently with minimal supervision. Proficient in ERP software and MS Office.
Overview
29
29
years of professional experience
Work History
Quality Assurance Specialist
Vizgen
Waltham, MA
04.2023 - Current
- Review batch records for disposition of intermediate formulations and final products.
- Ensure proper labeling of final products according to customer requirements.
- Create Non Conformance reports for materials and procedures, recommend revisions to improve customer satisfaction
- Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues.
- Consulted with management and personnel to educate on QA standards.
- Maintained accurate records of all inspections conducted in accordance with company policies and procedures.
- Ensured proper labeling of containers according to customer requirements.
- Inspected finished products for conformance with established quality standards before release from the facility.
Quality Control Inspector
Integra LifeSciences
Boston, MA
04.2022 - 04.2024
- Sampled and tested incoming raw materials
- Inspect final product for release
- Train newly hired Quality Control personnel on current procedures
- Adhere to all safety and health procedures
- Identify and report problems with Quality Control documents and procedures
- Perform routine and dimensional inspection of medical devices to assure compliance with tolerances.
- Verified accuracy of product labels, including expiration dates and lot numbers.
Quality Control Inspector II
Sun Pharmaceutical Industries
Billerica, MA
03.2012 - 01.2022
- Inspected incoming raw materials for non-conforming items and notified suppliers of any discrepancies.
- Pulled samples for Stability pharmaceutical testing and incoming raw material testing
- Revised Quality SOP's and Material Specification documents
- Proofread patient insert, physician insert and all component labels for pharmaceutical packaging
- Requested Batch Records for incoming raw materials and components
- Saved 250K plus annually by completing all necessary tasks after losing 75 per cent of staff
- Distributed samples to Chemistry and Microbiology departments
- Performed in process checks for pharmaceutical packaging, pre- and post- line clearance
- Trained newly hired employees by explaining procedures, job duties and performance expectations
- Executed final product AQL inspection
- Implemented 5S in the sampling laboratory
- Performed environmental monitoring in biological safety cabinet
- Followed all health and safety procedures
- Evaluated first article samples against product drawings and customer requirements.
- Inspected incoming raw materials for non-conforming items and notified suppliers of any discrepancies.
Manufacturing Technician
Applied Biosystems
Bedford, MA
09.1995 - 09.2011
- Formulated and filled diagnostic reagents and substrates
- Proficient use of laboratory bench top equipment
- Participated in the implementation of SAP at site
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
- Adhered to applicable regulations, policies and procedures for safety and environmental compliance.
- Kept production logs and maintained job material inventory.
- Maintained proper laboratory stock levels.
- Performed production adjustments for quality and productivity.
Education
Biotechnology Manufacturing Certificate - Biotechnology Manufacturing
Minuteman Career & Technical High School
Lexington, MA09.1995
Skills
- AQL Inspection
- Keen Eye for Detail
- FDA Audit Participation
- Documentation and Recordkeeping
- Environmental Monitoring
- SAP and Netsuite ERP
- Trackwise
- MS Office
- Time Management
- Safety and Health Procedures
- Attention to Detail
- Dimensional Measurement
- Manual and Finger Dexterity
- Raw Materials Inspection and Testing
- Crown Fork Truck Certification
- Color Discrimination
- Product Launch Support
- Inventory Control
- Team Collaboration
- Materials Inspection
- Detail Oriented
- Sampling
- Finished Product Inspection
- Quality Assurance
- Problem-Solving Skills
- Issue Resolution
- Quality Management Systems
Timeline
Quality Assurance Specialist
Vizgen
04.2023 - Current
Quality Control Inspector
Integra LifeSciences
04.2022 - 04.2024
Quality Control Inspector II
Sun Pharmaceutical Industries
03.2012 - 01.2022
Manufacturing Technician
Applied Biosystems
09.1995 - 09.2011
Biotechnology Manufacturing Certificate - Biotechnology Manufacturing
Minuteman Career & Technical High School
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