Quality Control
Resume:
Pharaoh Accilien
South River NJ 08882
C: 732-***-****
E: ***************@*****.***
AREAS OF EXPERTISE
PROFESSIONAL PROFILE
Quality Management
•
Innovative quality professional with over 8 years of experience in
Device Management
•
both tissue banking and medical device. In-depth knowledge of
Process improvement
• quality management and regulations to develop and apply effective
Process Validation
• quality control processes and structures, Process Validations (IQ,
Statistical Process
• OQ, PQ), and SPC (Cpk and Ppk studies). Strong background in
Control technical writing, quality investigations, CAPAs, and effectiveness
• Quality Assurance checks. Ability to effectively conduct Supplier and Internal audits
per ISO 13485 & ISO 14971. Proven customer service experience
Quality Control
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and problem-solving abilities. Results-oriented, decisive leader,
Change Control
•
with skills in developing process improvements, risk management,
Document Control
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lean manufacturing, and working as an enthusiastic team player.
• Regulatory Affairs
Quality Audits
•
• Quality reviews RELEVANT EXPERIENCE
• Operational effectiveness
Musculoskeletal Transplant Foundation
• Lean Manufacturing 2004 - Present
• Risk management PRODUCT QUALITY SPECIALIST
• Customer Complaint 4 Years
Handling Maintain all aspects of the department’s quality management to
•
• Project management ensure products are in compliance with all quality standards and
Business management
• regulations
Perform complaints investigation/risk analysis and conduct
•
periodic audits on the department quality system, report findings to
management, and ensure corrective actions are implemented
CAREER STATEMENT
Spearhead the Processing department quality training program
•
“I am proficient at utilizing
Develop SOP’s and other controlled documents, such as Work
•
the resulting data from my
Instructions, Flow Charts, Finished Good Specifications, Technical
investigations to determine
Statements, etc.
appropriate actions, identify
and resolve issues, and Assist in the maintenance of DHFs, DMRs, Tech Files, Software
•
develop strategies and
Verification and Validation (SW V&V), clinical trials, and 510k
procedures. A professional
submissions for all class II devices
attitude and the motivation to
tackle new challenges and Identified training needs and developed various training and
•
perform multiple tasks are
process improvement methods, technical product knowledge, and
among the qualities that I will
clinical applications for Operations and sales representatives/surgeons
bring to the table.”
interface, which helped reduce costs and increase revenue by 7%
- Pharaoh Accilien
Provide quality training to Operations management staff to ensure
•
PERSONAL SKILLS
Pharaoh Accilien 732-***-****
compliance with all quality standards and regulations
Solution orientated
• Interpreted customer, field information and ideas to develop new
Conceptual Thinking
products ($800K)
Problem solving and analysis
• Increased customer loyalty and market positioning by designing
Integrity
and applying a semi automated equipment and software that
Team player
accurately measures products, leading to a 27% profit margin for
Information seeking
that product line
Interpersonal skills
• Developed a validated method that prevents tissue rejection,
Presentation skills
resulting in a $400K savings
• Participate in the development of all sports related products
• Deliver presentations to an audience of manager level within the
business
PROFESSIONAL SKILLS • Serve as the department liaison in all quality and regulatory
meetings, including Sales & Operations Planning/Material
Microsoft PowerPoint
Review Board (S&OP/MRB) meetings
Microsoft Excel
•
Microsoft Outlook
•
Microsoft Project
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Microsoft Visio
• QUALITY CONTROL/QUALITY ASSURANCE ANALYST
Master Control
Cyber Query 3 Years
QAD
Reduced product rejection rate 60%, an action determined
•
Bersoft
following completion of a six month study using root cause analysis
Minitab
Served as the department liaison in Product Review Board,
•
Adobe Photoshop
Material Review Board and Sales & Operations Planning meetings
Info CAPA
Developed procedures, analytical methods, transfer and
•
ISO 13485
validation, and stability testing to ensure product compliance
ISO 90001
Responsible for monitoring and maintaining quality and
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ISO 14971
compliance targets.
21 CFR Part 820
Performed periodic audits on products quality to ensure high
•
21 CFR Part 1271
standards of quality, and supported all external quality system audit
SOR/98-282
activities
Applied Statistical Process Control (SPC) methodology to
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monitor all test results for performance accuracy
Performed trend analysis, gauge R&R studies, and all assigned
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quality control testing to include cell based potency assays for product
release
Maintained current knowledge in regulations and emerging new
•
regulations affecting quality performance and standard to ensure quality
systems, processes, procedures and training appropriately reflect
current global standards
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• TISSUE PROCESSOR
1 Year
Aseptically processed human tissue in an ISO Class 4
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environment for surgical implantation
Enforced all policies, procedures, directives and initiatives with
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regards to processing functions, including compliance with FDA,
AATB and ISO guidelines, while also providing ongoing clean room
training
Served as Operations Core Team Leader in a cross functional
•
team, accountable for the successful implementation of new
products/equipment
East Orange General Hospital 2000 –
2004
EMERGENCY MEDICAL TECHNICIAN
Demonstrated strong assessment, prioritization and decision
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making skills in efficiently delivering both life threatening and non life
threatening patient/victim basic life support
ACADEMIC QUALIFICATIONS
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Centenary College
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2013
Business Management MBA
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New Jersey City University
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2009
Biology BS
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• Certifications
Certified Quality Auditor, ASQ
Certified Tissue Bank Specialist, AATB
Certified Auditor/Lead Auditor for ISO 13485, Stat-A-Matrix, RAB
QSA
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Pharaoh Accilien 732-***-****
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