Production Safety and Quality Training Lead
Resume:
NOLAN C. SPEIGHTS
Perth Amboy, New Jersey 08861-4804
Phone: 732-***-****
Email: **********@*****.***
CERTIFICATIONS
Lean Sigma Six Yellow Belt
U.S. DOT Hazmat Regulations Certified
U.S. EPA RCRA Generator Hazmat Management Certified
United Academy Scissor Lift Certified
American Heart Association Heartsaver First Aid, CPR, AED Certified
PROFESSIONAL EXPERIENCE
CYTOSORBENTS MEDICAL - Princeton, NJ 06/18 – 07/2024 Production Safety and Quality Training Lead
Responsibilities Include:
Creation, distribution and storage of safety and training documentation for production.
Author documents related to gowning within controlled environments.
Determine safety levels of production activities and post necessary signage.
Responsible for conducting in-house audits for safety and 5S integrity.
Act as “Team Leader” on outside based training projects.
Maintain, distribute, store PPE and monitor usage.
Contributing member of the Spill and Emergency Response teams.
Senior Operations Associate
Senior Associate recognized companywide as a trainer and the leader in productivity in the area of filling of CYTOSORBENTS medical devices. Responsibilities also include observing and monitoring chemical reactions, gauges, recorders, and signals while making specified operating adjustments and complete laboratory notebooks accordingly.
CMIC CMO USA Cranbury, NJ 06/2014-09/2015
Production Associate II
GMP manufacturing of clinical and commercial solid dosage forms in a CMO (Contract Manufacturing Organization) for various clients. Responsible for the dispensing, mixing and granulation of each batch to meet the require specifications of each client. Ensure team has all necessary tools to perform the required processes correctly and efficiently.
•Direct the assembly of the fluid bed granulator and set the required operating parameters for each lot.
•Responsible for the calibration and setting the required parameters for all instruments (ph meters, floor scales, balances and fluid bed granulator.
•Reviewed all batch records to help reduce errors by manufacturing department.
•Responsible for the final reconciliation and accountability of all materials and the final finished product.
BLACK DIAMOND NETWORKS contract Bedford, OH 07/2012-10/2012 Consultant/OTF Quality Assurance
Provided expert oversight and auditing of operations on the production floor at Ben Venue Laboratories for aseptic operations: This involved four facilities totaling seven production lines. Provide support to production, quality, maintenance, and engineering for activities that may impact sterility assurance by serving in an oversight role and also a mentor/coaching role.
•Advise management of necessary process changes to improve performance of operators and equipment.
•Worked with Operators and Quality Assurance to improve batch records, process controls and training programs.
•Observe and monitor critical activities during all phases of the Equipment/Component Preparation and Decontamination operations to ensure proper techniques are employed.
DENDREON Morris Plains, NJ 10/2010 – 11/2011
Cell Processing Associate II
Aseptic GMP manufacturing of clinical and commercial human bio-therapeutics within an ISO 5, class 100 cleanroom environment.
•Review, evaluate and revise Standard Operating Procedures (SOPs), batch records, and other applicable documentation to comply with regulatory requirements and good manufacturing practices (GMPs).
•Assist the validation department in writing and executing applicable protocols affecting the single use manufacturing equipment or controlled environment.
MEDIMMUNE – Philadelphia, PA 11/2009 – 10/2010
Aseptic Manufacturing Specialist
•Aseptically produce, compound and fill 2009 H1N1 Campaign biopharmaceutical products.
•Operate analytical and sterilization equipment (i.e. scale and/or balance, autoclave, pH meter, environmental monitoring equipment).
•Responsible for the review of batch records and process documentation for compliance with FDA and GCP/GLP/GMP regulations.
EDUCATION
*Delaware State College – Dover, DE Communications (Journalism)
*Wesley College – Dover, DE Applied Communications
*Some undergraduate coursework completed.
Contact this candidate