Quality Engineer Project Manager
Resume:
Richard J. Aderman
Knoxville, Tennessee 37922
C: 770-***-****
***********@*****.***
Objective
To obtain a permanent full-time career position as a Quality or Process Engineering Professional.
Skills/Attributes Summary
25+ years experience in the pharmaceutical/medical device industry.
Strong Quality System Compliance (QSReg, 21CFR Part 810/820, ISO 9000 and 13485) experience.
Strong interpersonal communication skills.
Ability to apply and standardize quality principles across multiple sites.
Experience in supplier quality management.
Expert knowledge of validation as it applies to various types of equipment, manufacturing processes, packaging, stability testing, and clean rooms.
Ability to apply statistical techniques to problem solving.
Ability to manage as well as participate in project management.
Experienced in writing technical procedures.
Experienced in product transfer from R&D to manufacturing.
Specialties: Process validation, packaging validation, compliance, statistics, and people management.
Certified Green Belt, ASQ, 2004, 2011.
Certified Lean Champion, ASQ, 2004, 2011.
Certified Quality Engineer, ASQ, 2010.
Certified Quality Auditor, ASQ 2010.
Professional Work Experience
July 2015 - October 2016: Scapa Healthcare Knoxville, Tennessee
Project Manager /Validation Quality Engineer
Completed 2 DOE (designs of experiment) to reduce production scrap, improve production yield, and refine best practices for client production processes.
Assist plant management and make recommendations in determination of the need for validation and assist leadership team in quality regulatory or customer auditing.
Completed over 5 individual process validations, which included batch processing equipment, high speed production product in pouch/packet/blister packaging lines, high speed drug product labeling equipment.
Completed 3 validation projects for island dressing and vacuum drape negative pressure therapy products, this included, IQ, OQ, and PQ actions, allowed shipment of finished goods to meet product launch requirements and customer expectations.
Completed 8 CAPA investigations, improved the CAPA program to include effective corrective and preventative action steps, holistic training, and extensive follow up.
Completed 30 SCAR investigations, improved the SCAR (supplier corrective action) program to include vendor scorecards, robust incoming quality sampling plans, and raw material inspection plans with specific inspection test methods.
Completed 3 process FMEAs in ISO 5 cleanroom manufacturing process environments to identify all types of environmental contamination in cleanroom production environments, to reduce environmental contamination, reduce bioburden risks/hazards, and improve overall product quality.
Develop multiple and holistic product inspection plans, covering from raw material receipt through finished product testing and final product release prior to shipment.
January 2010 – July 2015: Johnson & Johnson Company, DePuySynthes – Horseheads, NY
Project Manager / Validation Quality Engineer
Manage the overall process validation program and perform oversight of validation activities for the entire plant, 3 shift operation ~400 employee facility, to ensure adequacy of validation activities and protocol documentation in terms of regulatory compliance and technical/statistical soundness.
Review, assess and evaluate, and approve ALL validation protocols (IQ, OQ, PQ) for compliance to procedures and regulations, statistical validity and approval (~30 monthly average).
Completed over 15 individual process validations, which included batch processing equipment, high speed production product in blister or packet/sleeve packaging lines, high speed drug product labeling equipment.
Provide guidance to others for the generation of clear, concise and defendable protocols and reports (over ~360 protocols annually).
Working knowledge in GAMP and 21CFR Part 11 compliance regulations, assist in determination of the need for validation.
Completed 12 CAPA investigations, improved the CAPA program to include effective corrective and preventative action steps, holistic training, and extensive follow up.
Assist plant management and make recommendations in determination of the need for validation and assist leadership team in regulatory or customer auditing.
Generate and/or maintain internal validation master plans (~45) as required for all special processes and new product launches.
Manage all special process validation activities for the facility that applies to Purified(RO/DI/WFI) water systems, non-sterile packaging, CER(control environment rooms), facilities air systems, chemical anodize, chemical passivation, and electropolishing chemical operations, plasma treatment, vibratory, bead blast, USC(ultrasonic cleaning), Vapor Degreasing, and Shot Peen processes.
January 2007 to January 2010: West Pharmaceuticals – Jersey Shore, PA
Project Manager / Senior Quality Engineer
Implemented Infinity QS SPC software program to improve all quality and production performance measures. The plant wide implementation included 12 platforms used across quality inspection and production operations for real time SPC monitoring. This was done on a 24/7 production operation, over four 12 hour shifts and for a plant size of 360 employees.
Developed plant metrics to measure % quality reject, % first pass reject, defects per million, % scrap, OEE, and % downtime to improve on these measures through continuous improvement activities.
Manage supplier validation activities including supplier assessment, protocol development, and generation of supplier validation master plan(s).
Completed 3 six sigma projects over the tenure to reduce scrap by 40% and increase production yield by 30%, resulting in $750,000+ in annualized savings.
Completed 2 CAPA investigations, improved the CAPA program to include effective corrective and preventative action steps, holistic training, and extensive follow up.
Performed and completed 10 or more OQ/PQ validations for plastic injection molding process validations.
February 2002 to January 2007: Pfizer Pharmaceuticals
Director of Quality Assurance & Analytical Services –
Direct reporting of 5 subordinate Chemists and 5 Quality Assurance individuals in the effort of managing the analytical laboratory, microbiological laboratory, quality assurance, quality control and product development function in quality programs NDA/ANDA development, projects, and submissions in product development of generic pharmaceutical drug products.
Managed the testing and release of all incoming raw materials per USP monograph.
Managed the testing of all production batch and in-process production batch testing, the testing and release of all incoming containers/closures for plastic and glass per USP monograph.
Performed process validations, analytical methods validation, cleaning validations on more than 15 different product formulas.
Performed a packaging conversion and accelerated stability for 30 different finished goods part numbers to reduce costs of materials.
Submitted three 510K submissions and write up, as well as, formal PMA process for medical device pre-market approval.
Approved and reviewed engineering drawings and specifications on product design control and production assemblies and sub-assemblies.
Monitored, managed, and approved 72 CAPA investigations during my tenure.
Performed 8 internal quality system audits, issues reports, and provided follow-up regarding corrective actions, including verification of effectiveness.
Managed and addressed over 140 documented finished product customer complaints.
April 1992 to February 2002: KIK Custom Products LLC: Technical Division
KIK Custom Products;
Quality Assurance/Technical Manager, 1999 - 2002
Direct reporting of 5 subordinate Chemists and 5 Quality Assurance individuals in the effort of managing the analytical laboratory, microbiological laboratory, quality assurance, quality control and product development function.
Completed over 23 individual laboratory process and analytical methods validations.
Completed over 65 individual process validations, which included batch processing equipment, high speed production packaging lines, high speed drug product labeling equipment, USP purified water systems, steam systems used for cleaning and sanitization processes.
Completed over 40 cleaning and sanitization process validations as well as drafted cleaning procedures for equipment and performed employee training.
Analytical Laboratory/Product Development Manager, 1996 - 1999
Direct reporting of 5 subordinate Chemists and 1 microbiologist in the effort of managing the analytical laboratory, microbiological laboratory, and product development laboratory function.
Completed over 23 individual laboratory process and analytical methods validations.
Senior Research Chemist/Process Engineer, 1992 - 1996
Perform chemical production evaluations, chemical processing development, and chemical manufacturing production scale up for finished product realization.
Education & Certification
Georgia Institute of Technology, Major: Chemical Engineering Minor: Chemistry
Bachelors of Science in Engineering, 1995.
Keller Graduate School of Management
Masters in Business Administration - MBA, Concentration Project Management, April 2003.
Current ASQ Member, 2013, 2014, 2015, 2016; Certified Green Belt, ASQ, 2004, 2011.
Certified Lean Champion, ASQ, 2004, 2011; Certified Quality Engineer, ASQ, 2010.
Certified Quality Auditor, ASQ 2010.
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