1. AIDA MELENDEZ
18820 Green Bluff Dr. • Lake Oswego, OR • 503.344.6344 • aidap@comcast.net
1 | P a g e
SUMMARY OF QUALIFICATIONS
 A talented and skilled professional Chemist offering a proven career working within the pharmaceutical industry.
Incorporates expertise involving Laboratories Operations (Quality Assurance and In-Process Control),
Environmental Project Management, and Chemical Manufacturing Management.
 Advanced knowledge of Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Standard
Operating Procedures (SOP), Batch Records, 21 CFR Parts 210/211, and Regulatory Compliance including FDA,
OSHA, and EPA laws.
 An innate leader and manager who leads by example and who has demonstrated “hands-on” ability to manage,
motivate, train, and develop diverse employees, staff, and teams. Utilizes open communication, active listening
skills, and strength based development and training practices to engage and foster staff and team performance.
 Leverages bilingual fluency in English and Spanish combined with an ability to effectively communicate and
interacting, engaging, and collaborating seamlessly within all levels of an organization. Able to work in fast -paced
organizational environments, working well with diverse project teams and personnel.
 Takes initiative and relies on a solution-focused problem solving approach that mitigates and/or removes
challenging obstacles or roadblocks. Identifies opportunities to streamline practices that generate results without
compromising on the quality of work or project outcome. Recognized for an ability to improve processes, saving
an organization time, effort, and money.
 Organized and highly detailed approach in project management combined with the ability to work under deadline-
driven environments, consistently meeting project milestones and goals, on time and within budget.
 Newly acquired skills: Design Inputs & Outputs, Quality Systems & Risk Management (Product/Process FMEA,
Cause & Effect Analysis), 21 CFR Part 820, Validation Protocols, IQ/OQ/PQ, Lean Process, ISO 9001/13485,
Labeling, Methods of Separation for Proteins/Biomolecules (Filtration, Electrophoresis, Chromatography),
BioSafety Levels (BSL), Clean Room (Environment, Regulations & Gowning), Microbiological Control (Aseptic
Techniques, Viable & Non-Viable Particulate & Microbial Count)
AREAS OF EXPERTISE
 Manufacturing Operations & Logistics  Environmental Project Management
 Planning & Scheduling vs. Resources  Troubleshooting & Optimization
 Documentation & Reporting  Approval & Release of Material
 Leadership, Training, & Development  Budget & Capital Projects
 Laboratory Activities & Investigations  Corrective and Preventive Actions (CAPA)
 Good Manufacturing & Good Laboratory
Practices (cGMP, cGLP)
 Standard Operating Procedures & Batch
Records
 Federal Drug Administration (FDA), Codes and
Compliance
 Laboratory Facilities Remodeling &
Development
 Manufacturing Plant Performance & Product
(API)
 Safety/ Hygiene (OSHA) & Environmental
Protection Agency (EPA) regulations
EDUCATION, CERTIFICATION, & PROFESSIONAL DEVELOPMENT
 Bioscience Technology Certification, Portland Community College, Portland, OR, Completed: March 2015
o Certification Courses in Bioscience Technology Included:
 Applied Quality Practice, Exploring Bioscience, BioSeparations, Biotechnology Fundamentals,
Workplace Safety, Lab Math, Laboratory Techniques & Instrumentation, Quality Systems in
Bioscience
 Continued Education and Training, 2014 -2015
o Statistical Process Control, 16 hrs, Oregon Bioscience Association
o Project Management Fundamentals, 8hrs/0.7 CEU, Portland Community College
o Business Communication Fundamentals, 4hrs, Oregon Bioscience Association
o Overview of FDA Requirements for Regulated Industries, 4 hrs, Oregon Bioscience Association
o Bio Forum: Legacy Research Institute; Changes in Patent Laws affecting Bioscience Industry
o Forensic & Crime Laboratory Presentations & Tour; Vancouver, WA and Portland, OR
o Webinars and Speakers Presentations from recognized scientific organizations and industry. Among
topics: Tragic Chemical Accidents/Combustible Dust Hazards, Scrum, Accidents Investigations, Drug
Discovery Series, Purification of Proteins, Twisted Crystals, Pesticide Impacts on Pollinators, Rookie
Laboratory Mistakes; and others

2. AIDA MELENDEZ
18820 Green Bluff Dr. • Lake Oswego, OR • 503.344.6344 • aidap@comcast.net
2 | P a g e
 B.S. Science, Major Chemistry, University of Puerto Rico, San Juan, 1980
 Additional Continued Education and On-the-Job Training
o Basic Italian, Portland Community College, Portland, OR, Completed: March, 2015
o Basic Principles of Chemical Engineering (32 hours), Chicago, IL, 1996
o More than 500 hours of training including workshops and seminars offered by either company personnel
or a third party. Topics included, among others, RCRA (Resource Conservation and Recovery Act),
Cleaning Validation, Industrial Safety (OSHA), Good Manufacturing Practices (GMP), Modern Supervision
and Management Techniques, Safety & Hygiene in laboratories and plant manufacturing, and Train the
Trainers (Industrial/Manufacturing Operations Training Techniques).
 Medical Representative Basic Course, 1997
o 40 hours, Quality Medical Reps of Puerto Rico, San Juan, Puerto Rico
Curriculum covered Medical Representative basic functions, basics of pharmacology, medical
background on certain conditions, pharmaceutical marketing, product detailing, and product presentation
and communication skills.
 Beginners I Japanese Language, 1997 – 2000
o 130.5 hours, MACC Management and Communications Consultancy, Inc., Kobe, Japan
PROFESSIONAL OVERVIEW
Professional/Personal Sabbatical, 1997 - 2013
 Fulltime parent and continuous community volunteer.
 Managed all aspects of family household; overseeing logistics and finances.
 Spent time living abroad and adapting to a new culture, language, and developing a women’s social/sport’s group.
 Volunteered as a Girl Scouts Leader in both Japan and the U.S.
 Continuously volunteered within Elementary, Middle, and High Schools, supporting various academia related and
classroom tasks, sports events, and general office work.
Schering-Plough Operations, Puerto Rico, 1981 – 1997 (Consistently promoted throughout tenure with company)
Chemical Plant Manager, Bulk Antibiotic Manufacturing, 1995 - 1997
 Led all manufacturing activities for production of an antibiotic (API) to its final form as bulk powder.
o Chemical manufacturing process consisted of three major steps: Organic Chemistry synthesis,
specifically chemical reactions and their outcomes, Purification (Chromatography) including ion-exchange
columns, and product spray drying processes.
Environmental Project Manager, 1994 - 1995
 Led an environmental project looking for the optimal most cost-effective alternative for pre-treatment of two
antibiotics’ plant production by-products and discharge effluents.
 Managed a team of two chemical engineers involved with a collaborative technology search and experimental
design project and two laboratory technicians for hands-on experimental work.
Production Laboratories Head, 1987 - 1994
 Managed the 24/7 operations of two laboratories servicing In-Process Control for two API production plants and a
Fermentation Plant.
 Continuously monitored the manufacturing process reactions to ensure product was of optimal quality before
submission to Quality Assurance for final clearance to be used in a pharmaceutical product.
 Monitored and provided chemical mix alterations during the reaction chain process when there was a necessary
deviation step during chemical manufacturing.
 Performed and maintained all in-process analytical activity under a rigid timeframe in order to provide clearance
for manufacturing plant to proceed to next step.
Quality Assurance Analytical Laboratory Supervisor, 1984 - 1987
 Managed and monitored all activities related to the Quality Assurance release of Bulk substances (Steroids and
Antibiotics) and all related documentation. Process was initial step in creating final pharmaceutical product.
 Approved all incoming raw materials including polymers.
 Managed the GMP, GLP, and Safety & Hygiene in addition to staff training and development. Team was
comprised of seven Chemists as direct reports.

3. AIDA MELENDEZ
18820 Green Bluff Dr. • Lake Oswego, OR • 503.344.6344 • aidap@comcast.net
3 | P a g e
Quality Assurance Analytical Laboratory Chemist, 1981 - 1984
 Analyzed and tested all incoming materials including waters, raw materials, bulk substances, In-process, and
finished pharmaceutical products.
 Hands-on involvement with High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC)
instrumentation.
 Assigned as the “go-to” laboratory Technology Transfer Chemist to perform the majority of new products tests.
 Selected as Laboratory Head Chemist to perform more detailed testing or equipment troubleshooting when
necessary. Acted as chief decision maker for final batch disposition.
 Served as Laboratory’s Supervisor substitute when needed, performing all tasks including verification and
correction of laboratory reports and final disposition of batches.
Teaching Assistant, University of Puerto Rico, 1980 - 1981
 Taught two Organic Chemistry laboratory sessions for first year students of General Chemistry and Environmental
Chemistry.
 Prepared and taught the laboratory class based on the theme and experiment for the day.
 Instructed the specific experimental details and supervised a group of 20-25 students in each session for a period
of 3-4 hours of laboratory time.
 Prepared and administered the short test/quiz associated to the experimental work of the day. Corrected the short
test to distribute at the end of the laboratory period.
 Evaluated each student’s performance and submitted their grades for their academic record.
AFFILIATIONS & VOLUNTEER/COMMUNITY SERVICE
 Member of the Executive Committee and Co-chair of the Diversity Committee, American Chemical Society,
Portland Section, Portland, OR
 Member, American Chemical Society (ACS), Member #01510136
o Volunteer Judge, various school science fairs in Atlanta, Maryland, and Portland, 2015
o Presenter, National Chemistry Week, Family-oriented chemistry experiments, 2014
 Member, Oregon Bioscience Association (OBA), Portland, OR
 Member, American Society for Quality (ASQ), Member #65376293
 Member/Volunteer, Newcomers Welcome Club, Lake Oswego, OR
 Volunteer, Hispanic Translation Classes, Oregon Food Bank, Portland, OR
 Volunteer, St. Vincent De Paul Food Program, Portland, OR
 Volunteer, Lake Oswego Adult Center, Lake Oswego, OR
 Co-Leader/Mentor/Volunteer, Girls Scouts of America, Kobe, Japan Chapter and Alpharetta, GA, U.S. Chapter