Data Entry Part-Time
Resume:
Theresa M Johnson
Concord, CA
******@*****.***
Highlight of Accomplishments
o Speaker for CWEA Bay Section-
Topic- Credentials Committee program for QSM professional digital badge system (May 2025) Topic- Management review process and document control processes to comply with TNI 2016. (May 2022) o Expanded testing capabilities at MAI since 2016 with accreditations to new standards and methods under CA ELAP, ORELAP, ISO 17025:2017, DOD in PFAS for Drinking water, Aqueous and Solids matrices, and Industrial Hygiene test offerings.
o Implemented growth in Chemistry with the retention of associates and cross training within the department for expanded test offerings at FGL, NAMSA, and currently with McCampbell Analytical Inc. o Worked with the engineers in the design and build in the expansion of the Chemistry Dept at NAMSA, FGL, & MAI. o Regulatory knowledge / experience with: EPA regulations for CA environmental testing labs, 40CFR141, 40CFR136, CA ELAP (CA regs, TNI 2016-2), ORELAP (TNI 2016), AIHA (ISO17025:2017), USDA Foreign Soil permit, CLIA licensing under Joint Commission, OSHA compliance for health & safety standards, 40Hr HAZWOPER certified, FDA (21CFR Part 11, 58, 210, 820, 1300 and others), cGMP, GLP, GCP and ISO (13485, 9001), NPDES permits and regulations for specific regulations within CA. EXPERIENCE
McCampbell Analytical, Inc. Pittsburg, CA
Director, QAQC & Lab Safety Feb 2016- Present
• Run the day-to-day operations within all aspects of the Quality Assurance/Quality Control (QA/QC) Program and all Lab Safety to comply with regulatory guidelines (DOD QSM, ISO, EPA, Standard Methods, NELAP, & ELAP under TNI 2016, and OSHA).
o Maintain compliance with being a fully compliant in TNI 2016 labs through ORELAP and/or third-party vendor assessments for tests requested.
o Achieved Lab Approval for testing under UCMR 5 (started Jan 2023) and successfully participated in PT studies and validation & participated in UCMR 4.
o Successfully opened and obtained a CLIA license and certification for SARS-CV2 testing in May 2020 and continued audit inspections through the Joint Commission standards and the CDPH for licensing and testing compliance until clinical was no longer needed for testing in early 2022.
• Developed, implemented, and continue to maintain a high functioning quality management system. Host all external regulatory, client audits / tours with new/ continuing certification. This includes open/closing meetings, initiating and responding to all inspection findings for the entire laboratory.
• Responsible for and maintain corrective action/ non conformances, SOPs, complaints, MDL/ validation studies, support equipment verification and calibration, instrument inventory control, control chart review, QA manual, Proficiency testing program, Internal Audits, for all methods accredited.
• Continually support and assist IT with specific testing criteria and functionality to ensure QC is met appropriately, implementing Qualtrax by end of Q1 2024.
• Oversee Inorganics and Micro Department as a Technical Advisor/subject matter expert for process testing improvement or client sample troubleshooting (ie BOD testing anomalies, sample matrix issues).
• Responsible for the EH&S Program maintaining safety as a priority for all staff and under waste permit per Contra Costa Haz Materials program (CUPA), hazardous waste disposal, audit inspections /responses, waste characterization/profiles. Provide safety training to the lab (general safety, respirator fit test, CPR/AED First Aid, Forklift).
• Responsible w Lab Mgr in personnel hiring/disciplinary action/termination/ annual reviews
• Implement and create more efficient workflows within the organization within all aspects of the laboratory.
• Provide annual training to employees to meet regulatory requirements or as needed (ie Data Integrity & Ethics Training accompanied by Computer Safety Awareness and Sexual Harassment training). BioScreen Testing Services (now ALS) Torrance, CA
Clinical Manager Oct 2015 - Jan 2016
• Responsible for the day-to-day Clinical Operations in the Los Angeles facility, including but not limited to: Cosmetic product testing for HRIPT, Primary Irritation, Ophthalmic studies, SPF Sunscreen testing, Anti-aging studies.
Theresa M Johnson
Concord, CA
******@*****.***
o Personnel management, budgeting, train/supervise research assistants/clinical coordinators. Perform annual GCP training for all Clinical staff at this location. Plan, develop, the safety and efficacy of research studies under the supervision of the Principal Investigator.
BioScreen Testing Services (now ALS) Torrance, CA
Quality Assurance Manager Sep 2010 - Sep 2015
• Responsible for the day-to-day operations within the QA Dept and Receiving Dept to comply with all applicable FDA guidelines, ISO9001, cGMP, GLP, GDP and GCP practices and ensure that all employees are trained. North American Science Associates Inc., NAMSA Northwood, Ohio Chemistry Dept Supervisor Dec 2007 - Sep 2010
• Maintained compliance with 21CFR Part 11, cGMP and GLP practices. ISO 13485 and ISO 17025 accreditation.
• Responsible for coordination of workload/projects, work schedules, hiring, budgeting for the dept, inventory control & establishing goals within the department. Expanded Chemistry lab in Aug. 2009 to increase space and efficiency
FGL Environmental and Agriculture Santa Paula, CA
Inorganic Department Supervisor Aug 2001- Nov 2007
• Responsible for coordinating department testing, revising SOPs per NELAP requirements, & project management. Participated in all audits, renewal of laboratory certification per ELAP, Dept of Energy and Client audits/tours.
• Performed Inorganic analysis using Standard Methods and EPA methods using Flow Injection Analysis for various analytes, wet chemistry techniques, and Ion Chromatography (IC) for various methods. Aquaria Group, Marineland Aquarium Products Moorpark, CA Laboratory technician Sep 1995 - Aug 2001
• Documented fish species and mortality rate performed various wet chemistry techniques/prepared. Education
• Bachelor of Science, Environmental Resource Management, California State University, Bakersfield
• Associate of Science, Environmental Sciences, Moorpark College Computer Knowledge
LIMS database(s) Microsoft Office (Outlook, Teams, PowerPoint, excel, word, etc) Track wise Program Crystal Report Program
Corel Cad 2016 Electronic Document System (Master Control, Compliant Pro, Qualtrax) Adobe Acrobat Pro/DC and Foxit Phantom
Continuing Education Courses
• Security Awareness of Hazardous Materials Training course, 2005
• Wastewater Treatment Plant Operation course, Cont. Education credit University of Sacramento, California, 2004
• FEMA course, Introduction to Hazardous Materials (CEU), 2016 Certifications
• Certified Lean Six Sigma Green Belt, 2016
• ISO 9001:2008 Lead Auditor Certified
• First Aid and Adult and Infant CPR certified, since 2000-current
• 40 HAZWOPER certified 2016-current (8hr refresher annually)
• Hazardous First Responder Awareness Trained (July 2023, annual refresher)
• Hazardous First Responder Operations Training (Jan 2024, annual refresher) Volunteer Services / Affiliations
• CERT Program Instructor and Youth Coordinator with the Community Emergency Response Team in Concord,CA 1st Teen CERT taught in High School following FEMA for disaster safety preparation Working with CalOES through Concord PD to bring CERT into High School curriculum for credits with Prgm Mgr
• Concord Police Dept Volunteer (VIPS) – Assist with community events and
• TNI Credentials Committee member (2023)
• Standard Methods Committee member - Joint Task Group (2019-current) various help on
• American Chemical Society member 2016- present
References and additional information per position available as requested.
Contact this candidate