Heather Heath

Heather Heath Email and Phone Number

Quality Systems Specialist III @ KINOVATE LIFE SCIENCES, INC
Vista, CA, US
Heather Heath's Location
Vista, California, United States, United States
About Heather Heath

Dedicated and resourceful Quality Assurance professional with over 10 years of experience in the Pharmaceutical and Medical Device industry.Expertise in preparing start up plasmid DNA manufacturing site for GMP readiness, supporting External Audits, writing Technical Documents, managing Supplier Quality Program, Leading Internal Audits, data review and training Quality Department in SAP.Currently continuing to develop and expand my career in Quality Systems and Supplier Quality. Strong background in Immunodiagnostic Assay Method Development and Laboratory Operations. Goal oriented and fast learner with a penchant for professional growth.

Heather Heath's Current Company Details
KINOVATE LIFE SCIENCES, INC

Kinovate Life Sciences, Inc

View
Quality Systems Specialist III
Vista, CA, US
Website:
bd.com
Employees:
30997
Heather Heath Work Experience Details
  • Kinovate Life Sciences, Inc
    Quality Systems Specialist Iii
    Kinovate Life Sciences, Inc
    Vista, Ca, Us
  • Bd
    Quality Assurance Specialist
    Bd Aug 2023 - Present
    Contributed and supported all Quality activities including laboratory data review, Quality event management, and completing Internal Audits for Combination Product testing. Identified gaps and areas for improvement for the QMS and for cGMP Compliance including Supplier Qualification.
  • Thermo Fisher Scientific
    Compliance Specialist Ii- Microbial Manufacturing Services
    Thermo Fisher Scientific Mar 2021 - Jul 2023
    Carlsbad, Ca
    Accountable for managing and evaluating supplier documents for compliance including Questionnaires and Quality Agreements. Accomplishments included becoming the Subject Matter Expert in Quality for SAP, leading Internal Audits, supporting External audits, providing SME testimony for External Audits, creating an Approved Supplier List and mastering eDMS, TrackWise and Kneat. Also, I have authored key documents including Internal Audits, Fit and Finish Inspections, Supplier Qualification and… Show more Accountable for managing and evaluating supplier documents for compliance including Questionnaires and Quality Agreements. Accomplishments included becoming the Subject Matter Expert in Quality for SAP, leading Internal Audits, supporting External audits, providing SME testimony for External Audits, creating an Approved Supplier List and mastering eDMS, TrackWise and Kneat. Also, I have authored key documents including Internal Audits, Fit and Finish Inspections, Supplier Qualification and Supplier Corrective Action (SCAR) SOPs. Show less
  • Green Running Events
    Owner
    Green Running Events Jul 2010 - Mar 2021
    Greater Los Angeles Area
    Founder and Race Director of the Eco 8k, an event featured in the SoCal USATF Cross Country Grand Prix yearly competitive running series. I was solely responsible for sponsorships, recruiting volunteers, marketing, logistics, race course planning, budgeting, fundraising and developing stakeholder relationships.
  • Takeda
    Quality Analyst
    Takeda Oct 2020 - Jan 2021
    Thousand Oaks, California, United States
    Reviewed and approved Manufacturing Batch records
  • Quantimetrix
    Technical Support Specialist- Quality Assurance/Regulatory Affairs
    Quantimetrix Jun 2018 - Aug 2019
    Redondo Beach Ca
    Chaired complaint meetings, prepared information/ data for product package inserts and technical updates, updated SOPs, wrote technical reports and issued Change Requests, resolved incoming technical inquiries and complaints, created project management timelines/charts, managed value assignment program. Investigated complaints and ensured resolution to deliver one time closure.
  • Sustainable Environmental Management Company (Semco)
    Managing Director
    Sustainable Environmental Management Company (Semco) Jan 2017 - Dec 2017
    Greater Los Angeles Area
    Oversaw contracts with 5 municipalities, wrote proposals, grants and reports, developed educational and outreach programs, prepared proposals for waste management companies, conducted research and created report for citywide Solid Waste Rate Study, managed used oil recycling programs and conducted site visits, created social media outreach content to promote environmental programs, developed grant applications for recycling programs.
  • Siemens Healthineers
    Laboratory Technician Iv
    Siemens Healthineers Oct 2015 - Aug 2016
    Greater Los Angeles Area
    Analyzed and modified raw materials for the manufacturing of allergen immunoassays and served as the Green Team chair for the Los Angeles site, executed complex batch records following GDPs and SOPs for biotinylation of allergens, HPLC (Waters & Hitachi Chromaster), Western blotting, SDS- PAGE, spectrophotometry, electrophoresis and BCA microplate assays, followed Quality Management System Standards and participated in audit preparation, planned successful and engaging employee events (Earth… Show more Analyzed and modified raw materials for the manufacturing of allergen immunoassays and served as the Green Team chair for the Los Angeles site, executed complex batch records following GDPs and SOPs for biotinylation of allergens, HPLC (Waters & Hitachi Chromaster), Western blotting, SDS- PAGE, spectrophotometry, electrophoresis and BCA microplate assays, followed Quality Management System Standards and participated in audit preparation, planned successful and engaging employee events (Earth Day, Diversity Day) that heightened awareness of the importance of resource sustainability among staff, led monthly meetings for Green Team Show less
  • Origin Oil
    Research Scientist
    Origin Oil Nov 2008 - Sep 2009
    Los Angeles
    Managed R&D algae laboratory including inventory and equipment, maintained algae cultures and performed analytical testing, researched algae strains and growth methods, implemented measures to improve recovery and decrease contamination, attended workshops and applied knowledge to improve operations
  • Siemens Healthcare
    Biochemist
    Siemens Healthcare 2001 - 2009
    Los Angeles Metropolitan Area

Heather Heath Education Details

Frequently Asked Questions about Heather Heath

What company does Heather Heath work for?

Heather Heath works for Kinovate Life Sciences, Inc

What is Heather Heath's role at the current company?

Heather Heath's current role is Quality Systems Specialist III.

What schools did Heather Heath attend?

Heather Heath attended California State Polytechnic University-Pomona, California State University, Northridge, Harcum College.

Who are Heather Heath's colleagues?

Heather Heath's colleagues are Gael Fernández, Juan Carlos Fregoso, Ashley Valdes, Rodolfo Navarro, Hilary Butler, Dave Mold, Roshan Rai.

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