Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Languages
Timeline
Generic

Elis Yamaris Camacho

Summary

  • Experienced quality professional in the biopharmaceutical industry with a proven track record of ensuring quality and compliance across various areas, including QC Laboratory and Manufacturing plants (Cell Culture and Microbial – Biologic / Biopharmaceuticals, Oral Solid Dosages). Skilled in introducing new products, implementing quality systems, validation, managing manufacturing deviations, maintaining data integrity, and conducting risk assessments. Played a key role during regulatory, corporate, and internal audits with no major observations reported under supervision. Diverse skills include customer service, project management, risk management, recruiting, risk-based analysis, decision making, and leadership. Accomplished quality professional with extensive experience in the biopharmaceutical industry. Proven track record of driving quality and compliance improvements, achieving a 10% enhancement in first pass quality over six months by revamping the Quality System Forum and Quality topics and deviation management across several buildings. Skilled in new product introductions, last experience with legacy Horizon Krystexxa technology transfer in which a high degree of uncertainty and risk mitigation was involved as well as experienced in product quality systems implementation, validation, and risk assessments. Instrumental in regulatory, corporate, and internal audits, ensuring zero critical observations during regulatory audits. Adept at team management, conflict resolution, and decision-making with a strong background in customer service, project management, and risk-based analysis.
  • Proven track record in leading teams and driving operational efficiency. Demonstrated ability to implement strategic initiatives that enhance productivity and foster growth. Known for utilizing strong leadership and communication skills to facilitate team collaboration and achieve organizational goals.

Overview

21
21
years of professional experience

Work History

Sr Manager Quality

Amgen Manufacturing Limited
01.2020 - Current
  • Company Overview: Bacterial biopharmaceutical plant
  • During this time at Amgen – Bacterial biopharmaceutical plant I have been able to consolidate the quality forums and deliver effective metrics showing current plant performance to management to take the necessary actions toward the improvement of quality and compliance of the building
  • I have also been appointed as a Quality lead for the new product introduction (NPI) for a biologic product, the first NPI after almost 10years for the building, working in a highly complex and uncertain environment after the Amgen acquisition of Horizon
  • Under my leadership, I have fostered a collaborative environment with the product development, manufacturing, engineering, laboratory among other teams, to ensure we can navigate uncertainty following current Amgen procedures, ensuring efficiency and effective response according to plan in accelerated technology transfer of 12 months
  • I have been able to manage and create new ways of doing things, such as ensuring appropriate controls for manufacturing until legal considerations of the new acquisition able Amgen to file a new product
  • I have led a quality team of 8 people, ensuring coverage for all shift and according to aggressive timelines without fail
  • Prior to NPI, I also implemented an automated form to manage triages on the floor and increase the amount of decision making at the floor in almost 40%, ensuring decisions are being taken at the right level, in an expedite manner, when feasible
  • Quality lead for plant audit readiness, and main quality contact during regulatory audit managing different roles during audits such as runner, audit contact among others
  • Bacterial biopharmaceutical plant

Sr Specialist Quality

Amgen Manufacturing Limited
05.2019 - 03.2020
  • Company Overview: Supply Chain Organization
  • Supply Chain Quality organization supporting supplier investigations
  • I have been the responsible to re-vamp the Supply Chain Triage forum, to be more efficient and consistent
  • Under my leadership, the meeting time was reduced from more than 1 hour, to one hour exactly, every day
  • I have also developed a Deviations Service Level agreement with the support areas and the team was able to monitor effectiveness
  • Under my tenure on Supply Chain, I was able to engage the Supplier Management organization in a more structured manner, to support daily warehouse/supply chain quality events
  • The roles were defined and responsibilities delineated for each team, using a standardized deployment of a Triage templates
  • Serve as a FAO (Functional Area Manager) for all AML Reserve program investigation, ensuring corrective actions identified were implemented and complied with company procedures and policies
  • Serve as a mentor for all new deviation owner, training them to ensure they could manage minor deviations efficiently
  • At least a 10% improvement was observed during the past 6 months for first pass quality
  • Participate in Supply Chain areas (Warehouse, Incoming and Inspection, Receiving, Transportation) mock audit and area audit readiness processes
  • Quality contact of Critical Major deviations
  • Supply Chain Organization

Sr Manager Quality

Amgen Manufacturing Limited
03.2014 - 05.2019
  • Responsible for the quality and compliance of the oral solid dosage manufacturing plant
  • Ensure the New Product introductions comply with all AMGEN quality and compliance policies, regulations and site procedures
  • Ensure the Plant Quality personnel support the oral solid dosage supply plan
  • Reviews and approves non conformances, validation protocols and reports, process summary reports, change controls, CAPAs, alarms, and other process deviation and reports
  • Lead the oral solid dosage quality systems forum to monitor the health of the quality records
  • Proven results with no critical observations during regulatory audits
  • Support AML1 IP during regulatory audits, PAI readiness walkthroughs, and audit responses, as assigned by quality management

Sr Manager Quality

Amgen Manufacturing Limited
10.2011 - 02.2014
  • Lead the Mammalian Cell Culture Bulk Plant quality systems forum to monitor the health of the quality records
  • Actively participate during the internal, corporate and regulatory audits
  • Lead the Change Control governance and quality systems forum for the plant
  • Develop and implement the internal audit program for the Mammalian Cell Culture plant

Quality Lead

Merck (Schering Plough)
08.2004 - 10.2011
  • Actively participate in the new product introduction, representing quality and compliance in the commercialization teams
  • Reviewer of the Market Application/New Drug Applications for new products
  • Evaluate post market changes for compliance and regulatory impact
  • Reviews and approve process, equipment, and utilities qualifications and reports
  • Quality Lead for the Merck commercialization platform, ensuring quality aspects were incorporated since the beginning / feasibility phases
  • Member of the site Validation Governance team
  • Part of the Schering Plough – Consent Decree team working to comply with all regulatory significant steps and working plan

Education

Industrial -

Bachelor of Science - Industrial Chemistry

University of Puerto Rico

Skills

  • Team player
  • Conflict Management
  • Quality Manufacturing experience
  • Process and equipment Validation and qualifications Management
  • Quality auditing experience
  • Strategic planning
  • Cross-functional team collaboration
  • Troubleshooting and problem resolution
  • Data-driven decision making
  • Cross-functional communication
  • Talent development

Accomplishments

  • Drive results for quality and compliance, achieving a 10% improvement in first pass quality over six months by revamping the Supply Chain Triage forum
  • Led a team of 7 to ensure quality and compliance, resulting in zero critical observations during several regulatory audits
  • Execute a new biologic molecule new product introduction up to process validation in less than 12 months, being recognized by senior management.

Languages

English
Native or Bilingual
Spanish
Native or Bilingual

Timeline

Sr Manager Quality

Amgen Manufacturing Limited
01.2020 - Current

Sr Specialist Quality

Amgen Manufacturing Limited
05.2019 - 03.2020

Sr Manager Quality

Amgen Manufacturing Limited
03.2014 - 05.2019

Sr Manager Quality

Amgen Manufacturing Limited
10.2011 - 02.2014

Quality Lead

Merck (Schering Plough)
08.2004 - 10.2011

Industrial -

Bachelor of Science - Industrial Chemistry

University of Puerto Rico

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Elis Yamaris Camacho