Alvin Alvarez
Union City,CA
Summary
Highly-motivated employee with desire to take on new challenges. Strong worth ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
9
9
years of professional experience
Work History
Manufacturing Compliance Specialist
Boehringer Ingelheim Pharmaceuticals
Fremont
09.2021 - Current
- Works with cross-functional teams as necessary to identify root or most probable causes, assess potential impact, and identify necessary corrections and/or corrective/preventative actions.
- Performs fact-finding research by investigating, collecting and analyzing data and compiling in report format.
- Provides support to department by assisting with special assignments and projects.
- Creates and manages action plans to mitigate audit discoveries and compliance concerns.
Manufacturing Associate Downstream Purification Operations
Boehringer Ingelheim
Fremont, CA
06.2019 - 09.2021
- Follows established safety and environmental guidelines and procedures for all work performed
- Provides support to CI team to implement improved safety and production processes
- Designs and develops supplemental information to SOPs for implementation into training programs
- Proficiency in harvest/depth filtration, tangential flow filtration, integrity testing, buffer titration, and chromatography skid operations
- Executed equipment and cleaning validation protocols.
BioProcess Technician Downstream Purification Operations
Aerotek/Tailored Management/Genentech
South San Francisco, CA
04.2016 - 05.2019
- Responsible for producing bio-therapeutic medicine by interfacing with automated production systems and controls within a cGMP manufacturing environment while maintaining areas in a high state of inspection preparedness
- Proficient in large scale chromatography column assembly/disassembly, integrity testing, and packing/unpacking
- Operates production equipment for Cell Culture Purification that may include process monitoring, sampling, purification, formulation, and transfer
- Provided support to UOME Operations during Genentech B3 Shutdown
- Collaborate with DSPE and MTS to troubleshoot equipment and process issues.
Sterile Processing Technician Volunteer
Kaiser Permanente
Fremont, CA
10.2015 - 11.2015
- Decontaminated and sterilized medical supplies, equipment, and instruments
- Organized mismatched sets of trays, instruments, and medical equipment
- Sterilized medical/surgical supplies with EtO, steam, or Sterrad sterilization methods
- OSHA, AAMI, and ANSI compliant.
Education
Contra Costa Medical Career College
11.2015
Academy of Art University
01.2015
Skills
- Documents work according to cGMP and cGDP
- Proficient in SAP, LIMS Labware, and MES software
- Proficient in Adobe Photoshop, Lightroom, and Premiere software
- Demonstrates understanding and importance of sterile boundary theory and execution
- Ability to self sufficiently multi-task/Strong organizational 5S skills while maintaining compliance and safety
- Engrained quality and aseptic technique mindset
Timeline
Manufacturing Compliance Specialist
Boehringer Ingelheim Pharmaceuticals
09.2021 - Current
Manufacturing Associate Downstream Purification Operations
Boehringer Ingelheim
06.2019 - 09.2021
BioProcess Technician Downstream Purification Operations
Aerotek/Tailored Management/Genentech
04.2016 - 05.2019
Sterile Processing Technician Volunteer
Kaiser Permanente
10.2015 - 11.2015
Contra Costa Medical Career College
Academy of Art University