Rachel Haley
Austin,TX
Summary
Have 14+ years of process engineer and quality engineer experience in pharmaceutical and nutraceutical environment. Worked in both development and manufacturing facilities. Extensive knowledge of investigations, current good manufacturing practices (cGMP), standard operating procedures (SOPs), facility audits, CAPAS, customer complaints, standard work, and continuous process improvement. Experience working independently as well as on a team. Communication skills with a wide variety of people.
Overview
16
16
years of professional experience
Work History
Quality Compliance Investigator
ICU Medical
Austin, TX
02.2020 - 02.2021
- Investigated process deviations and product issues.
- Worked closely with numerous groups in the company and interviewed process technicians to determine root cause and preventive and corrective actions.
- Wrote detailed reports summarizing findings of investigation.
- Stayed current on training and up to date on procedures required for conducting investigations.
Quality Engineer
Premier Research Labs
Austin , Texas
05.2018 - 02.2020
- In charge of product investigations. Investigated out of specification material results and performed root cause analysis and corrective and preventative actions.
- Implemented improvements to the investigation process by streamlining the process and procedures. Updated process to allow for material review and release prior to investigation being closed. This change prevented the completion of corrective actions from holding up material release.
- Identified the top root causes of investigations and implemented actions which resulted in reduction of investigations by 10%.
- Third party facility audits. Audited third party labs and treatment facilities to ensure they were following FDA guidelines. Generated reports of observations and sent to facilities.
- In charge of customer complaints. Investigate physiological as well as product appearance and packaging complaints. Determine root cause and implement corrective actions.
- Lead development of supplier qualification program. Evaluate and rate the risk level of raw material suppliers.
Process Engineer III
Pfizer Pharmaceuticals
Andover, Ma
08.2011 - 12.2016
- Worked in cell culture manufacturing facility that produced product for clinical trials as well as commercial product.
- Performed tech transfer cell culture operations: scaled up process from Pilot scale to manufacturing scale. Created processing bath records. Prepared and organized all equipment, filters, and solutions to be used.
- Helped investigations group when they were shorthanded.
- Contributed to numerous investigation teams for cell culture
- Wrote, updated, and followed SOPs and batch records.
- Real time review of batch records.
- Final review of batch records to ensure all calculations performed correctly, correct materials used and accounted for in inventory system, and documentation completed at time of performance.
- Addressed and resolved batch record issues with appropriate people.
- Lead for various projects and areas of suite. Included seed lab, seed bioreactor, production bioreactor, and harvest.
- Part of continuous improvement team to fix various issues. Improved design of piping and automation to ensure proper elimination of bacteria in harvest equipment.
- Headed the transfer process for sending material from the cell culture suite directly to the purification suite.
- Standard work
- Part of team that successfully brought in microfiltration skid and got it up and running. One of few people in group who had understanding and working knowledge of system.
Process Engineer II
Wyeth Biopharma
Andover, Ma
06.2005 - 03.2011
- Worked in pilot laboratory that produced products for animal studies and stability testing.
- Lead for multiple products. Responsible for organizing campaign and performing tech transfer.
- Performed tech transfer of the purification process from bench scale to Pilot scale. Planned and organized all equipment and solutions to be used. Created processing batch records.
- Executed various purification processes including chromatography and filtration.
- Performed chromatography steps for protein capture and impurity removal.
- Use various filtration methods including micro filtration, pad/pod filtration, ultrafiltration, and virus retaining filtration.
- Compared pilot data to bench sale to look for similarities/differences in scaling process.
- Wrote summary and investigation reports.
- Collaborate with various groups to relay information and present data.
- Took ownership of automated processing skids. Created automated recipes that reduced manual labor by 30%-40%
- Group expert on skids and recipe creation.
Education
Bachelor of Science - Biomedical Engineering
Trinity College
Skills
- Communication
- Collaboration and relationship building
- Leadership
- Investigations
- Procedure adherence
- Manufacturing
- Customer complaints
- Facility audits
Timeline
Quality Compliance Investigator
ICU Medical
02.2020 - 02.2021
Quality Engineer
Premier Research Labs
05.2018 - 02.2020
Process Engineer III
Pfizer Pharmaceuticals
08.2011 - 12.2016
Process Engineer II
Wyeth Biopharma
06.2005 - 03.2011
Bachelor of Science - Biomedical Engineering
Trinity College
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