pharmaceutical quality engineer project manager resume example with 6+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • Home: (555) 432-1000
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Professional Summary

Pharmaceutical industry Quality Engineer with diverse background and experience in strategic project planning and quality management. Results-oriented, decisive leader with proven track record of developing and implementing robust action plans and guidance to clients throughout the FDA submission and approval process. Self-motivated, high energy individual with strong interpersonal and organizational skills. Excel in dynamic environments while remaining pragmatic and focused Talented professional considered knowledgeable leader and dedicated problem solver. Brings 5 years of valuable expertise to forward company objectives. Attentive to detail with experience in coordinating projects, programs and improvements.

Core Competencies
  • Pharma company environment experience
  • Project management expertise
  • Proven track record of managing multiple projects at once
  • Cross functional leadership and collaboration
  • Effective and professional communicator
  • Emotional intelligence to 'read the room' and filter communications
  • Agile mindset to be able to shift priorities with ease
  • Project scheduling and controls
  • Change management
  • Ability to work remotely
Professional Experience
Precision Castparts CorporationWickliffe, OH,
  • Supported quality team members during corrective action updates.
  • Coordinated with quality control staff to complete inspections.
  • Contributed to root cause analysis to determine core reason for failures and errors.
  • Partnered with senior management to analyze issues and find appropriate solutions.
  • Provided standardization of GDP, Variance, and CAPA.
  • Developed and implemented comprehensive quality assurance program to guarantee organization products met safety and quality standards.
  • Recommended revisions to internal controls and operational and management policies and procedures.
  • Maintained compliance with industry standards and regulatory compliance during managed projects.
  • Escalated concerns about project and process quality, referring discovered issues to engineering manager for correction.
  • Led problem-solving activities to quickly identify and permanently resolve quality and productivity issues.
  • Facilitated process improvements to successfully decrease errors.
  • Established and tracked quality department goals and objectives.
  • Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
  • Collaborated with leads of all functional groups to establish integrated project plans for each study
  • Kept project teams informed, focused, and motivated to achieve short term and long term goals
  • Used strong analytical and problem-solving skills to develop effective solutions for challenging situations
  • Demonstrated respect, friendliness and willingness to help wherever needed
QUALITY SUPERVISOR , 08/2019 to 09/2020
AaipharmaWilmington, NC,

· Supervised Quality Assurance staff across 3 shifts.

· Oversees failure and discrepancy investigations and documenting investigations on process deviations.

· Developed and provided oversight to identification and implementation of appropriate corrective actions and preventive actions

· Periodically review records to verify that quality standards for each drug product is met

· Assisted in maintaining compliant controlled substance documentation specifically associated with sample handling and reconciliation

· Responsible for maintaining QA records associated with internal and external testing

· Assisted in developing policies and procedures related to QA· Ensured that all SOPs complied, reviewed, updated.

· Responsible for timely and accurate disposition of finished product to assure each batch meets specification prior to release

Trained personnel in proper sampling techniques, raw materials testing protocols and finished product inspection and testing strategies.

· Performed other duties or special projects as assigned by management

  • Developed and initiated standards and methods to fully inspect, test and evaluate materials and completed work Pharma industry settings.
QUALITY SPECIALIST , 01/2018 to 08/2019
Northwest HospitalOf, WA,

· Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.

· Maintenance of retained sample storage

· Evaluation of batches/product for compliance with defined specifications

· Sampling, inspection, and control of commercial product labels

· Final Sign off - of batches before quarantine

· Review and approval of shipping documentation for commercial products

  • Educated employees on specific QA standards and confirmed maintenance of standards.
  • Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
  • Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
  • Implemented process improvements to increase productivity in quality assurance operations.
  • Fixed identified issues to improve workflows.
  • Analyzed quality and performance data to support operational decision-making.
  • Reviewed production processes and identified potential quality issues.
  • Reported problems and concerns to management.
  • Developed and implemented procedures to meet product quality standards.
QA ANALYST, 05/2015 to 05/2017
EntegrisCity, STATE,

· Test various membrane materials (Raw, in-process and final product)

· Membrane Chemistry

· Fluid handling, liquid filtration

· Solution preparation using analytical balances, pH adjustments

· pH calibration, titration, F-7000 fluorescence calibration

· Analyze various membrane material using FTIR-ATR

· Documentation of test procedures into laboratory notebook per cGMP requirements

· Test incoming samples with IC (Ion chromatography), troubleshooting and maintenance

· Assist in the execution of validation protocols

· Troubleshooting of in-use instruments in the lab (F-7000, Optical Particle Counters)

· Trained new technicians on non-standard tests

· Scheduling of testing for laboratory technicians

· Data analyzing (raw data revision)

· Test incoming filter samples filled with DIW through HPLC

· Test incoming filters samples filled with HCL through ICPMS

Bachelor of Science: Public Health, Expected in 05/2020 to Rivier University - Nashua, NH,

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School Attended

  • Rivier University

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  • Bachelor of Science

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