Quality Assurance - Pharmaceutical Sector

  • location: Brookhaven, PA
  • type: Permanent
  • salary: $70,000 - $80,000 per year
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job description

Quality Assurance - Pharmaceutical Sector

job summary:
Global Quality Manager

High volume U.S -based Global Solutions provider with corporate- owned branches world-wide, has a key opportunity in Philadelphia for their Quality- Pharmaceutical / Life Sciences Sector. This role will support the Philadelphia Facility, and will be the Subject Matter Expert in issues concerning quality, regulations, and shipment of goods worldwide.

RESPONSIBILITIES

** Oversee Packaging Strategies, Temperature Monitoring, Risk Management, and Transport Validation

** Set up internal training programs on Quality

** Responsible for collaborating with the decision and organizational layer of the Strategic Customer

  1. Initiate issue escalation to circumvent failures within the Logistics Branch
  2. Oversee and review quality issue reporting, resolution (CAPA) and follow up, including completion of Client Issue Reports and insure effectiveness checks are performed
  3. Assist Line Management and Quality with initial and continuous training
  4. Ensure local quality records are maintained in accordance with the QMS (quality reports, complaint information, relevant copies of audit reports, personnel training files)
  5. Archive management (procedures and timelines adhered to)
  6. Perform internal audits, assist with audit preparations, attend audits and complete audit reports and drive follow up and resolution as needed
  7. Support and/or lead customer audits, including preparation, attend audit execution and ensure that all related action items are resolved in a timely and accurate manner
  8. Assists in the evaluation and assessment of Marken-designated agents and/or out-sourced activities
  9. Assist with the collection of Key Performance Indicator (KPI) data and reporting and the production of KPI metrics to monitor and drive continuous improvement within the Branch
  10. Maintain general Quality, Health and Safety standards within the branch
  11. Define and execute training to improve understanding of and compliance with procedures and quality requirements
  12. Define and support initiatives to improve the performance of the branch
REQUIREMENTS:

Bachelor's degree or the equivalent combination of relevant education and professional experience.

2+ Years of relevant experience. Quality and Logistics experience preferred

Experience working in a GMP and GDP environment. Experience in the Pharmaceutical Sector is preferred

  • Experience from working in a compliance role, ideally with exposure to GDP and QMS environment
  • Experience in driving the daily workload and performance based on data (shipment/milestone reports, KPI matrix etc)
  • Experience with airfreight operations, import/export operations and related regulatory requirements (TSA, US CBP, FDA etc)
  • Driving win-win outcomes in situations of conflict, escalations and customer complaints
Skills:

  • Skilled trainer
  • Experience in driving the daily workload and performance based on data and performance KPIs (shipment/milestone reports, KPI matrix etc)
  • Expertise skills in defining and writing procedures and work instructions
  • Organized and a mind for paying attention to details
  • Structured and solution driven
  • COMPANY BENEFITS:
  • This company is one of the largest suppliers of supply chain solutions in the world. Excellent compensation plan including base salary, bonus, exceptional Medical/Dental,Vision insurance, 401K, Tuition Reimbusement, Paid Holidays, etc.

    If interested, please email me at: terri.miniutti@randstadusa.com
 
location: Brookhaven, Pennsylvania
job type: Permanent
salary: $70,000 - 80,000 per year
work hours: 8 to 5
education: No Degree Required
experience: 4 Years
 
responsibilities:
RESPONSIBILITIES

  1. Oversee and review quality issue reporting, resolution (CAPA) and follow up, including completion of Client Issue Reports and insure effectiveness checks are performed
  2. Assist Line Management and Quality with initial and continuous training
  3. Ensure local quality records are maintained in accordance with the QMS (quality reports, complaint information, relevant copies of audit reports, personnel training files)
  4. Archive management (procedures and timelines adhered to)
  5. Perform internal audits, assist with audit preparations, attend audits and complete audit reports and drive follow up and resolution as needed
  6. Support and/or lead customer audits, including preparation, attend audit execution and ensure that all related action items are resolved in a timely and accurate manner
  7. Assists in the evaluation and assessment of Marken-designated agents and/or out-sourced activities
  8. Assist with the collection of Key Performance Indicator (KPI) data and reporting and the production of KPI metrics to monitor and drive continuous improvement within the Branch
  9. Maintain general Quality, Health and Safety standards within the branch
  10. Define and execute training to improve understanding of and compliance with procedures and quality requirements
  11. Define and support initiatives to improve the performance of the branch
 
qualifications:
.

REQUIREMENTS:

Bachelor's degree or the equivalent combination of relevant education and professional experience.

2+ Years of relevant experience. Quality and Logistics experience preferred

Experience working in a GMP and GDP environment. Experience in the Pharmaceutical Sector is preferred

  • Experience from working in a compliance role, ideally with exposure to GDP and QMS environment
  • Experience in driving the daily workload and performance based on data (shipment/milestone reports, KPI matrix etc)
  • Experience with airfreight operations, import/export operations and related regulatory requirements (TSA, US CBP, FDA etc)
  • Driving win-win outcomes in situations of conflict, escalations and customer complaints
Skills:

  • Skilled trainer
  • Experience in driving the daily workload and performance based on data and performance KPIs (shipment/milestone reports, KPI matrix etc)
  • Expertise skills in defining and writing procedures and work instructions
  • Organized and a mind for paying attention to details
  • Structured and solution driven thinking
  • COMPANY BENEFITS:
  • This company is one of the largest suppliers of supply chain solutions in the world. Excellent compensation plan including base salary, bonus, exceptional Medical/Dental,Vision insurance, 401K, Tuition Reimbusement, Paid Holidays, etc.

    If interested, please email: terri.miniutti@randstadusa.com
 
skills: Qualification
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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