Quality Assurance and Validation Specialist

**Job Description**:
This is an interview position. GENERAL SUMMARY To support and maintain Quality Management System (QMS) including the Validation Master Plan for FedEx Temperature Control network. Accountable for evaluating service, solving healthcare customers quality assurance issues and ensuring consistent monitoring and measurements as well as continues improvement of the network. To execute Temperature Control Quality functions employing knowledge including but not limited to current Good Manufacturing Practices (CGMPs), corporate policies and manuals, customer Standard Operating Procedures (SOPs) and all the applicable Health Canada (HC) regulations.

We’re looking for a **Quality Assurance & Validation Specialist** and we promise it’s a really fun role

You get to:

- Support and maintain the Quality Management System including the Validation Master Plan for FedEx Temperature Control network.
- Execute Temperature Control Quality functions employing knowledge including but not limited to current Good Manufacturing Practices (CGMPs), corporate policies and manuals, customer Standard Operating Procedures (SOPs) and all the applicable Health Canada (HC) regulations.
- Report monthly quality metrics developed for measuring key quality attributes in temperature control network.
- Lead development and implementation of Investigation/Corrective Action Preventive Action (CAPA) process, Change Control process, SOPs, Record retention, Preventative Maintenance and Calibration records using an advance knowledge of GMPs/Guidelines 0069.
- Lead Vendor and vehicle qualification acceptance criteria. Responsible for ensuring competency of vendor/sub-contractor involved with the Temperature-Controlled validated program.

**This job might be for you if you**:

- Provide administrative support regarding document control process and records.
- Ensure consistent procedures and methods are followed in the documentation of any activities performed in association with temperature controlled validated program.
- Provide support with auditing and compliance activities, including Health Canada and Customer requirements.
- Data analysis - KPIs, deviation reporting, data automation, data visualization and presentation, etc.

**And - we'd love if you’re really good at the below as well**:

- Prior experience working with a validation process.
- Highly analytical and technical mindset.
- Excellent communication skills, both written and verbal.
- Strong quantitative, analytical, research, planning & time management skills required.
- Strong presentation and organization skills.
- Thrive in team-based environments (across functions/departments) to provide value-added support to internal and external clients.

**So what do you need to do all of this? How about**
- Bachelor's degree in Sciences, pharmacy, chemistry, biology, engineering or related discipline required
- 4 years of industry related experience in Quality Assurance/Control or Regulatory Affairs
- Prior experience participating in validation studies **required**:

- Prior experience working within healthcare or transportation field **required**:

- Experience using a Quality Management System.
- Strong knowledge and understanding of GMPs, ISO QMS and Health Canada Regulations on transportation

**Some awesome perks to working at FedEx**:

- A competitive salary and incentives
- A progressive benefits programs, including health and dental coverage and pension plan
- A Career Investment Fund with up to $5k a year for programs or tuition reimbursement
- Strong Community Service programs including diverse volunteer, charity, and fundraising initiatives to give back to both local and global communities
- Discounted FedEx services, flights, hotels, entertainment and car rentals
- A fun and diverse team who voted FedEx a best employer and a great place to work (we aren’t just saying that, it’s actually true)

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**DISCLAIMER