Quality Specialist

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.

**Job Summary**

Reporting to the Sr. Manager, Quality (3PL and QA Consulting), the Quality Specialist - (3PL and QA Consulting) provides support to the department in the management of quality operations.

**Responsibilities**
- Responsible for review of all batch release documentation and temperature data to support product release in Canada for MSD imported products/QA consulting clients, including MRA/non-MRA drugs and medical devices
- Review of stability protocols/reports, media fill studies, APQRs, and preparation of APQR addendums
- Responsible for review of receiving documents, scanning and submitting to clients, and final release in warehouse management system following release from client
- Main QA contact for clients assigned to him/her, and responsible for all GMP activities required to support client with ensuring GMP compliance
- Provide Quality Assurance guidance and support to potential new clients or new products as assigned
- Responsible for preparation and update of client manuals and client notes
- Provides support during audits as required
- Provides assistance with completion of complaint investigations, deviations, change controls, CAPA
- Prepares and updates SOPs and WIs as required
- Works on special QA projects, including Quality oversight for secondary packaging and labelling
- Supports other members of the team as needed
- Maintain relevant industry knowledge and completes required training as required
- Act as a McKesson ambassador of corporate values

**Minimum Requirements**
- Degree or equivalent and typically requires 4+ years of relevant experience

**Qualifications**
- Experience in Quality Assurance in the pharmaceutical industry or a similar role
- GMP training
- Ability to work independently and as a member of a team.
- Excellent written and verbal communication skills
- Able to manage multiple projects and deadlines
- Ability to identify compliance risks
- Excellent scientific knowledge
- Ability to interpret complex Regulatory documents such as Health Canada guidance documents in order to provide guidance to internal and external stakeholders
- Ability to multi-task and to work in a fast-paced environment
- Attention to detail
- Strong organizational skills
- Strong troubleshooting skills
- Strong time management skills

Career Level - IC - Professional - P3

At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at McKesson, please click here.

As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

**Our Base Pay Range for this position**:
$69,700 - $116,100

**McKesson is an Equal Opportunity employer.**

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