St-coordinator, QA Investigation

2 weeks ago

Richmond Hill, Canada Apotex Inc. Full time

**About Apotex Inc.**

**Job Summary**:
The Coordinator, QA Investigations is a member of the Quality Operations department, supporting product quality investigations, product release and product complaints teams.

**Responsibilities**:

- Quality Assurance In-Process: Assists with the following:

- Prepares trending and other reports to trend data
- Assists QA Coordinators in scheduling/conducting inspection/audits of the production/packaging area to ensure work is being done in compliance with all established standards
- Product Quality Investigations: Assists with the following:

- Performs initial review of investigations under the guidance of a QA Approver
- Prepares trending and other reports
- Product Release: Assists with the following:

- Assists QA Releaser in resolving documentation issues (i.e. incomplete information or missing documentation in batch records) that are impacting material disposition.
- Interacts with internal functional departments to obtain information to address customer requests
- Obtains approval and prepares documents for destruction or off-site storage.
- Product Complaints: Assists with the following:

- Receives Customer Complaint Reporting Form, performs an initial triage for criticality and missing, incomplete or erroneous information and enters details into the QMS
- Prepares and issues customer complaint acknowledgement letters and sample return
- Receives, distributes, logs and coordinates archiving of complaint samples.
- Works in a safe manner, collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.

**Job Requirements**:

- Education
- Must be enrolled in a recognized post-secondary Co-op education program, preferably in Science or related field.
- Knowledge, Skills and Abilities
- Good Oral and written English communication skills
- Able to interact and work in a team environment producing high quality work.
- Good organizational, time management and learning skills.
- Knowledge of Excel, Word, and other Microsoft Office Programs.
- Experience
- Not applicable.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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