Qc Data Reviewer

7 days ago

SaintLaurent, Canada IntelGenx Corp Full time

The QC data reviewer / associate ensure integrity of review and corrections in compliance with GLP, SOP and study plans. Ensure that all relevant data is reviewed. Supports new and established product stability studies through scheduling, monitoring and direct interaction with the quality department. Prepare quality control documentation to include specification, SOP’s, deviation and investigation reports in appropriate format.

**Responsibilities**:

- Monitor completion of testing
- Perform daily QC data review (notebooks, logbooks, raw data in empower and all related document to testing)
- Data entry for daily certificate release
- Ensure that all reports and accompanying raw data are accurate
- Create stability specifications, protocols and reports
- Perform stability trending in support of existing stability studies
- Manage stability samples
- Create RM, FP and packaging specifications
- Prepare and send samples to the third party laboratory
- Prepare all documentation for external laboratory
- Maintain laboratory documentation and inventory
- Perform QC sample reception process
- Interact with quality and production
- Inform quality department for initiation of non conformance reports
- Other tasks, as required

**Job Job Requirements**:

- Bachelor’s Degree (BA/BS) required
- Major Subjects / Specialties: Chemistry/Biochemistry
- 2 years or more in Analytical Pharmaceutical industry
- Knowledge of GMP, GLP, Health Canada and FDA guidelines
- Previous experience working with ICH Stability requirements
- Previous experience with Empower software
- Ability to adapt to changes in assignments flexibility, and meet department deadlines
- Excellent communication skills, both verbal and written in English and French
- Proficient with MS Office programs

**Job Types**: Full-time, Permanent

**Benefits**:

- Dental care
- Disability insurance
- Extended health care
- Life insurance
- On-site parking

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday

Ability to commute/relocate:

- Saint-Laurent, QC: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's Degree (preferred)

Work Location: One location

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