QA Associate

3 days ago

Concord, Canada Rubicon Research Full time

**POSITION PROFILE**

**Title**:QA Associate

**Reports to**: Sr. Manager - Quality Assurance

This position supports the Senior Manager of Quality Assurance in ensuring compliance for analytical and formulation method development, as well as stability testing activities related to nasal spray products. The role primarily focuses on analytical data review, GxP compliance of electronic systems, and adherence to regulatory requirements.

**Job Function**
- Perform quality review of analytical data.
- Conduct audit trail reviews in Empower and other electronic systems.
- Review and release calibration and preventive maintenance (PM) documentation.
- Draft, review, and revise Standard Operating Procedures (SOPs).
- Support and review the execution of stability studies.
- Review and approve quality notifications, including deviations, investigations, and change controls.

**Key Responsibilities**
- Review analytical data packages from various tests (e.g., HPLC) for quality compliance.
- Oversee change control processes and review equipment qualification documentation.
- Review and approve laboratory deviations and investigations.
- Review and release calibration standards for lab instruments (e.g., weights, pipettes, thermometers).
- Coordinate calibration services with third-party providers when required.
- Maintain and manage monthly schedules for preventive maintenance and calibrations.
- Issue and track laboratory logbooks and notebooks to ensure accurate documentation.
- Ensure timely completion of personnel training and maintain certification records.
- Monitor and document out-of-service instruments and coordinate necessary repairs.
- Act as AQPIC (Alternate Qualified Person in Charge) for controlled substances.
- Support batch release activities.
- Assist with administrative tasks and other duties as assigned by the QA Manager.

**Skills and Qualifications**
- Bachelor’s degree in chemistry, Pharmaceutical Sciences, or a related discipline.
- Hands-on experience with HPLC testing and proficiency in Empower software is essential.
- Minimum of 5-8 years of experience in pharmaceutical QA/QC.
- Analytical data reviewing experience is preferred.
- Strong organizational skills, a proactive approach, and eagerness to learn.
- Excellent written and verbal communication skills.

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

Pay: $44,540.63-$65,838.76 per year

**Benefits**:

- Dental care
- Life insurance
- Paid time off
- Vision care

Schedule:

- 8 hour shift
- Monday to Friday
- Weekends as needed

**Experience**:

- Analytical Data Review: 5 years (required)

Work Location: In person

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