Clinical QA Coordinator

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Job Title: Clinical Quality Assurance Coordinator

Locations: Burlington, ON

Summary of Objective:
Responsible to provide administrative, documentation and training support to the Quality Team, ensuring that documentation is in compliance with all applicable regulations, Good Manufacturing Practices (GMPs), Standard Operating Procedures (SOPs).
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Manage precise and accurate filing systems.
• Document management for the department (i.e. SOPs, Certificates of Analysis (CofA's), Material Safety Data Sheets (MSDS), protocol files, packaging documentation) and arrange for off-site storage if required and destruction.
• Manages all employees' and temporary staff training records, identifying when retraining is required; maintaining training database (ZQMS).
• Change Control & Item Master Setup (IM) Management.
• Logistics Protocol Management.
• Deviations & Complaint Management.
• CAPA Log Management.
• Temperature Monitoring & Infitrak System Management.
• Vendor/Supplier Qualification Management.
• Provides assistance with audits - scheduling coordination, preparation of documentation, catering, etc.
• Responsible for verification of material issuance to packaging operations.
• Perform AQL inspections over packaged finished goods or incoming material, as required.
• Verifies copy issuance of batch documents prior to execution.
• Maintain QA Metrics spreadsheets.
• Back up for QC incoming inspections.
• Assists in packaging when requested.
• Provides administrative support to the department as required.
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position.
• Performs other duties as assigned by Manager/Supervisor.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Post-secondary education in quality or equivalent
• Minimum of 2 years' experience in quality control, preferable within the pharmaceutical or packaged goods industry
• Excellent communication skills (oral and written), including technical writing - Computer knowledge to use software programs such as Microsoft Office, proprietary software programs, internet navigation, ERP etc.
• Excellent time, project management, attention to detail and negotiation skills - Excellent interpersonal and organizational skills
• Ability to work with limited supervision

Preferred:

• Ability to display a willingness to make decisions.
• Ability to demonstrate attention to detail.
• Ability to hold oneself in a professional manner

The base salary hiring range for this position is ($36,608 – $39,582.4 CAD), with eligibility for an annual performance bonus. The final offer will be determined by a variety of factors, including but not limited to relevant experience, education, professional designations, specialized skills, and work location. This posting is for an existing vacancy currently open and available for hire.

PCI provides full-time employees in Canada with a comprehensive and competitive benefits package, which includes paid time off, extended health benefits (including dental and vision), life and disability insurance, and retirement savings options such as an RRSP with employer contributions. Additional wellness and employee-support programs may also be available.

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Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

This posting is for an existing vacancy currently open and available for hire.

At PCI, we do not use AI within our hiring practices.