Quality Assurance Associate

Job Title: Quality Assurance Associate

Location: Charlottetown, PE C1E 0A1, Canada

Duration: 12 Months – Possible Extensions

Schedule: Standard 1st Shift | Monday – Friday

Work Arrangement: On-site

Nature of Job: Contract

Pay Rate: $30.00–$35.00 per hour on W2

Job Type: Contract

Domain: Quality Assurance / Pharmaceutical / Food and Drug Manufacturing

Deadline: 11/20/2026

POSITION OVERVIEW:

The Quality Assurance Associate will support and execute activities within Quality Operations, Quality Systems, and Compliance. Key responsibilities include document control, change control, quality incidents, Corrective and Preventive Actions (CAPA), Good Manufacturing Practice (GMP) data review, batch record review for product release, internal and external audits, and supplier quality management.

The ideal candidate will have experience working in a food or pharmaceutical manufacturing environment, along with direct experience in a Quality Unit. This role ensures that manufacturing operations, quality systems, and compliance activities meet applicable GMP requirements and established Quality Management System (QMS) standards.

SKILLS REQUIRED

Primary Skills

• Quality Assurance in food or pharmaceutical manufacturing
• Good Manufacturing Practices (GMP)
• Quality Management Systems (QMS)
• Document Control and Change Control
• Quality Incident Management and Investigations
• Corrective and Preventive Actions (CAPA)
• Batch Record Review and Product Release
• Standard Operating Procedures (SOPs)
• Internal and External Audits
• Supplier Quality Management
• GMP Data Review and Compliance

Secondary Skills

• Deviation and Laboratory Investigation Management
• Out-of-Specification (OOS) Investigation Review
• Annual Product Review (APR)
• Quality Systems Review (QSR)
• Metrics and Scorecard Reporting
• Analytical Validation and Process Transfer
• Validation and Qualification Documentation
• Product Label Management
• Facility Inspections and Pest Control
• GMP Training and Documentation Archiving
• Communication, Critical Thinking, and Problem Solving

MAJOR JOB RESPONSIBILITIES

• Support quality incident programs, including deviations, laboratory investigations, complaints, and supplier-related incidents. Review incidents, assess severity, approve minor incidents and Phase 1 Out-of-Specification (OOS) investigation outcomes, and participate in major incident investigations.
• Participate in internal audits and support external and client audit requirements.
• Manage and lead changes to Standard Operating Procedures (SOPs) and review changes initiated by other departments through the change control process.
• Support the Annual Product Review (APR) program, metrics and scorecard reporting, and Quality Systems Review (QSR) activities.
• Monitor and enforce GMP requirements across all departments during daily operations.
• Support supplier quality management and supplier compliance activities.
• Inspect and release rooms and conduct facility inspections as part of general quality and compliance activities.
• Prepare or assist with reports, protocols, validation documents, and qualification documentation.
• Issue, verify, and archive Quality Control (QC) notebooks.
• Provide GMP and SOP training to employees across various departments.
• Manage product label masters and support product label creation.
• Support the CAPA program, including quality improvement and corrective action activities.
• Support analytical validation, process transfer, and analytical process lifecycle activities by reviewing and approving analytical validation data, protocols, reports, and work instructions.
• Participate in the pest control program, including inspections and investigations.
• Perform batch record and data reviews to support the release of critical raw materials, Active Pharmaceutical Ingredients (APIs), and finished products.
• Release critical raw materials, APIs, and finished products upon successful completion of the required BioVectra batch release training.
• Support the process lifecycle by reviewing and approving the creation and revision of batch records.
• Participate in SOP document lifecycle activities, including QA review and approval of SOP changes.

REQUIRED QUALIFICATIONS

• Post-secondary education is required.
• Three years of work experience with a food or pharmaceutical manufacturing company.
• At least one year of direct experience working in a Quality Unit position.
• Practical knowledge of GMP requirements and quality assurance processes.
• Experience with quality documentation, SOPs, investigations, and compliance activities.
• Strong written and verbal communication skills.
• Ability to work independently with minimal supervision and collaboratively within a team.
• Strong organizational, prioritization, and scheduling skills.
• Ability to review documentation accurately and maintain compliance with established quality standards.

Must-Have Requirements:

• Experience working with a food or drug manufacturing company.
• At least one year of direct experience in a Quality Unit position.

PREFERRED SKILLS

• A bachelor's degree in a scientific field is considered an asset.
• Experience with CAPA, deviations, OOS investigations, and change control.
• Familiarity with batch record review and the release of raw materials, APIs, and finished products.
• Experience supporting internal audits, external audits, and supplier quality programs.
• Strong critical-thinking and problem-solving abilities.
• Effective presentation and interpersonal skills.
• Ability to manage multiple priorities and meet deadlines.
• Strong attention to detail and commitment to quality and compliance.

BENEFITS

• Medical Insurance
• Dental Insurance
• Vision Insurance
• 401(k) Retirement Plan
• Paid Sick Leave
• Other applicable benefits, subject to employer and assignment eligibility.

AI USAGE POLICY

Artificial intelligence tools may be used to assist with administrative tasks and candidate screening. All hiring and selection decisions will be made by human recruiters and authorized hiring personnel.

EEOC COMPLIANCE

We are an equal opportunity employer and consider all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other status protected by applicable law. Employment decisions are based on qualifications, skills, experience, and business requirements.