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QA Associate
PCI Pharma Services. Apply and maintain quality standards for PCI Pharma Services and its products .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality management systems, GMP compliance, and pharmaceutical packaging processes. Proficient in conducting quality inspections, managing CAPA procedures, and maintaining detailed QA documentation.
Highest-signal resume keywords
Quality Management SystemsGMP CompliancePharmaceutical Packaging ProcessesCAPA ProceduresQuality Control Inspections
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality ControlDeviation ReportingRoot-Cause AnalysisEnvironmental MonitoringData ManagementMathematical SkillsDocumentation ReviewInspection ApprovalQuality Metrics DevelopmentSOP Compliance
Soft Skills
Attention to DetailOrganizational SkillsInterpersonal SkillsProblem SolvingTeamwork
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft OutlookDatabase Management
Industry Keywords
Pharmaceutical IndustryGMP StandardsQuality AssuranceProduction SpecificationsOccupational Health and Safety
About the role
Key responsibilities & impact- Apply and maintain quality standards for PCI Pharma Services and its products
- Maintain and perform quality management systems
- Work with production and customer service to ensure customer specifications and internal and regulatory GMP standards are met
- Apply company SOPs related to production, quality, and pharmaceutical packaging
- Review and approve inspection and production documentation
- Guide, coach, and direct production staff on quality issues
- Compile and maintain QA documentation and data
- Evaluate quality-control methods and recommend improvements
- Prepare deviation and incident reports
- Investigate customer complaints and report results to clients
- Review IORFs and determine supporting documentation requirements
- Complete annual product assessments as required by clients
- Monitor and adhere to GMP and occupational health and safety practices
- Conduct quality-management-system and annual GMP refresher training
- Conduct environmental monitoring in production areas
- Investigate temperature and humidity excursions and perform weekly report assessments
- Assist with external audits and responses to audit observations
- Perform quality-control inspections, line clearances, and line audits
- Approve material requisition forms for packaging, destruction, QA samples, rejects, and product adjustments
- Assess new products and determine whether APIs can be packaged at the site
- Lead and assess deviation, complaint, self-inspection, and CAPA procedures
- Initiate and manage CAPAs using root-cause analysis, containment, and permanent solutions
- Communicate corrective-action status, results, and impacts to stakeholders
- Ensure products and processes conform to SOPs and documented procedures
- Develop, monitor, and publish quality metrics
- Assess procedures for compliance, identify gaps, and recommend improvements
- Manage retained-sample storage
- Revise GMP documentation through the change-control system
- Develop test standards and procedures
- Perform delegated Senior QA Associate responsibilities and back up the Senior QA Associate and Quality Director
- Report to the Quality Director
Requirements
What you’ll need- University degree / college certificate and 2–5 years of equivalent experience in the fields of math or science
- Experience in the pharmaceutical industry and knowledge of GMPs
- In-depth knowledge and experience with manufacturing and packaging processes
- Exceptional attention to detail and accuracy in maintaining records and data
- Excellent organizational and time management skills
- Effective interpersonal and teamwork skills
- Ability to problem solve, coach, influence, and negotiate at all levels within the organization
- Extensive computer knowledge and adeptness with Microsoft Word, Excel, Outlook, and database management
- Excellent mathematical, written, and oral communication skills
- Ability to oversee project assignments, direct daily activities, and provide on-the-job training to temporary employees
- Ability to multitask
- Ability to walk and stand significantly on a concrete floor and work at a computer terminal for long periods
- Ability to work in office, warehouse, and packaging-room environments
- Established work schedule based on production needs
Benefits
Comp & perks- Annual performance bonus eligibility
- Paid time off
- Extended health benefits, including dental and vision
- Life and disability insurance
- Retirement savings options such as an RRSP with employer contributions
- Wellness and employee-support programs may also be available
- Full-time employment