Responsible for applying and maintaining quality standards for PCI Pharma Services and products. Responsible for the maintenance and performance of all quality management systems. Works closely with production and customer service to ensure customer specifications are met and comply with internal operating standards and regulatory standards (GMPs). Reports to the Quality Director. Consistently applies company SOP's relative to production, quality, and pharmaceutical standards Reviews and approves executed inspection and production-related documentation Guides, coaches, and directs production staff with respect to Quality issues and concerns using collaborative problem-solving skills Compiles and maintains QA documentation and data Consistently evaluates PCI quality control methods, policies, etc. Investigates customer complaints and provides a detail report to client outlining results of investigation Responsible for monitoring and adhering to GMP as well as Health and Safety QA Associate and/or Quality Director Conducts training on PCI's Quality Management Systems, processes and performs annual GMP refresher training Conducts environmental monitoring of Production Areas Assists Quality Director with external audits Assists with responses to external, internal, and Regulatory audit observations Undertakes quality control inspections, line clearances and line audits as required Approves material requisition forms for packaging, destruction, QA samples, rejects and any adjustments of pharmaceutical components and/or end use products Performs new product assessment to determine if new product (API) can be primary or secondary packaged at our site Lead, measure, and assess the procedures associated with the initiation and reporting of deviations, complaints,



self-inspections and CAPA's Initiate CAPA's resulting from deviations, customer complaints, identified non-conformances, audits, or any other means of problem identification Ensure resolution of corrective actions is accomplished in a timely manner using sound methods for root cause analysis, short term containment, and permanent solutions Ensures products and processes conform to SOPs, documented procedures, and expected quality levels Develop, monitor, and publish quality metrics that will accurately represent the performance levels as they relate to deviations, complaints, CAPA's, self-inspections Revise GMP documentation (SOP's, Forms, etc) via the change control system Develops test standards and procedures QA Associate Responsibilities and acts as a back-up to Sr. QA Associate and Quality Director as required Consistently applies company SOP's relative to production, quality, and pharmaceutical packaging. 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 GMP's. In-depth knowledge and experience with manufacturing and packaging processes. Exceptional attention to detail and accuracy in the maintenance of records and data. Extensive computer knowledge and adeptness with various software programs including Microsoft Word, Excel, Outlook and Database Management.



The ability to oversee project assignments, direct daily activities and provide on the job training to temporary employees. Attention to detail when utilizing the PC and data entering information. Requires a significant amount of walking and standing on a concrete floor. Works at a computer terminal for long periods of time entering and analyzing data. SUPERVISION Reports to the Quality Director. Works in climate-controlled office (70%) and warehouse and packaging rooms (30%). Works with frequent interruptions both in person and by telephone. The salary for this position is $59,840 -$67,320 CAD, with eligibility for an annual performance bonus. PCI provides full-time employees in Canada with a comprehensive and competitive benefits package, which includes paid time off, extended health perks (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. Join us and be part of building the bridge between life changing therapies and patients. 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: 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, marketi

📌 Quality Assurance Associate (Mississauga)
🏢 PCI TRGR Penn Pharmaceutical Services
📍 Mississauga