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Quality Assurance Specialist
3 months ago
Apollo Health & Beauty Care is a leading developer of private label and control label health and beauty care products, recognized for its expertise in creating national brand-equivalent items that compete effectively with the most popular brands. As the largest private label personal care manufacturer in Canada, Apollo boasts extensive distribution in North America and serves clients across Central and South Asia, Mexico, Europe, and Asia. We are seeking a dedicated and proactive Quality Assurance Associate (12 Months Contract) to contribute to our quality assurance initiatives.
Role Summary
**This is a 12 months contract position**
The Quality Assurance Associate plays a vital role in achieving project milestones and supports various quality management activities, including Annual Product Reviews, Management of Deviations, CAPAs, Change Management, and SOP Management, all aimed at ensuring the quality of commercial products.
Key ResponsibilitiesPrepare APR reports according to the established schedule, compiling data from batch records, investigations, product modifications, and customer complaints.Collaborate with stakeholders to assess and manage Change Control Requests, ensuring adherence to GDP and change management protocols.Conduct internal audits to monitor compliance with the Quality Management System (QMS), including production, facilities, validation, and laboratory processes.Work with Quality colleagues to identify opportunities for continuous improvement within the QMS.Serve as a Subject Matter Expert (SME) in Quality Risk Management.Review deviation and investigation records, ensuring proper tracking, follow-up, and reporting/trending in line with GDP and deviation procedures.Evaluate Corrective and Preventative Actions (CAPA) for effectiveness, including tracking and reporting.Facilitate timely completion of Deviations, CAPA, Corrective Work Orders, Change Controls, and Investigations across departments.Assist the Quality Supervisor in reviewing batch records for product release.Create and maintain Quality Assurance and QMS standard operating procedures (SOPs).Oversee changes to controlled documents and systems, performing detailed impact analyses to ensure compliance with GMP and qualification requirements.Engage with cross-functional teams, including Quality Assurance, Manufacturing, Process Development, Facilities, and Regulatory Affairs, on quality assurance matters.Participate in cross-training with other QA Associates.Manage Logbook issuance, control, and review.Organize and maintain controlled documents.Qualifications:
Education and Experience: Minimum of 5 years of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing environments. A Bachelor's degree or diploma in Chemistry, Biology, Engineering, or a related field is required. Comprehensive knowledge of cGMP/GDP international regulatory compliance is essential, along with experience in a GMP setting.
Skills: Strong analytical abilities to prioritize tasks effectively in a fast-paced environment. Excellent written and verbal communication skills are necessary for successful performance in this role.
Problem Solving: The position requires a high degree of autonomy and involves regular analysis and recommendations for complex technical challenges.
Work Environment: The role is primarily office-based within a manufacturing setting, with occasional exposure to various environmental factors.
This job description is intended to provide a general overview of the responsibilities and qualifications for this position. It is not an exhaustive list of all duties and requirements. Apollo is committed to accommodating individuals with disabilities throughout the hiring process.
