GENERAL DESCRIPTION:
The Quality Assurance (QA) Technical Report Writer is responsible for preparing, reviewing, and maintaining accurate, comprehensive, and compliant technical documentation in support of Quality Assurance and manufacturing operations.
The role is primarily responsible for documenting and supporting quality investigations, including deviations, Out-of-Specification (OOS) and Out-of-Trend (OOT) results, Root Cause Analyses (RCA), Corrective and Preventive Actions (CAPA), risk assessments, and change controls. The position also supports the development, review, and revision of Standard Operating Procedures (SOPs) and other controlled quality documentation.
The QA Technical Report Writer works closely with Quality Assurance, Quality Control, Manufacturing, Technical Services, Engineering, and other cross-functional departments to gather and evaluate relevant information and translate technical findings into clear, concise, scientifically sound, and inspection-ready documentation.
This position requires strong technical writing and analytical skills, attention to detail, and a working knowledge of current Good Manufacturing Practices (cGMP) and applicable regulatory requirements.
DUTIES/RESPONSIBILITIES:
- Prepare and manage technical investigation reports associated with deviations, non-conformances, OOS results, OOT results, manufacturing discrepancies, and other quality events.
- Gather and evaluate relevant information including manufacturing records, laboratory data, equipment records, procedures, personnel interviews, historical trends, and other supporting documentation as required to support investigations.
- Facilitate and document Root Cause Analysis (RCA) activities using appropriate structured methodologies and other applicable investigation tools.
- Ensure investigations clearly identify the event, immediate actions taken, investigation activities performed, root cause or most probable cause, product and process impact, and required corrective and preventive actions.
- Draft and support Corrective and Preventive Action (CAPA) records in collaboration with Quality Assurance, Manufacturing, Quality Control, Technical Services, Engineering, and other applicable departments.
- Assist in establishing appropriate CAPA actions that address identified root causes and support the prevention of recurrence.
- Prepare documented risk assessments to evaluate the potential impact of deviations, discrepancies, process changes, equipment issues, or other quality events on product identity, strength, quality, purity, safety, efficacy, and regulatory compliance, as applicable.
- Support Change Control activities by preparing and reviewing documentation related to changes to products, processes, equipment, facilities, materials, specifications, test methods, procedures, and other controlled systems.
- Assist with the draft, review, revision, and maintenance of Standard Operating Procedures (SOPs), work instructions, forms, and other controlled documents to ensure they accurately reflect current practices and applicable regulatory requirements.
- Ensure technical reports and quality documentation are clear, accurate, complete, consistent, traceable, and appropriately supported by objective evidence.
- Ensure documentation complies with applicable Good Documentation Practices (GDP), cGMP requirements, internal procedures, and document control requirements.
- Support internal audits, customer audits, and regulatory inspections by assisting with the preparation, retrieval, and review of investigation reports, CAPAs, risk assessments, change controls, SOPs, and associated documentation.
- Assist with continuous improvement initiatives related to investigation quality, documentation practices, CAPA effectiveness, and Quality Management System (QMS) processes.
- Manage assigned investigations and documentation activities to ensure established timelines and departmental objectives are met.
- Perform other duties as assigned in support of Quality Assurance and organizational objectives.
QUALIFICATION REQUIREMENTS:
Education/Experience:
- Bachelor’s degree in Chemistry, Cosmetic Science, Pharmaceutical Sciences, Biology, Biochemistry, or another related scientific discipline. Minimum of 2 years of experience in Quality Assurance, Quality Control, pharmaceutical/cosmetic manufacturing, technical services, laboratory operations, or another related regulated environment.
- Previous experience preparing or reviewing deviations, investigations, CAPAs, risk assessments, change controls, or controlled technical documentation is preferred.
- Experience working within a pharmaceutical, OTC drug, Natural Health Product (NHP), cosmetic, or other cGMP-regulated manufacturing environment is considered an asset.
Skills/Knowledge/Licences:
- Comprehensive knowledge of cGMP‑regulated manufacturing environments.
- Familiarity with Health Canada and FDA regulatory requirements for OTC and cosmetic products.
- Strong technical writing skills with the ability to organize complex scientific and manufacturing information into clear, concise, logical, and professionally written reports.
- Proficient in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
- Experience with Quality Management Systems (QMS), Enterprise Resource Planning (ERP) systems, or electronic document management systems is considered an asset
- Excellent attention to detail with strong written communication skills in English.
- Well-developed analytical, organizational, and time-management abilities.
Job Types: Full-time, Permanent
Pay: From $24.00 per hour
Benefits:
- Casual dress
- Company pension
- Dental care
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Vision care
Work Location: In person
