GENERAL DESCRIPTION:
The QA Technical Report Writer is responsible for creating, reviewing, and maintaining high-quality technical documentation that supports Quality Assurance (QA) and manufacturing processes. This role involves drafting detailed investigation reports, root cause analyses, CAPA documentation, risk assessments, and change control records, as well as reviewing and updating Standard Operating Procedures (SOPs) to ensure regulatory compliance and product quality. The position requires strong technical writing skills, analytical thinking, and collaboration with cross-functional teams to accurately translate complex technical data into clear, professional reports that support decision-making, continuous improvement, and regulatory requirements.
DUTIES/RESPONSIBILITIES:
- Create and manage technical investigation reports related to deviations, out-of-specification (OOS), and out-of-trend (OOT) results.
- Facilitate and document Root Cause Analysis (RCA) using structured methodologies (e.g., 5 Whys, Fishbone).
- Draft and support Corrective and Preventive Action (CAPA) documentation in collaboration with QA and manufacturing teams.
- Prepare risk assessments evaluating the effect of deviations, process changes, or other quality-related issues on product quality, safety, and regulatory compliance.
- Ensure accuracy, consistency, formatting, and version control of all QA documentation.
- Collaborate closely with Quality Assurance, Manufacturing, and Regulatory teams to capture technical information accurately and translate it into clear, professional reports.
- Assist with Change control documentation to support process or product changes.
- Assist with maintaining of Standard Operating Procedures (SOPs) to ensure current practices are accurately reflected
- Perform other duties as assigned in support of departmental and organizational goals.
QUALIFICATION REQUIREMENTS:
Education/Experience:
- Bachelor’s degree in chemistry, Cosmetic Science, Pharmaceutical Sciences, Biology, or a related scientific discipline.
- Minimum 2 years experience related field
Skills/Knowledge/Licenses:
- Comprehensive knowledge of cGMP‑regulated manufacturing environments.
- Familiarity with Health Canada and FDA regulatory requirements for OTC and cosmetic products.
- Proficient in Microsoft Office applications (Word, Excel, PowerPoint); experience with electronic Quality Management Systems (QMS) is 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
