Quality Assurance Professional

Job Description

Job Summary:

• Conducts routine and non-routine analysis including but not limited to biochemical and chemical analysis of raw materials, in-process materials, and finished products according to established operating procedures.
• Compiles data for documentation of test procedures including stability program testing.
• Calibrates and maintains lab and analytical equipment.
• Participate in preparation of failure and complaint investigations, summaries and reports abnormalities.
• Revises and updates standard operating procedures as needed.
• May perform special projects on analytical and instrument problem solving, and develop testing and analysis methods and procedures in accordance with established guidelines.

Position Responsibilities:

• Test finished products for precision and performance.
• Analyse test results and prepare test batch records.
• Process and analyse data using basic statistical methods and internal software.
• Analyse in-line testing rotor lot data for lot release and issuing performance results.
• Support the company’s retention program, ensuring well organized storage of samples.
• Initiate, perform, and monitor stability studies and program in compliance with applicable regulations and proactively notify appropriate functional management of emerging issues.
• Test and release incoming raw materials (enzymes and reagents).
• Initiate and assist in resolving non-conformance related to QC inspection.
• Test, analyse and submit Proficiency Survey samples (CAP and API).
• Maintain equipment and lab supplies inventory.
• Support troubleshooting and assigned projects.
• Review instrument production logs, analyse and report abnormalities.
• Maintain current knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

Education and Experience:

• Bachelor of Science in Chemistry, Biochemistry, Biology or any other relevant scientific discipline with 2+ years of quality control and analytical laboratory experience.
• Experience with in-vitro diagnostics preferred.

Technical Skills and Competencies Required:

• Strong attention to details and numbers.
• Laboratory and technical competence including basic statistical analysis.
• Working knowledge of basic computer programs such as Microsoft Word, PowerPoint, Excel, and Outlook.
• Effective and clear written and communication skills
• Ability to perform routine responsibilities independently with minimal supervision
• Ability to complete tasks on time to keep commitments.
• Flexibility to prioritize and plan work activities.
• Deliver thorough, accurate, and complete work output with minimal errors and attention to detail.

Physical Requirements:

• This position will require fluent use of LIMS and IT tools, teleconferencing tools, as well as SharePoint technologies to share and manage information with Global QC Network and Quality Organization.
• This position will also require to lift or move materials weighing up to 50 lbs.
• This position regularly required to stand, walk and sit to perform the tasks.
• Specific vision ability required include depth perception and colour vision.