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Quality Assurance Technician

Pharmaceutical Company – London Ontario

BLES Biochemicals Inc., www.BLESbiochem.com  seeks a QA Technician for their London location.  BLES Biochemicals Inc., is the market leader for pulmonary surfactant in Canada, and manufactures and distributes BLES^® (bovine lipid extract surfactant). BLES^® is a pulmonary surfactant for use in the treatment of premature infants suffering from Neonatal Respiratory Distress Syndrome. BLES Biochemicals Inc. is a privately owned Canadian controlled pharmaceutical company.

The QA Technician’s responsibilities include:

• Review and release executed batch production records (BPR) including equipment print outs and temperature charts, etc.
• Collaborate with Manufacturing and other departments to resolve product and process related quality issues to bring batch records to closure in a timely manner.
• Work closely with Manufacturing and other departments to assist them in implementing and maintaining GMP processes, procedures and documentation.
• Maintain Database and logbooks related to batch record review and write related annual summary reports.
• Write and/or assist with the preparation of periodic reports (EM, PSUR, YBPR, self-audits, stability)
• Review QC and Production logbooks for accuracy and compliance with GMP
• Ensure deviations and OOS are adequately investigated and documented.
• Writing, reviewing, and leading deviation investigations, change controls, CAPA, non-conformance, OOS, etc.
• Provide technical guidance to Quality Assurance, Manufacturing, and suppliers of raw materials or finished products based on drug product specific requirements.
• Identify and solve product and process problems and supports various operational groups.
• Review manufacturing materials as required
• Write and review SOPs relevant to Quality systems.
• Perform all work in a GXP compliant manner.
• Perform all work in a safe manner.
• Carry out related tasks as requested by the QA/QC Manager or the Board.

If you have:

• A BSc. or higher in Biochemistry, Chemistry, Microbiology or related science
• 2+ years Quality Assurance experience in Batch Record Review
• Knowledge of good manufacturing practices and proper laboratory documentation
• Ability to share knowledge and experience with team members
• Strong technical writing skills with working knowledge of Microsoft office programs
• Strong written and verbal communication skills.
• Ability to work as part of a team to accomplish specific goals.
• Strong analytic and problem-solving skills.
• Excellent attention to detail.
• Good data analysis/manipulation skills (e.g. Microsoft Excel)
• Knowledge of good manufacturing practices and good documentation practices

And are willing to roll up your sleeves and take on any challenge to help this company continue to produce world class product, work with a great team, and receive a competitive compensation package then we would like to talk to you. Please reply in confidence, quoting QA Technician, BLES, to our HR Advisor, Rob Hiscox, Managing Director, The Tarran Group rob@thetarrangroup.com.

BLES Biochemicals welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.

We will respond to all applicants.