Compliance Associate

POSITION SUMMARY

Reporting to the Quality Assurance Manager, this position is responsible for ensuring that Solenis’s operations and policies comply with necessary regulations. This position will assist the London facility with creating and maintaining SOPs, ensuring the SOPs are trained as necessary. This position will assist with all audits; internal and external, compliance checks in Production, help investigate any Quality issues that arise in Production or in the lab.

Must actively participate and comply with our Health and Environmental program including training initiatives and following all policies and procedures. This position works in a team environment and is required to assist others as necessary.

• Employ safe work habits and complies with all applicable Diversey safety requirements
• Works closely with Quality Assurance, Plant Management, Production Teams, and QA Technicians at other plant sites
• Create, update, and maintain all SOPs for the plant. This includes working with all departments to ensure information is captured and documented properly.
• Help develop and maintain the ISO Training matrix to ensure the plant is compliant with ISO training
• Prepare Annual Product reviews for Drugs products to be compliant with Health Canada and FDA requirements
• Participates in all audits, and all prep work, FDA, HC, ISO, Halal, Kosher, etc. Will help gather information, SOPs, paperwork for the auditor during audits.
• Conduct Annual Health Canada GMP self-audit to be compliant with the Health Canada regulations.
• Perform GMP and ISO 9001 & ISO 14001 internal audits as scheduled
• Participate in daily QA lab activities as required, such as wet chemistry testing, positive releases, standard preparation and calculation, releasing raw materials for production etc.
• Responsible for internal micro water testing
• Review, inspect and authorize the release of DIN products (GMP) as well as perform routine stability testing on Plant manufactured goods and imported DIN products.
• Print & file various calibration reports, PMs, NA SOPs
• Train and assist Plant Personnel in the use and standardization of laboratory equipment and procedures in their departments
• Train new lab personal in procedures, product analysis and instrumentation use and maintenance
• Participate in continuous improvement activities such as 5 Why investigations, Kaizen, TPM
• Ability to change shifts to cover vacation and needs of the business
• Other duties as assigned

• Minimum
  
  Education Required:
  
  Bachelor’s in chemistry or related science with minor in Chemistry OR college equivalent education.
• Minimum Experience required: 1+ years of experience in a Quality Control environment within a GMP regulated facility. Experience with IR, UV/VIS, HPLC, and GC instruments.
• Working knowledge of computer applications such as email, MS office, SAP (a plus)

• Organizational
  
  Skills:
  
  Ability to work in a paced environment, multitask, to take and follow directions. Self Starter- takes initiative
• Adaptability:
  Adhere to changing priorities and deadlines. Can effectively cope with change; can shift gears comfortably.
• Safety Focused:
  Dedicated to the health and safety of yourself and your colleagues. Maintaining a safe and respectful work environment.
• Professional Communication
  
  Skills:
  
  Must communicate well with Diversey employees, visitors, vendors and customers
• Problem Solving:
  Analysis, problem solving and creativity.
• Attention to Detail:
  Must be able to complete accurate data and develop accurate written materials
• Teamwork: respectful, team player, collaborative
• Ability to work overtime, evenings and weekends where necessary.

We understand that candidates will not meet every single desired qualification. If your experience looks a little different from what we’ve identified and you think you can bring value to the role, we’d love to learn more about you.

At Solenis, we understand that our greatest asset is our people. That is why we offer competitive compensation, comprehensive benefits which include health, dental, vision and a defined contribution pension plan, and numerous opportunities for professional growth and development. So,…