Senior Investigations Associate
$69,400–$104,050 year
On-siteWhitby, Ontario, Canada
Job Summary
Conduct internal, external, and client Good Manufacturing Practices audits across all departments, preparing written reports to document findings. Facilitate site preparations and execute audits for clients and regulatory inspections, including regulatory awareness programs for each agency. Manage audit observations and CAPAs while assisting with ongoing guidance, training of auditors, and regulatory requests. Perform administrative support for compliance projects and maintain a safe working environment by reporting potential hazards. Adhere strictly to Patheon quality systems SOPs and GMP standards while collaborating with team members to improve workflow efficiency and identify areas for system improvement.
Required Qualifications
- Bachelor of Science (B.Sc.) in chemistry, biology, pharmacy, or other related field
- Minimum 3 years of Good Manufacturing Practices /Good Lab Practices auditing experience
- Experience with SAP (an asset)
- Exceptional Good Manufacturing Practices, GLP, and HPBI/FDA compliance knowledge
- Proficiency with the use of quality investigation tools – FMEA, Fishbone, etc.
- Familiarity with SFLMS
- Familiarity with managing GMP regulatory requests
- Detail-oriented and organized, with a high degree of accuracy and thoroughness
- Excellent organizational skills and ability to prioritize in a fast-paced environment
- Strong written and oral communication skills
- Works well and efficiently with limited supervision
- Demonstrated computer proficiency with Microsoft Office programs
- Proficiency with the English Language
- Follow all Environmental Health & Safety Policies and Procedures
- Carry out all duties within strict compliance with Patheon quality systems SOPs and Good Manufacturing Practices (GMP)
- Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engaging in problem-solving
- Models positive thinking and is open to change, motivating the team to adapt to shift priorities and new ways of working
- Proactively identify areas for improvement in the execution of procedures
- Communicate risks to timelines in a proactive manner
- Consistently strives to improve skills and knowledge in related field
- Light physical effort and fatigue
- Walks, sits or stands for limited periods
- May require occasional equipment operation including keyboard equipment
- Lifts light items for limited duration
- Typically located in a comfortable indoor area
- There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights
- Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, and respirator on occasionally
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