Thermo Fisher Scientific→
Compliance Auditor at Thermo Fisher Scientific in Whitby, Ontario, CA
Skills
Job Description
Work Schedule Standard (Mon-Fri)
Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
Site Specific Information
Our Whitby Site specializes in commercial manufacturing for a full range of conventional dosage forms with specialized capabilities, and houses a fully integrated pharmaceutical development services (PDS) facility. Discover Impactful work: To conduct internal, external and client Good Manufacturing Practices (GMP) audits. Day in the Life:
Perform internal Good Manufacturing Practices audits of all departments as required and prepare written reports to document the findings.
Participate in the site Fit and Finish Audit.
Facilitate site preparations and execute audits for clients and regulatory inspections including regulatory awareness programs for each agency.
Assist with ongoing guidance and training of auditors (if applicable).
Assist with regulatory requests.
Manage Audit Observations and Audit CAPAs
Provide administrative support for ongoing Compliance projects.
Maintain a safe working environment and report potential hazards. **Keys to Success:*Education: Bachelor of Science (B.Sc.) in Chemistry, Biology, Pharmacy, or other related field*Experience:*Minimum 3 years of Good Manufacturing Practices /Good Lab Practices auditing experience in pharma/medical devices.Experience with SAP (an asset).Equivalency:*Equivalent combinations of education, training, and relevant work experience may be considered.**Knowledge, Skills, and Abilities:**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.**Physical Requirements:**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. Excellent Benefits
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
OTHER
- Relocation assistance is NOT provided.
- Must be legally authorized to work in Canada now or in the future, without sponsorship.
- Must be able to pass a comprehensive background check.
Compensation The estimated annualized pay range for this position in Ontario is $69,400.00–$104,050.00.