Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting

Job Description

Discover Impactful Work:

Initiate and lead quality investigations in the Lab Operations - Analytical Operations (AO) and Development Operations (DO) including OOS and Unexpected results investigations, and Deviations.

Day in the Life:

• Initiate and lead investigations and authors investigation reports in TrackWise.

• Provide technical leadership on analytical investigations.

• Conduct investigations with input from AO/DO supervisor

• Direct Scientists in the performance of lab investigations.

• Interact with other departments (e.g., PPT, PM, QA), clients and with Subject Matter Experts (SMEs), as required, to thoroughly investigate incidents, conclusions, and appropriate Corrective Action Preventative Actions (CAPA).

• Ensure investigations are ready for approval and completed within required timeframes.

• Provide excellence in data integrity and Good Manufacturing Practice (GMP)/procedural compliance

• Design and facilitate effective CAPA actions. Owns CAPA actions as needed.

• Challenge the department on quality issues and system improvements.

• Maintain a safe working environment and report potential hazards.

• Perform alternating or rotating shift work (if required)

Keys to Success:

Education:

Bachelor of Science in Chemistry or related science.

Experience:

Minimum 5 years analytical chemistry experience within the pharmaceutical industry

Previous experience leading a team.

Previous experience in providing client service in the contract pharmaceutical industry

Previous method validation and product stability testing/reporting experience in the pharmaceutical industry.

Previous investigation experience in the Good Manufacturing Practices (GMP) analytical laboratory environment.

Equivalency*:*

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities**:**

Exceptional Good Manufacturing Practices, Good Laboratory Practices (GLP), International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) compliance knowledge. Strong interpersonal and communication skills (both oral and written). Superior problem solving and troubleshooting skills. Ability to carry out investigations in a non-threatening manner with lab operations staff and effectively interacts with internal and external suppliers and clients. Excellent organizational skills with proven ability to prioritize when timeline conflicts exist. Detail oriented. Ability to work well independently and in a team environment. Experience with Microsoft Office Applications. Proficiency in 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 odors, 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, respirator on occasionally.

Excellent Benefits

• Benefits & Total Rewards | Thermo Fisher Scientific
• 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 salary range estimated for this position based in Ontario is $69,400.00–$104,050.00.