Investigator - Lab Operations

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), No contact lens allowed; prescriptive glasses will be provided, Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Warehouse, Will work with hazardous/toxic materials

Job Description

How will you make an impact?

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

 

What will you do:

• 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.
• Provide and document adequate training sessions to highlight findings of investigations and their trending to prevent reoccurrence of events.
• 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 timeframe.
• Provide excellence in data integrity and Good Manufacturing Practice (GMP)/procedural compliance
• Design and facilitate effective CAPA actions. Own CAPA actions as needed.
• Challenge the department on quality issues and system improvements.
• Maintain a safe working environment and report potential hazards.​

 

How will you get here:

 

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 is an asset.

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 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, respirator on occasionally.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company savings plan, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation