Investigations Associate

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Division/Site:

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:

Initiates and leads/coordinates the investigation and works with the appropriate parties related to Deviation Reports (DRs). The position will respond to both Packaging & Processing deviations. This position is also responsible for trending issues, especially as it relates to gaps that are identified in root cause

investigations.

Day in the Life:

• Initiate and lead operational investigations into deviations with appropriate cross functional parties.

• Perform root cause analysis of deviations through the use of RCA tools to identify the root cause.

• Perform technical writing of investigations.

• Evaluate the thoroughness of investigations and determined root cause.

• Propose Corrective Actions Preventative Actions (CAPAs) to ensure root cause of investigations are addressed and prevent recurrence of the event.

• Collaborate cross functionally to support various documentation and training needs to ensure compliance to requirements.

• Track, trend, and monitor metrics for deviation investigations and related processes to identify trends.

• and associated actions to mitigate risks and drive performance.

• Ensure on time closure of assigned Investigations, CAPAs, Change Controls.

• Support continuous improvement of the Investigation process through Practical Process Improvement (PPI) concepts.

• Assist with regulatory / client audits as required.

• Maintains a safe working environment and reports potential hazards.

• Performs alternating or rotating shift work (as required)

Keys to Success:

Education:

College/Technical School diploma in pharmaceutical manufacturing, science or related field.

Experience:

Minimum 2 years of manufacturing experience in pharmaceutical, food or cosmetic industry, with knowledge of batch packaging principles.

Previous experience in technical or scientific writing an asset.

Equivalency:

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

Knowledge, Skills, and Abilities:

Strong interpersonal skills. Understanding of Good Manufacturing Practices, Standard Operating Procedures and CAPA. Good organizational skills with proven ability to prioritize when timeline conflicts

exist. Ability to problem solve and troubleshoot. Ability to carry out investigations in a collaborative manner with production staff and to effectively interact with internal and external suppliers and clients.

Proficient Microsoft skills (Word, Excel, PowerPoint). Proficiency with the English language (oral and written).

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 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.

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

• Must be able to pass a comprehensive background check

Compensation

The estimated annualized pay range for this position in Ontario is $56,400.00–$84,600.00.