Investigations Associate

2 weeks ago

Whitby, Canada Thermo Fisher Scientific Full time

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.

What will you do?

Initiate and lead operational investigationsinto 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 monitormetrics 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)

How will you get here?

Education:

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


Experience:

Minimum 3 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 non-threatening 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).


Standards and Expectations:

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to quality SOPs and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.).Be client and patient conscious at all times.Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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