Investigations Associate

Thermo Fisher Scientific•Whitby, ON

8d•CA$56,400 - CA$84,600•Onsite

About The Position

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. 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.

Requirements

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.
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).
Must be legally authorized to work in Canada
Must be able to pass a comprehensive background check

Nice To Haves

Previous experience in technical or scientific writing an asset.

Responsibilities

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)