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Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Discover Impactful Work:

Initiate and lead Deviation Investigations in accordance with Regulatory and Corporate Quality Standards & Guidelines. Collaborate cross-functionally in support of the identification of the root cause for each assigned deviation investigation, obtain alignment on Corrective Action Preventative Action that addresses the root cause, and define appropriate Effectiveness Checks in support of ensuring the deviation does not recur. This position is also responsible for supporting the daily activities of the Investigation Team by providing guidance and direction when required in relation to Deviations Investigations, creation of CAPAs, and identification of Effectiveness Checks. Responsible for supporting during inspections as an SME, pulling deviation data from TrackWise for trending, the creation of trend reports, and the report out of metrics.

A Day in the Life:

• Accept Deviation Investigations in order to initiate and lead the investigation.

• Application of root cause analysis tools ensures a thorough investigation and identification of root cause.

• Create a deviation report (DR) in TrackWise and complete the required investigation within the required timeframe to support On Time Delivery

• Propose and assign Corrective Action Preventative Actions (CAPAs) to correct the issue and prevent recurrence.

• Propose and assign an appropriate Effectiveness Check (EC) to ensure the monitoring of effectiveness and prevent recurrence.

• Collaborate cross-functionally in support of the identification of accurate deviation investigation root cause, creation of robust CAPAs, and creation of appropriate ECs.

• Support the prioritization of the Deviation Investigations team to ensure regulatory requirements, client commitments, and site business needs are met.

• Support the training, coaching, and mentoring of the deviation investigation team members on the Investigation process in writing quality investigations and creation of appropriate CAPAs and ECs

• Attend client meetings as an investigations' representative to provide guidance and strategic approaches when required.

• Support Regulatory Inspections, Corporate Audits, and Client Audits specific to the Investigations team's functions. Talk to auditors during inspections to ensure information is provided in a timely, accurate, and complete manner.

• Support the facilitation of daily huddles and weekly review boards to drive the performance of investigations as required.

• Pull deviation investigation metrics and associated CAPA and EC metrics for trending and reporting key performance indicators as required.

• Removes barriers during investigations.

• Maintain a safe working environment and report potential hazards.

• Perform alternating or rotating shift work (as required).

Keys to Success:

Education and Experience

• B.Sc.in chemistry, biology, life sciences, or other related field required.

• 3+ years experience in deviation investigations in the pharmaceutical industry.

• Excellent interpersonal oral and written communication skills.

• Proficiency with the English language.

• Flexibility with schedule

Knowledge, Skills, Abilities

• Excellent interpersonal and leadership skills.

• Extensive understanding of Good Manufacturing Practices, Standard Operating Procedures and CAPA.

• Strong problem-solving skills (identifying and evaluating root cause and recommending corrective actions / preventative actions (CAPA).

• Excellent organizational skills with proven ability to prioritize when timeline conflicts exist.

• Detail oriented with a high degree of accuracy and thoroughness.

• 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 systems SOP's 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.

WORKING CONDITIONS:

• Physical Effort: There is little physical effort and fatigue. Walks, stands, lifts small objects and tools, and /or operates keyboard equipment for short duration.

• Physical Environment: Located in a comfortable indoor area. Any unpleasant conditions would be infrequent and of short duration.

• Sensory Attention: Regular need to attend closely to complex or subtle stimuli that require great diligence and attention for proper interpretation.

• Mental Stress: There is regular pressure from deadlines, production quotas, accuracy or similar demands.

Benefits:

We offer competitive remuneration, annual incentive plan bonus, healthcare, 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!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will gladly provide reasonable accommodations covered under the ADA.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.