Investigations Associate

pbuJob Description/u/b/pp/pdivdivpAs 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./pp/ppbHow will you make an impact?/bspan /span/p/divdivpspanspanInitiates and leads/coordinates the investigation and works with the /spanspanappropriate parties/spanspan related to Deviation Reports (DRs). The position will respond to both Packaging Processing deviations. /spanspanThis position is also responsible for trending issues, especially as it relates to gaps that are identified in root cause investigations./span/spanspan /span/p/divdivpspan /span/p/divdivpbspanWhat will you do?/spanspan /span/bspan /span/p/divdivullipspanspanI/spanspannitiate and lead /spanspanoperational/spanspan investigation/spanspans/spanspan /spanspaninto deviations /spanspanwith /spanspanappropriate /spanspancross/spanspan functional /spanspanparties./span/spanspan /span/p/lilipspanspanPerform root cause analysis /spanspanof deviations /spanspanthrough the use of RCA tools to identify/spanspan the /spanspanroot cause/spanspan./span/spanspan /span/p/lilipspanspanPerform technical writing of investigation/spanspans/spanspan./span/spanspan /span/p/lilipspanspanEvaluate the thoroughness of /spanspani/spanspannvestigation/spanspans/spanspan and determined root cause. /span/spanspan /span/p/lilipspanspanP/spanspanropose Corrective Action/spanspans/spanspan Preventative Action/spanspans/spanspan (CAPA/spanspans/spanspan)/spanspan to ensure root cause of investigations are addressed and prevent recurrence of the event/spanspan. /span/spanspan /span/p/lilipspanspanCollaborate cross functionally to support various documentation and training needs to ensure compliance /spanspanto/spanspan requirements/spanspan./span/spanspan /span/p/lilipspanspanT/spanspanrack, trend/spanspan,/spanspan and /spanspanmonitor/spanspan /spanspanmetrics for deviation /spanspaninvestigations/spanspan and related processes to /spanspanidentify/spanspan trends and /spanspanassociated /spanspanactions to /spanspanmitigate/spanspan risks and drive performance/spanspan./span/spanspan /span/p/lilipspanspanEnsure on time closure of assigned Investigations, CAPAs, Change Controls/spanspan./span/spanspan /span/p/lilipspanspanSupport/spanspan continuous improvement of /spanspanthe Investigation process /spanspanthrough Practical Process Improvement (PPI) concepts/spanspan./span/spanspan /span/p/lilipspanspanAssist/spanspan with regulatory / client audits as /spanspanrequired/spanspan./span/spanspan /span/p/lilipspanspanMaintains a safe working environment and reports potential hazards. /span/spanspan /span/p/lilipspanspanPerforms alternating or rotating shift work (as /spanspanrequired/spanspan)/span/spanspan /span/p/li/ul/div/divdivpspan /span/p/divdivpbHow will you get here?/b/p/divdivpspan /span/p/divdivpbspanEducation:/spanspan /span/bspan /span/p/divdivpspanspanCollege/Technical School diploma in pharmaceutical manufacturing, /spanspanscience/spanspan or related field./span/spanspan /span/p/divdivpspanspan /span/spanbr /bspanExperience:/spanspan /span/bspan /span/p/divdivpspanspanMinimum /spanspan3 years of manufacturing experience in pharmaceutical, food or cosmetic industry, with knowledge of batch packaging principles./span/spanspan /span/p/divdivpspanspanPrevious/spanspan experience in technical or scientific writing an asset./span/spanspan /span/p/divdivpspanspan /span/spanbr /bspanEquivalency/span/bispan:/spanspan /span/ispan /span/p/divdivpspanspanEquivalent combinations of education, training, and relevant work experience may be considered. /span/spanspan /span/p/divdivpspan /span/p/divdivpbspanKnowledge, /spanspanSkills,/spanspan and Abilities/spanspan:/span/bspan /span/p/divdivpspanspanStrong 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. /spanspanAbility to carry out investigations in a non-threatening manner with production staff and to effectively interact with internal and external suppliers and clients./spanspan Proficient Microsoft skills (Word, Excel, PowerPoint). /spanspanProficiency/spanspan with the English language (oral and written)./span/spanspan /span/p/divdivpspanspan /span/spanbr /bspanStandards and Expectations: /span/bspanspan /span/spanspan /span/p/divdivpspanspanFollow all Environmental Health Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental /spanspanobjectives/spanspan. Carry out all duties within strict compliance /spanspanto/spanspan quality /spanspanSOPs/spanspan and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. /spanspanActively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.)./spanspan /spanspanBe /spanspanclient and patient conscious at all times./spanspan /spanspanUnderstand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving./spanspan Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively /spanspanidentify/spanspan 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 /spanspanfield/spanspan. /span/span/pp/ppOur 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./ph2Apply today! http://jobs.thermofisher.com/h2/div