About the job
Position - Software Quality & Compliance Investigator - Validation NC/CAPA
Location - Raritan, NJ
Duration - Full Time with Quantum
Job Description:
Leading, coordinating, conducting and documenting GxP process nonconformances that are caused by Computer System Failures/Issues
Fostering collaboration and teamwork across multiple functional teams and stakeholders
Working knowledge and understanding of SDLC principles, processes and tools
Utilizing formal Root Cause Methodologies to determine root cause
Authoring Quality Investigation Reports that clearly and succinctly describe the nonconformance/issue, explain its root cause, and document the corrective action plans designed to mitigate existing risks and prevent reoccurrence.
Analyzing evidences and artifacts that support investigation facts, conclusions and corrective action plans
Explaining/Defending Quality Investigation Reports and responding to internal/external auditor scrutiny
Reviewing & Communicating Quality Investigation trends and KPIs
Qualifications:
Requires Excellent:
Verbal Communication Skills to obtain and share investigation details with business, technical and compliance SMEs
Excellent Compliance Writing Skills to author GxP documents & artifacts that are scrutinized by internal and external auditors
Ability to ‘Connect the Dots’ to ensure investigation details and artifacts represent an accurate and complete summary of the nonconformance that can be confidently defended in audits
Investigational Skills to be able to ask good, pertinent questions in order to gather all necessary facts from cross-functional teams
Critical Thinking Skills to be able to challenge inaccurate or incomplete facts
Organizational Skills to manage large amounts of data, information and artifacts that are submitted from various functions and stakeholders
Project Management Skills to ensure critical Investigation milestones and timelines are met
People Skills to be able to work with cross-functional colleagues and stakeholders having various levels of understanding
Attention to Detail
Respect for Timelines and Sense of Urgency
Ability to escalate when necessary
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Raipur |Delhi :
Delhi | PAN-India |Goa :
Goa | Panaji |Gujarat :
Ahmedabad | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Solan |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |Kerala :
Kochi | Malappuram |Madhya Pradesh :
Indore |Maharashtra :
Amravati | Aurangabad | Kolhapur | Mumbai | Nagpur | Navi Mumbai | Pune | Shirpur | Tarapur | Thane |PAN-India :
Panjab :
Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Jaipur | Pilani | Udaipur |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh |West Bengal :
Kolkata |Arizona :
Chandler | Tempe | Tucson |California :
Davis | Emeryville | Foster City | La Jolla | Los Angeles | Pasadena | Riverside | San Diego | San Francisco | San Gabriel | Santa Clara | Santa Monica | Stanford |Colorado :
Denver |Connecticut :
Storrs |D.C :
Washington |Florida :
Coral Gables | Gainesville | Tallahassee |Georgia :
Atlanta |Illinois :
Abbott Park | Champaign | Chicago | Deerfield |Indiana :
Bloomington | West Lafayette |Kansas :
Lawrence |Maryland :
Baltimore | Rockville |Massachusetts :
Boston | Cambridge | Medford and Somerville | Rockland |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
Fulton | St. Louis |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Linden | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Warren Grove | Westfield | Whippany |New York :
Buffalo | Ithaca | Morningside Heights |North Caroline :
Chapel Hills | Raleigh |Ohio :
Columbus, |Pennsylvania :
Philadelphia | Pittsburgh |Tennessee :
Nashville |Texas :
Austin | Houston |Virginia :
Blacksburg |Washington :
Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Hesse :
Marburg |Hessen :
Frankfurt |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |New South Wales :
Sydney |Queensland :
Queensland |United Kingdom :
London |Serbia :
Belgrade |Republic of Ireland :
Dublin | Limerick |Remote :
Remote | Remote, USA | Switzerland | Remote - Europe |Makkah :
Jeddah | Najran |
