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 | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji | Verna |Gujarat :
Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
Bhubaneswar | Rourkela |PAN-India :
Panjab :
Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Sikkim :
Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh |West Bengal :
Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
Tuscaloosa |Arizona :
Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |Arkansas :
Fort Smith |California :
Alameda | Albion | Arcata | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Morgan Hill | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redding | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | Temecula | Thousand Oaks | Vallejo | West Valley City | Whittier | Willits |Colorado :
Denver |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Newtown | South Windsor | Storrs | West Hartford |D.C :
Washington |Delaware :
Wilmington |Florida :
Boca Raton | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Jacksonville | Maitland | Miami | Naples | Orlando | Pembroke Pines | Port St. Lucie | Rueil-Malmaison | Stuart | Tallahassee | Tampa | West Palm Beach |Georgia :
Atlanta | Rome |Hawaii :
Hilo | Honolulu |Idaho :
Boise |Illinois :
Abbott Park | Champaign | Chicago | Deerfield | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Indiana :
Bloomington | West Lafayette |Kansas :
Garden city | Lawrence |Kenlucky :
Louisville | Shelbyville |Kington :
Frank Scottile Blvd |LA :
Baton Rouge | Monroe | New Orleans |Louisiana :
Lake Charles | Shreveport |Maine :
Bangor | Brewer |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake |Minnesota :
Duluth | Eden Prairie | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
Las Vegas | Tonopah | Tonopsh |New Hampshire :
Lebanon | Manchester |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New Mexico :
Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Buffalo | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Rensselaer | Syracuse | Utica |North Carolina :
Concord | Lumberton | North Carolina |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Sanford | Scottsdale |North Dakota :
Dickinson |northeastern :
New Hampshire |Ohio :
Cincinnati | Cleveland | Columbus, | Erie | Macedonia | oxford |Oklahoma :
Oklahoma City |Oregon :
Bend | Coquille | Corvallis | Eugene | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Pennsylvania :
Ambler | Collegeville | Harrisburg | Lancaster | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Radnor | Spring House | West Chester | Wyomissing |Portugal :
Lisbon | Portugal |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |South Carolina :
Charleston |Tennessee :
Memphis | Nashville |Texas :
Abilene | Arlington | Austin | Brenham | Bulverde | Corpus Christi | Corsicana | Dallas | Fort Worth | Houston | Lakeway | Longview | Plano | Richardson | San Antonio | Tyler | Waco |United states :
fairmont | Georgia | United States |United States :
Hawai | Sylmar |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Bellevue | Bothell | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Vancouver |WI :
Madison | Wausau |Wisconsin :
Portage |Wyoming :
Big Piney | Cokeville |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |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 :
Ingelheim am Rhein | Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |BULGARIA :
Bulgaria |Denmark :
Copenhagen | Denmark |Europe :
Latvia | Leuven | Poland | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Serbia :
Belgrade | Serbia |Switzerland :
Basel | Zurich |China :
China |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Cork :
Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Republic of Ireland :
Dublin | Limerick | Waterford |Ulster :
Donegal |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |South Holland :
Leiden |Buenos Aires :
Buenos Aires |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Mississauga | Richmond Hill | North York | Uxbridge |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |South Yorkshire :
Sheffield |United Kingdom :
Salt Lake City | Maidenhead | United Kingdom | Leeds | Stirling | London | Harlow |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Athens | Koropi |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv |Italy :
Italy |Lombardy :
Rho |Japan :
Japan |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Remote | Remote - Europe | Remote, USA | Remote - Middle East | Switzerland |Bucharest :
Bucharest |Makkah :
Jeddah | Najran | Khulais | Rabigh | Riyadh |Nišava District :
Niš |Singapore :
Singapore |South Africa :
Midrand |Brazil :
Sao paulo |South America :
Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |