What You Will Do
Let’s make an impact together. In this crucial role, you will be responsible for overseeing the quality assurance of our document management processes, ensuring compliance with regulatory requirements and industry standards.
As a Senior Associate, you will review documents in the Draft to Effective with Document Change Assessment (DCA) lifecycle to ensure they meet correctness and completeness per the coordinator SOP. You will either approve or reject documents following SOP instructions, with each rejection documented in the tracking and QC form.
You will also perform formatting of documents as per the coordinator SOP and handle document requests, including updates to metadata, changes to document status, and updates to the targeted effective date.
You will initiate the document obsoletion process as needed per the coordinator SOP.
You will generate periodic review reports from the system and notify document owners/managers of overdue reviews. You will manage, monitor, and report on the periodic review process.
You will initiate the regulatory assessment step for document revisions, determining whether a regulatory assessment is needed. If required, you will route documents to a regulatory assessor.
You will follow retention policies outlined in the Company Record Retention Schedule.
You will provide performance monitoring reports on customer service, productivity, and critical process controls to ensure quality and compliance. Additionally, you will assist users in tracking and managing document revision statuses.
You will compile performance data to support the preparation of deviation trend reports on a quarterly basis.
You will perform approvals and rejections of review/approval workflows via the company’s document management system in accordance with SOPs and guidelines.
You will perform quality checks according to company procedures (SOPs) and track document discrepancies. Additionally, you will communicate document, system, and hardware issues to the support team, escalating unresolved issues to management and the DMS Support Team.
You will be expected to perform other related duties as assigned.
What We Expect of You
We are looking for a detail-oriented professional with the following qualifications:
What You Can Expect of Us
At Amgen, we are committed to both your professional and personal growth. We offer a comprehensive benefits package, including competitive pay and a Total Rewards Plan that aligns with industry standards. Our collaborative culture will support you every step of the way.
Apply Now
For a career that challenges and inspires, join us.
Keyword: Senior Associate, Document Management
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Punjab :
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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 | Wrangell |Arizona :
Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |Arkansas :
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Washington |Florida :
Clearwater | Coral Gables | Daytona Beach | Gainesville | Jacksonville | Naples | Orlando | Pembroke Pines | Port St. Lucie | Rueil-Malmaison | Stuart | Tallahassee | Tampa | West Palm Beach |Georgia :
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Boise |Illinois :
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Garden city | Lawrence |Kenlucky :
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Frank Scottile Blvd |LA :
Baton Rouge | Monroe | New Orleans |Louisiana :
Lake Charles | Shreveport |Maine :
Bangor | Brewer |Maryland :
Baltimore | Elkridge | Gaithersburg | Rockville |Massachusetts :
Andover | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake |Minnesota :
Duluth | Hibbing | Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
Fulton | St. Louis |Nevada :
Las Vegas |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 :
Santa Fe |New York :
Albany | Biddle | Buffalo | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Rensselaer | Syracuse | Utica |North Carolina :
Concord | Lumberton | North Carolina |North Caroline :
Carolina Beach | Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Sanford | Scottsdale |North Dakota :
Dickinson |Ohio :
Cincinnati | Cleveland | Columbus, | Macedonia | oxford |Oklahoma :
Oklahoma City |Oregon :
Bend | Coquille | Corvallis | Eugene | Portland | Roseburg | Salem | Springfield |Pennsylvania :
Ambler | Collegeville | Lancaster | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |Portugal :
Lisbon | Portugal |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |South Carolina :
Charleston |Tennessee :
Nashville |Texas :
Abilene | Austin | Bulverde | Corsicana | Dallas | Houston | Longview | Plano | Richardson | San Antonio | Tyler | Waco |United states :
Georgia | United States |United States :
Hawai | Sylmar |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Bothell | Goldendale | Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
Portage |Wyoming :
Cokeville |Baden-Wurttemberg :
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 :
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 |Hubei :
Wuhan |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Buenos Aires :
Buenos Aires |New South Wales :
Sydney |Queensland :
Queensland |Republic of Western Australia :
Nedlands |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Canada :
Canada |Ontario :
Richmond Hill | North York | Uxbridge |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |United Kingdom :
London | Harlow | Salt Lake City | Maidenhead | Leeds | Stirling |Estonia :
Estonia |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Cork :
Ringaskiddy |County Dublin :
Swords |Republic of Ireland :
Limerick | Dublin | Waterford |Israel :
Tel Aviv | Be'Er Sheva | Kfar Saba | Netanya |Italy :
Italy |Tokyo :
Otemachi |Kazakhstan :
Almaty |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Remote - Europe | Switzerland | Remote, USA | Remote |Makkah :
Riyadh | Jeddah | Najran | Rabigh | Khulais |Singapore :
Singapore |South Africa :
Midrand |Brazil :
Sao paulo |South America :
Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Dubai :
Dubai |