• Login / Signup
    • Instagram
    youtube
    Facebook

    Cgmp Quality Specialist

    Strata-G Llc
    5+ years
    Preffered by Company
    Remote, USA
    10 Sept. 3, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position: cGMP Quality Specialist

    Company Overview:

    At Strata-G, our impact is defined by the exceptional talent we hire, the strong relationships we build with our clients, and the positive contributions we make to our community. Our team of driven engineers, scientists, and business professionals collaborates to tackle complex energy and environmental challenges worldwide. Our core values foster a culture of meaningful change for both our clients and the world:

    • We Care: We treat our customers and employees with respect and empathy.
    • Integrity: We uphold honesty and ethical practices in all our endeavors.
    • Service: We aim to exceed customer expectations through relentless improvement.
    • Quality: We foster a culture of continuous enhancement.
    • Safety: We prioritize the health and safety of our associates, customers, the public, and the environment.
    • Innovation: We create inventive solutions to better serve our clients.
    • Attitude: We maintain a positive outlook and value humor.
    • Outreach: We share our successes with the community.

    Position Summary:

    Strata-G is seeking a seasoned cGMP Quality Specialist to ensure that radioisotopes intended for use as Active Pharmaceutical Ingredients (APIs) are produced under stringent controls and appropriate facility environments.

    Key Responsibilities:

    • Interpret and apply quality assurance requirements from 21 CFR 211 and ICH Q7 to work procedures and documentation.
    • Review and approve production batch records for the release of radioisotope products.
    • Develop and assess technical procedures and documents for QA compliance.
    • Oversee change controls related to processes, equipment, and facilities.
    • Maintain filings with the FDA and other regulatory agencies, including the Drug Master File.
    • Conduct cGMP training and develop strong internal and external relationships to address issues and concerns.
    • Guide the deployment of management systems and assist with non-conformance processing.
    • Evaluate assessment findings and improvement opportunities to ensure proper closure.
    • Collaborate with customers to meet goals and assess satisfaction.
    • Identify and resolve issues to achieve business results.

    Basic Qualifications:

    • Bachelor’s degree in Science, Quality Assurance, or a related field.
    • Minimum of five years of relevant quality experience; a combination of education and experience may be considered.
    • Knowledge of current Good Manufacturing Practices (cGMP) for drug manufacturing.
    • Ability to obtain and maintain a clearance from the Department of Energy, including passing a pre-placement drug test and participating in random drug testing.

    Preferred Qualifications:

    • Strong computer and organizational skills, with the ability to multitask effectively.
    • Excellent oral and written communication skills.
    • Experience with quality-related aspects of analytical methods such as gamma spectroscopy or inductively coupled plasma spectroscopy.
    • Experience in radioisotope production and with new facility design and environmental controls for manufacturing.
    • Familiarity with radioactive decay calculations.
    • Proven experience in quality assurance activities, including supporting regulatory and customer audits, investigating non-conformances, and implementing corrective actions.
    • Experience with document change control systems and evaluating changes against regulatory requirements.
    • Demonstrated ability to collaborate with internal and external organizations.
    • Experience in quality oversight of drug manufacturing, including production record approval and process validation.
    • Strong self-motivation, creativity, and passion with the ability to meet deliverables in a dynamic environment.

    Job Details:

    • Type: Contract (3 to 4 months)
    • Location: Oak Ridge, TN (Hybrid option available; onsite presence required as needed)

    Additional Information:

    Strata-G does not sponsor work visas. Candidates must provide evidence of identity and employment authorization. Drug testing and a potential background investigation by the Federal government may be required. Strata-G is an Equal Employment Opportunity (EEO) employer and provides equal opportunities to all qualified applicants without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veteran status, or disability. All job descriptions are evaluated based on physical/mental standards according to AAP guidelines.

    Latest Jobs

    Medical Coder

    Aims Tech Services
    Remote

    Hospital Pharmacist

    Rx Relief
    Downey

    Principal Statistical Programmer

    Novartis
    India

    Senior Principal Biostatistician

    Novartis
    India

    Associate Director - Pks Drug Disposition, Hyd

    Novartis
    India

    Tco Physician

    Novartis
    India

    Director - Pks Gh Ta Lead

    Novartis
    India

    Medical Director Ii

    Novartis
    India

    Clinical Operations Specialist

    Novartis
    India

    Analyst, Global Stability

    Endo
    Pudupakkam Pune

    Pharma Jobs in India

    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 | Halol | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

    Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Baddi | Solan |

    India :

    Siliguri |

    Jharkhand :

    Ranchi |

    Karnataka :

    B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Bhopal | 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 | Pudupakkam | 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 :

    Digha | Kolkata | Mukundapur |

    Pharma Jobs in United States

    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 | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hoopa | 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 | Kansas City | Lawrence | McPherson |

    Kentucky :

    Edgewood | 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 | Montville | 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 | Rocky Mount | Sanford | Scottsdale |

    North Dakota :

    Dickinson |

    northeastern :

    New Hampshire |

    Ohio :

    Cincinnati | Cleveland | Columbus, | Dayton | Erie | Macedonia | Oregoina | oxford | Waynesville |

    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 |

    Pharma Jobs in Germany

    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 :

    Darmstadt | Marburg |

    Hessen :

    Frankfurt | Harveysburg |

    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 |

    Pharma Jobs in Europe

    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 |

    Pharma Jobs in China

    China :

    China |

    Hubei :

    Wuhan |

    Liaoning :

    Dalian |

    Republic of China :

    Beijing |

    Shanghai Sai :

    Shanghai Shi |

    Tokiyo :

    Osaka | Tokyo |

    Zhejiang :

    Hangzhou |

    Pharma Jobs in Ireland

    Cork :

    Ringaskiddy |

    County Dublin :

    Swords |

    Dún Laoghaire :

    Dún Laoghaire |

    Republic of Ireland :

    Dublin | Limerick | Waterford |

    Ulster :

    Donegal |

    Pharma Jobs in Australia

    New South Wales :

    Ballina | Sydney |

    Queensland :

    Queensland |

    Remote Australia :

    Remote Australia |

    Republic of Western Australia :

    Nedlands |

    Pharma Jobs in Netherland

    Capital of Netherland :

    Amsterdam |

    Netherlands :

    Netherlands |

    Noord Holland :

    Haarlem |

    South Holland :

    Leiden |

    Pharma Jobs in United Kingdom

    Antrim :

    Larne |

    Cheshire :

    Runcorn |

    Hertfordshire :

    Welwyn |

    Surrey :

    Pirbright |

    Pharma Jobs in Argentina & Austria & Belgium & Bosnia and Herzegovina & Bulgaria & Canada & Chile & Colombia & Croatia & Czechia & Egypt & England & Estonia & Federated States of Micronesia & Finland & France & Greece & Indonesia & Israel & Italy & Japan & Kazakhstan & Korea & malaysia & Mexico & Philippines & Poland & Portugal & Remote & Romania & Saudi Arabia & Serbia & Singapore & South Afrcia & South America & Spain & Sweden & Taiwan & Tennessee & Thailand & Turkey & Ukraine & United Arab Emirates & Vietnam

    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 :

    North York | Mississauga | Richmond Hill | Uxbridge |

    Quebec :

    Montreal |

    Chile :

    Santiago |

    Republic of Colombia :

    Bogota |

    Croatia :

    Croatia |

    Zagreb :

    Zagreb |

    Bohemia :

    Prague |

    Republic of Egypt :

    Cairo |

    South Yorkshire :

    Sheffield |

    United Kingdom :

    London | Leeds | Harlow | Salt Lake City | United Kingdom | Maidenhead | Stirling |

    Estonia :

    Tartu | Estonia |

    Harju County (Maakond) :

    Tallinn |

    Chuuk :

    North Ostrobothnia :

    Oulu |

    Southwest Finland (Varsinais-Suomi) :

    Turku |

    France :

    Paris | Lyon |

    Attica :

    Athens | Koropi |

    Greece :

    Greece |

    East Java :

    Surabaya |

    Jakarta :

    Jakarta |

    Israel :

    Netanya | Be'Er Sheva | Kfar Saba | 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, USA | Remote - Europe | Switzerland | Remote - Middle East |

    Bucharest :

    Bucharest |

    Makkah :

    Jeddah | King Abdullah Economic City | Rabigh | Khulais | Riyadh | Najran |

    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 :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |