Senior Quality Control Associate- Direct Materials

3+ years

Not Disclosed

Remote, USA

10 Feb. 14, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Senior Quality Control Associate - Direct Materials
Location: Hillsboro, Oregon, United States
Category: Quality
Job Id: 202412-132123

Position Overview:

Roche's Hillsboro Technical Operations (HTO) team is looking for a Senior Quality Control Associate to join their dynamic and fast-paced Quality Control Operations team. This role plays a critical part in ensuring the quality of Direct Materials in the manufacturing of biologics drug products and finished goods for both commercial and launch products.

Key Responsibilities:

Testing & Review:
- Perform routine testing, review, and approval of Direct Materials in full compliance with cGMP regulations.
- Establish and implement SOPs, specifications, and testing methods.
Technical Support & Issue Resolution:
- Provide technical input and support for resolving discrepancies, deviations, and operational/technical issues.
- Lead or perform analytical activities (e.g., assay transfer and assay validation) to meet project timelines.
Training & Audit Support:
- Develop and deliver training to team members.
- Support internal and external audits and regulatory inspections.
Data Review & Investigation:
- Review technical data against established acceptance criteria.
- Identify discrepancies and contribute to the design of quality investigations and CAPA initiatives.
Cross-Functional Team Participation:
- Lead or participate in project teams and process improvement initiatives.
- Serve as a technical subject matter expert (SME) in support of department functions.
Quality & Regulatory Compliance:
- Notify management of any potential quality or regulatory issues affecting product quality or compliance.

Qualifications & Requirements:

Education:
- A B.S./B.A. degree in Biology, Biochemistry, Molecular Biology, or a related scientific discipline.
- At least 5 years of relevant experience or an equivalent combination of education and experience in the pharmaceutical or biopharmaceutical industry.
Experience:
- A minimum of 3 years of experience working in a GMP (Good Manufacturing Practices) environment.
Skills:
- Strong verbal and written communication skills.
- Ability to interpret and apply quality standards to operational activities.

Physical Demands & Work Environment:

Physical Demands:
- Prolonged periods of standing at the lab bench.
- Frequent lifting (up to 25 lbs), bending, reaching, and climbing stairs.
Safety Considerations:
- May involve exposure to reagents and chemical compounds, including acetonitrile, acids, biologic toxins, microorganisms, and potent compounds.

Salary & Benefits

Salary Range:
- Expected salary range is $68,300 - $126,900 annually. Actual pay will depend on experience, qualifications, and geographic location.
- A discretionary annual bonus may be available based on individual and company performance.
Relocation:
- Relocation benefits are available for this position.
Benefits:
- This role is eligible for the comprehensive benefits detailed at the provided link.

About Roche/Genentech:

Genentech, a member of the Roche Group, is a leader in biotechnology, dedicated to developing novel medicines for serious and life-threatening diseases. With over 40 years in the industry, we value our employees and focus on creating an inclusive, diverse environment where everyone can thrive and contribute their best for the patients we serve.

Latest Jobs

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Delhi :

Delhi | India | New Delhi | PAN-India |

Goa :

Goa | Panaji | Verna |

Gujarat :

Haryana :

Himachal Pradesh :

Baddi | Solan |

India :

Siliguri |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Madhya Pradesh :

Maharashtra :

Odisha :

Bhubaneswar | Rourkela |

PAN-India :

Panjab :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Punjab :

Rajasthan :

Sikkim :

Rangpo |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh | Roorkee |

West Bengal :

Digha | Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Albama :

Tuscaloosa |

Arizona :

Arkansas :

Fort Smith |

California :

Colorado :

Boulder | Denver | Westminster |

Connecticut :

D.C :

Washington |

Delaware :

Wilmington |

Florida :

Georgia :

Atlanta | Rome |

Hawaii :

Hilo | Honolulu |

Idaho :

Boise |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Garden city | Kansas City | Lawrence | McPherson |

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Kington :

Frank Scottile Blvd |

LA :

Baton Rouge | Monroe | New Orleans |

Louisiana :

Lake Charles | Shreveport |

Maine :

Bangor | Brewer |

Maryland :

Massachusetts :

Michigan :

Detroit | Houghton Lake |

Minnesota :

Missouri :

Fulton | Milan | St. Louis |

Nebraska :

Hebron | Nebraska City |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Manchester |

New Jersey :

New Mexico :

Farmington | Santa Fe | Tucumcari |

New York :

North Carolina :

Concord | Lumberton | North Carolina |

North Caroline :

North Dakota :

Dickinson |

northeastern :

New Hampshire |

Ohio :

Oklahoma :

Oklahoma City |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Oeiras | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

South Carolina :

Charleston |

Tennessee :

Memphis | Nashville |

Texas :

United states :

fairmont | Georgia | OH | United States |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

WI :

Madison | Wausau |

Wisconsin :

Portage |

Wyoming :

Big Piney | Cokeville |

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

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 :

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Rotherbaum :

Hamburg |

Saarland :

Saarbrucken |

Saxony Anhalt :

Halle |

Schleswig Holstein :

Kiel |

Pharma Jobs in Europe

Belgium :

Wavre |

BULGARIA :

Bulgaria |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in China

China :

China | Quarry Bay |

Hubei :

Wuhan |

Liaoning :

Dalian |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Zhejiang :

Hangzhou |

Pharma Jobs in Australia

Melbourne :

South Yarra |

New South Wales :

Ballina | Sydney |

Queensland :

Queensland |

Remote Australia :

Remote Australia |

Republic of Western Australia :

Nedlands |

Pharma Jobs in Ireland

Cork :

Ringaskiddy |

County Dublin :

Swords |

Dún Laoghaire :

Dún Laoghaire |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

Netherlands :

Netherlands |

Noord Holland :

Haarlem |

North Brabant :

Breda |

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 & New Zealand & Peru & 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 |

Flemish Brabant :

Zaventem |

Bosnia and Herzegovina :

Sarajevo |

Sofia City :

Sofia |

Canada :

Canada |

Ontario :

Quebec :

Montreal |

Chile :

Santiago |

Republic of Colombia :

Bogota |

Croatia :

Croatia |

Zagreb :

Zagreb |

Bohemia :

Prague |

Republic of Egypt :

Cairo |

Oxfordshire :

Witney |

South Yorkshire :

Sheffield |

United Kingdom :

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 :

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 |

North Island :

Auckland |

Lima Region :

Lima |

Cebu Province :

Cebu City |

Philippines :

Manila |

Mazovia :

Warsaw |

Remote :

Bucharest :

Bucharest |

Makkah :

Nišava District :

Niš |

Singapore :

Singapore |

South Africa :

South Africa | Midrand |

Brazil :

Sao paulo | Brazil |

South America :

Argentina | Peru |

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 |

Senior Quality Control Associate- Direct Materials

Job Description

Position Overview:

Key Responsibilities:

Qualifications & Requirements:

Physical Demands & Work Environment:

Salary & Benefits

About Roche/Genentech:

Latest Jobs

Quality-Medical Affairs Professional

Medical Writing – Medical Affairs

Quality Medical Reviewer – Medical Affairs Quality

Specialist - Medical Editor

Specialist - Quality Operations (Gqs I)

Patient Safety Specialist

Global Medical Development Manager