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    Senior Quality Control Associate- Direct Materials

    Roche
    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.

     

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

    Nišava District :

    Niš |

    Singapore :

    Singapore |

    South Africa :

    South Africa | Midrand |

    Brazil :

    Sao paulo | Brazil |

    South America :

    Peru | 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 |