Senior Quality Control Specialist

1 day ago


Hillsboro, United States Genentech Full time
Job Title:

Sr. QC Pharmaceutical Specialist I

Job Summary:

We are seeking a highly skilled and experienced Sr. QC Pharmaceutical Specialist I to join our team at Genentech. As a key member of our Quality Control team, you will be responsible for leading and supporting the transfer of analytical, microbial, and bioassay methods to and from our site. You will also be responsible for validating these methods, ensuring they meet industry standards and regulatory requirements.

Key Responsibilities:
  • Lead or complete transfer of analytical, microbial, and bioassay methods to and from the site
  • Validate analytical, microbial, and bioassay methods used to test and support the stability of pharmaceutical drug products
  • Define, establish, standardize, implement, and improve practices for maintaining the validated state of analytical, microbial, and bioassay methods throughout its lifecycle
  • Serve as a site representative on network-wide technical method teams
  • Participate in Quality Control Investigations and generate data-based impact assessments
  • Collaborate with key partners to identify and complete Corrective and Preventive Action Plans
  • Author, review, and/or approve various business process and compliance-related documents
Requirements:
  • Bachelor's of Science degree with 8-11 years of dynamic experience in the pharmaceutical or scientific industry or 6-8 years of experience with a Graduate degree
  • 3 years of experience working in a cGMP or similarly regulated environment
  • Deep understanding of analytical, microbial, or bioassay methods, method validation practices, regulations, and industry guidelines
  • Strong problem-solving skills and ability to troubleshoot and resolve method-related issues
  • Judgment and discretion to raise matters of significance and ensure efficient testing operations and regulatory compliance
  • Exceptional social skills and strong written and verbal communication skills
  • Passion and ability for mentoring and encouraging others
Work Environment:

You will be working on site in a flexible open space work environment with random visits to a QC laboratory environment that requires laboratory gowning. You will work on/interact with computerized systems/screens for long periods of time (6-8 hours). You may be required to lift up to 25lbs. You may have to work with hazardous materials and chemicals.

Relocation Benefits:

Relocation benefits are available for this position.

Salary Range:

The expected salary range for the Sr. QC Pharmaceutical Specialist I based on the primary location of Hillsboro, Oregon is $90,200 to $167,600. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.



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