Senior Quality Assurance Specialist

Location
South San Francisco, CA, United States
Posted
Feb 04, 2021
Ref
2170
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Sutro has a unique capability that enables new molecular entities to be designed using a hybrid of synthetic and recombinant technologies to create best in class therapeutics in the oncology and auto-immune disease space. Our portfolio includes antibody-drug conjugates, bispecific antibodies, cytokine derivatives and other novel immuno-stimulatory approaches.

Sutro Biopharma, Inc. is looking for an energetic and talented professional to join its External Quality Assurance (QA) Group. This group is responsible for overseeing the entire external supply chain from the QA perspective ensuring compliance with regulations and adherence to partner Quality Agreements. This individual will be assisting Quality Organization strategies to establish a robust cGMP facility. The Senior Quality Assurance Specialist is a hands-on QA professional capable of performing tactical tasks. You will be working to develop new processes to maximize our technology and enhance our internal and collaborative product development initiatives in a fast-paced environment.

Responsibilities
  • Support External Quality function in the areas of lot release for Internally and Externally produced products.
  • Perform Quality Records revisions that are related to External Quality's role in releasing products, qualification and audits of external partners and adhering to Quality Agreements.
  • Provide further definition to the current External Quality Dashboard to be a useful tool for Lot Release, Audits, PIP Visits and tracking of Qualification and Quality Systems Documentation for External Quality.
  • Perform Qualification Audit activities as needed for externally contracted organizations (CMO's/CTO's.)
  • Subject Matter Expert (SME) on Documentation Control platforms such as Master Control to drive efficiency and maximum utilization of the system.
  • Conducting Quality reviews of production documentation, including production batch records, analytical records, and any supporting documentation to ensure compliance with cGMPs and Sutro policies and procedures.
  • Develops, applies, revises, and maintains quality system protocols/methods/procedures.
  • May assure compliance to in-house and/or external specifications and standards, (i.e., GLP, GMP, ISO, Six Sigma).
  • May assist/support in Quality Operations activities including processing change controls, deviations and CAPAs.
  • Expected to effectively follow Sutro Biopharma's SOPs and policies, and cGMP compliance regulations. Additionally, the individual should be able to independently manage review times to meet Sutro's priorities and communicated timelines.
  • May be asked to travel on behalf of Sutro Biopharma to support External QA initiatives. Anticipated travel is minimal from 0-10%.


    • Qualifications
    • 3-5 years of Quality Assurance/Quality Systems and/or Compliance related experience in a cGMP regulated manufacturing environment is required.
    • Bachelor's degree or higher in a relevant scientific area is strongly preferred.
    • Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.
    • Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
    • Results self-driven with a "can do" positive attitude.
    • Knowledge and ability to sufficiently train others on regulatory compliance issues
    • Strong interpersonal skills and ability to work with others in a positive and collaborative manner.
    • Strong verbal and written communication skills essential
    • Strong communication, prioritization, and organizational skills
    • Knowledge of cGMP concepts and guidelines, as well as good documentation practices
    • Ability to utilize multiple word-processing and database applications. Experience with contract manufacturing operations is a plus.


    • Please submit resume for Req. #2170 to jobs@sutrobio.com . Please visit our website at www.sutrobio.com for more information.

      Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.

      Sutro Biopharma is committed to the diversity of our team and we are committed to Equal Employment Opportunity without regard for race, ethnicity, gender, protected veteran status, disability, sexual orientation, gender identity or religion.

      Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.

      Please be advised, inquiries or resumes from recruiters will not be accepted.