Specialist/Senior Specialist Quality Assurance

4 days ago

Redwood City, California, United States Soleno Therapeutics, Inc. Full time $80,000 - $120,000

Summary of Job (brief description)

Soleno Therapeutics, Inc., based in Redwood City, California, is a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases. We are seeking a highly motivated individual to join Soleno Therapeutics who will play a key role within Quality Assurance foroperational support. Responsibilities will primarily include the support of Soleno's CMOs/CTLs covering manufacturing operations and QC activities. The position will also assist in other quality and compliance activities, including, but not limited to, product complaints, deviations, CAPAs, change control, and inspection readiness.

Responsibilities

  •  Support QA oversight of the manufacture and disposition of clinical and commercial product, DS, DP, and FP at CMOs in partnership with CMC, Supply Chain, and QC.
  • Perform the review, approval, and disposition of DS and packaged/labeled drug product, including review of executed batch records, specifications, certificate of analysis, for manufacturing and testing performed by CMOs/CTLs.
  • Collaborate with internal and external stakeholders on quality systems activities such as deviations CAPAs, change controls, and document revisions.
  • Collaborate with QC and Analytical Development to provide quality oversight for GMP activities including approval of release testing and stability for drug substance and drug product.
  • Support clinical and commercial QA activities including product complaints, APQRs, and quality metric reviews.
  • Participates in developing and improving Standard Operating Procedures to ensure quality objectives are met.
  • Participate in inspection readiness efforts.
  • May work on assignments and other duties to support Quality Operations where judgement is required in resolving problems and making recommendations.

Qualifications

  •  Bachelor's Degree in a scientific discipline.
  • Minimum of 2 years of relevant experience in Quality Assurance or a minimum of 5 years relevant experience in the pharmaceutical/biotech industry or equivalent combination.
  • Experience performing supportive quality aspects of manufacturing and testing activities as CMOs.
  • Strong analytical skills and a strong technical background in small molecule process, oral solid dosage, manufacturing is desired.
  • Demonstrates proficiency in Microsoft Office suite (e.g., Word, Excel).
  • Knowledgeable of current regulatory guidance, including GxPs.
  • Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
  • Demonstrates excellent verbal, written, and interpersonal communication skills.
  • Responsible and self-motivated with effective time management, organizational, and planning skills.

Salary Range: $80,000 - $120,000

(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate's relevant qualifications, skills, and experience, as well as the location where this position may be filled.)

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