Quality Assurance Intern

Summary:

Quality Assurance (QA) is a critical component of the drug manufacturing process. It is the job of QA to ensure that the product that gets to each patient is as safe and efficacious as possible. This is achieved by partnering with departments responsible for the manufacturing and testing of our drug substance and drug product to ensure that appropriate controls are in place to guarantee the product is manufactured consistently and meets all required specifications. In short, QA makes sure products conform to applicable quality, drug stability and safety standards.

Scope:

• Perform the necessary daily responsibilities in accordance with current Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP) regulations.
• Support the review of the organic synthetic route of the manufacturing process/route of the Drug Substance (DS).
• Support the review of GMP documentation (Manufacturing batch records, deviations, out of specifications, certificate of analysis (analytical chemistry-raw data), analytical chemistry (protocols, specifications, and test methods), change controls for DS and Drug Product (DP).
• Manage and maintain trackers for deviations, change controls and DS/DP Genealogy
• Final Project Presentation-With a GMP Focus

Education/Experience/Qualifications:

• Must be currently enrolled in a 4-year bachelor program, preferably a science background majoring in Chemistry or Biochemistry in their Junior or Senior year.
• Grade point average of 3.5 or above
• Must be a self-starter, have strong communication skills, interpersonal skills, as well as strong attention to detail.
• Must have basic troubleshooting and analytical skills.
• Must have good verbal and written communication skills.
• Must be proficient with computers/software (Word, Excel, PowerPoint).
• This is a part-time (up to 20 hours/week) assignment for a duration of 3-6 months. This is a hybrid role to where you will be required to be onsite 1 day/week in our San Diego office.

Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.