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. 

The expected pay for this position is $20.00 - $25.00 per hour depending on the candidate's skills, experience and other qualifications. Payroll will be through a 3rd party vendor.

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.

Vaccination Policy:  Gossamer Bio is committed to complying with federal, state and local law on vaccinations.  Job candidates and employees should be aware that some roles may require full vaccination against COVID-19 . Gossamer Bio is an equal opportunity employer, and will provide reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

California Consumer Privacy Act (CCPA) Notice for California Residents:
This notice is to notify you that personal data about you has been collected by Gossamer Bio (“Controller”), which is located at 3013 Science Park Road, Suite 200, San Diego CA 92121 and can be contacted by emailing privacy@gossamerbio.com, because Controller wishes to evaluate your candidacy for employment at Controller.

Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment.  Controller’s Privacy team can be contacted at privacy@gossamerbio.com.  

Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes.  Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.

Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf.   

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted.  You also have to right to data portability.  In addition, you may lodge a complaint with a supervisory authority.

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