What are the responsibilities and job description for the Quality Assurance Specialist (Part-Time Contract) position at Gossamer Bio?
JOB SUMMARY
The GMP Quality Assurance contractor will assist with quality oversight activities for GMP activities including batch record review for release and stability testing of drug substance and drug product. They will assist in the review of compliance documents with established standards and regulations. Collaborate with cross functional CMC team members and support Gossamer cGMP activities. The contactor will work 20-25 hours per week.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Review / approval of manufacturing release testing and stability batch records
- Review of DS and DP batches at external manufacturing vendors.
- Review of supply chain documentation and packaging & labelling activities.
- Review / approval of Change Controls, deviations, investigations, OOS / OOT.
- Review / approval of Analytical Chemistry data / documentation from external vendors in US and EU in support of in-process, release, and stability ensuring quality compliance to regulatory guidance's and specifications.
- Support QA review of internal and external documentation for compliance with approved documentation, established standards, and regulations.
- QMS data entry; complaints, OOS, investigations and any other activities as required.
- Other related tasks and projects as assigned.
JOB QUALIFICATIONS
Education, Certifications, Experience
Knowledge , Skills, and Abilities
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.
The expected pay range for this position is $60-$65 / hr. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law.
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 3115 Merryfield Row, Suite 120, 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.
Salary : $60 - $65
