JOB SUMMARY
The GMP Quality Assurance contractor will work 40 hours per week and 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Review/Approval of manufacturing release testing and stability batch records for compliance
- Review and QA release of DS and DP batches at external manufacturing vendors, including working with EU QP for release.
- Review of supply chain documentation and packaging and labelling activities.
- Review/approval of Change Controls from manufacturing, analytical and supply chain.
- Review/approval of deviations, investigations, OOS/OOT.
- Review/approval of Analytical Chemistry data/documentation from external vendors in US and EU in support of in-process, release, stability, and method validations ensuring quality compliance to regulatory guidance’s and specifications.
- Assist in GMP audits as
- Support the QA review of internal and external documentation for compliance with approved documentation, established standards, and regulations.
- Assist in the assessment of specifications, validations, reference materials and test
- Input into Gossamer internal QMS – complaints, OOS, investigations and any other activities as required.
- Review and update of GMP related SOPs and policies as needed.
JOB QUALIFICATIONS
Education, Certifications, Experience
- 5+ years of relevant experience in the area of GMP Quality Assurance in the pharmaceutical industry, preferably with small molecules
- Bachelor's degree with 5+ years of relevant experience in the area of GMP Quality Assurance, Analytical Chemistry/Quality Control, Manufacturing/Supply chain in the pharmaceutical industry in a clinical setting.
- Understanding of clinical trial phases leading up to commercialization.
- Proficiency in multiple Analytical techniques such as HPLC, GC, FTIR, etc
- Ability to interpret analytical data.
- Experience working with Contract Manufacturing Organizations
- Experience in using electronic document systems.
- Experience in combination products/medical devices would be advantageous.
- Working knowledge of cGMPs – FDA, EMEA.
Professional Requirements:
- Excellent communication skills, both oral and
- Excellent interpersonal skills, collaborative approach
- Self-motivated and comfortable in a fast-paced company environment
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-$70/hr. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below:
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.
