GMP QA Contractor

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.

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 _________. 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: