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Company

Gossamer Bio · 8 hours ago

GMP QA Contractor

United States

Contract

Remote

Mid, Senior Level

$60/hr - $70/hr

5+ years exp

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BiotechnologyHealth Care

Growth Opportunities

H1B Sponsor Likely

Hiring Manager

Robyn R.

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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.

Qualification

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GMP Quality AssuranceAnalytical ChemistryHPLCGCFTIRContract Manufacturing OrganizationsElectronic document systemsCGMPs

Required

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

Working knowledge of cGMPs – FDA, EMEA

Excellent communication skills, both oral and written

Excellent interpersonal skills, collaborative approach

Self-motivated and comfortable in a fast-paced company environment

Preferred

Experience in combination products/medical devices would be advantageous

Company

Gossamer Bio

Gossamer Bio is a biopharmaceutical company focused on the discovery and development of novel and differentiated therapeutic products.

Founded in 2015

San Diego, California, USA

51-200 employees

https://www.gossamerbio.com

H1B Sponsorship

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Trends of Total Sponsorships

2021 (4)