26 applicants

Company

Original Job Post

Glaukos Corporation · 2 days ago

Senior Quality Control Scientist

Burlington, MA

Full-time

Hybrid

Senior Level

$130K/yr - $140K/yr

5+ years exp

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Responsibilities

Support implementation/management of Laboratory Systems, including investigations, change controls, CAPA, inspection readiness, and laboratory metrics.

Work closely with external operation teams to provide technical expertise for quality technical aspects of drug product and analytical testing.

Oversee cGMP contract testing, review analytical methods, method validations, and ensure Quality Control related documentation meets regulatory guidelines.

Represent Quality on project teams and collaborate with other departments to identify and implement specialized approaches for studying drug potency, impurity levels, and drug distribution.

Manage cGMP stability programs, perform trend analysis on stability data, and act as Subject Matter Expert for analytical test data evaluation.

Ensure documentation of laboratory investigations, change controls, and investigations in the Quality Management System.

Analyze and interpret complex data sets to impact drug development, API stability data, and regulatory requirements.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Pharmaceutical QualityGMP QA/QCLaboratory ExperiencePharmaceutical Industry StandardsRegulatory ComplianceAnalytical ChemistryHPLCFTIRUV/VisDissolution/Drug ReleaseMethod ValidationICH Q2Method TransferStability ProgramsTechnical GuidanceProblem-SolvingCommunication

Required

Bachelor’s degree or equivalent in Chemistry or related field, and 5 years of experience in job offered or as Analytical Scientist/Chemist, or related pharmaceutical QC/QA job. Alternatively, will accept a Master’s degree or equivalent in Chemistry or related field, and 2 years of experience in job offered or as Analytical Scientist/Chemist, or related pharmaceutical QC/QA job.

Experience with pharmaceutical quality, GMP QA/QC compliance or laboratory experience.

Experience with Pharmaceutical Industry standards and regulations (i.e. 21CFR 210/211, 820, ISO 13485).

Experience with clinical, commercial, and multiproduct facilities.

Experience in analytical chemistry (QC and/or R&D).

Experience with HPLC, FTIR, UV/vis, and Dissolution/Drug Release.

Experience in analytical method validation ICH Q2, method transfer, and managing stability programs.

Experience in acting as Analytical Chemistry SME and providing technical guidance to junior scientists and QC chemists.

Good written and oral communication skills.

Requires up to 15% domestic travel.

Company

Glaukos Corporation

At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases—therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.

Founded in 1998

San Clemente, California, USA

501-1,000 employees

http://www.glaukos.com

H1B Sponsorship

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