Quality Specialist
Company: Eagle Analytical
Location: Houston
Posted on: June 24, 2025
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Job Description:
Job Details Description The Quality Specialist is responsible
for the review of analytical documentation including methods,
validations, protocols, analytical data, reports (microbiology and
chemistry logs and worksheets), investigations (OOS, NCR, CAR, DV,
and customer complaints), and change control documentation. Possess
the ability to interpret and apply Current Good Manufacturing
Practices (cGMP), ISO 17025 standards, American Association for
Laboratory Accreditation (A2LA) requirements, U.S. Pharmacopeial
Convention (USP), and Good Laboratory Practices (GLP). Essential
Responsibilities • Ensure compliance with Eagle policies and
Standard Operating Procedures (SOPs) and Quality Management System.
• Ensures ISO 17025, cGMPs, cGLPs, USP guidelines are interpreted
and followed throughout the Eagle. • Write, review, and approve
SOPs, test methods, laboratory reports, laboratory logs/worksheets,
work instructions, forms, deviations, CAPA’s, change controls, and
other relevant GMP records for compliance. • Review laboratory test
reports, environmental monitoring, and quality control data. •
Support and conduct internal audits of quality documentation and
system and perform daily walk-through audits to ensure compliance
of all departments. • Review root cause analysis and implementation
of corrective action for process related concerns. • Assist in
creating and maintaining company quality documentation, such as
quality manuals, quality procedures, etc. • Manage auditing and
storage of quality documentation and quarantined items. •
Responsible for the preparation of training materials for all
departments Qualifications • Minimum Bachelor of Science in life
science or related field required. • Two (2) years’ experience in
Quality Assurance, Sterile Compounding and/or GMP production
facility preferred. • Two (2) years’ experience with FDA regulated
operations (cGMP processes) preferred. • Strong Microsoft Office
with ability to input data into other software programs. •
Excellent organizational, interpersonal, and time management
skills. • Excellent attention to detail with strong verbal and
written communication skills. • Ability to provide conflict
resolution, i.e., quality issues operations. • Ability to work in a
collaborative team environment. • Knowledge of 21 CFR Part 210 &
211 a plus. Certifications: • ASQ preferred Qualifications Skills
Behaviors : Motivations : Education Experience Licenses &
Certifications Equal Opportunity Employer This employer is required
to notify all applicants of their rights pursuant to federal
employment laws. For further information, please review the Know
Your Rights notice from the Department of Labor.
Keywords: Eagle Analytical, Houston , Quality Specialist, Science, Research & Development , Houston, Texas
