More jobs:
Quality Supervisor
Job in
New York, New York County, New York, 10261, USA
Listed on 2026-08-30
Listing for:
Scorpion Therapeutics
Per diem
position Listed on 2026-08-30
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers
Job Description & How to Apply Below
Description Overview
The QA Supervisor leads a team of Quality Assurance Inspectors providing quality oversight for bulk manufacturing, filling, and packaging operations for topical and suppository pharmaceutical products, ensuring compliance with cGMP, FDA regulations, internal quality systems, and approved procedures.
Scope of the Role- Supervise, coach, train, and evaluate QA Inspectors.
- Ensure manufacturing/packaging comply with cGMP, FDA regulations, approved procedures, batch records, and internal quality standards.
- Review production, packaging, and quality documentation for accuracy, completeness, and compliance.
- Provide real-time quality support by addressing concerns, conducting risk assessments, and escalating issues.
- Author, revise, review, and approve SOPs, SWIs, forms, and other controlled documents; develop/improve quality systems.
- Lead/support investigations (deviations, non-conformances, documentation errors, environmental monitoring excursions) and ensure CAPA implementation.
- Monitor compliance trends and identify continuous improvement opportunities.
- Schedule/prioritize team activities; ensure GMP training/qualifications.
- Support FDA inspections, customer audits, and internal audits; assist with remediation.
- Support quality metrics, management reviews, and quality system initiatives.
- Bachelor's degree in a scientific discipline preferred; equivalent regulated experience may substitute.
- 4+ years QA experience in a regulated industry.
- Pharmaceutical/biotech/medical device/cosmetics or other FDA-regulated manufacturing experience required.
- Knowledge of cGMP and quality systems.
- Experience reviewing documentation/investigations/deviations/CAPAs/change controls.
- Experience authoring/revising SOPs and controlled documents.
- Supervisory/leadership experience preferred; FDA inspection/audit support preferred.
- Strong written, verbal, organizational, interpersonal skills.
- SAP and/or eQMS knowledge preferred.
First shift, Monday–Friday; occasional weekend on-call support may be required.
BenefitsCompetitive compensation; benefits for you and your family; career development opportunities.
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