Quality Control Specialist - MES
Job in
Marietta, Lancaster County, Pennsylvania, 17547, USA
Listed on 2026-08-30
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-08-30
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Position Summary:
Provide independent operational quality assurance oversight of GxP processes to ensure adherence to cGxP/GMP and improve effectiveness of quality in preventing/identifying/addressing quality issues. Support Operational MES-related design, implementation, and performance management; ensure MES activities for drug product manufacturing are compliant and data is trustworthy.
Responsibilities:- Provide QA oversight for MES workflows, electronic batch records, and system-controlled manufacturing steps.
- Ensure GMP compliance (validation, quality, safety, environmental) and maintain inspection readiness.
- Review and approve QS change impact and updates to master data (equipment spec file, sM , workstations/work centers) and PI/Main-PI/Sub-PI design/validation (incl. SAP and Osi Pi integration).
- Approve validation forms, DI/business continuity risk assessments, audit trail reviews.
- Develop/approve MES SOPs and child documents.
- Review/deviations/CAPA, logbooks, PQRs, customer complaint investigations, change controls, and validation documents affecting MES/digital records.
- Coach for “Quality Starts With Me,” conduct walkthroughs, lead/support investigations (deviations, system incidents, data anomalies) with root cause analysis and CAPA.
- Support inspections/internal audits and regulatory questions; monitor MES quality KPIs and recommend improvements.
- Bachelor’s degree (Life Sciences/Biology/Chemical Engineering; other disciplines acceptable with sufficient technical depth).
- 3+ years in regulated industry (preferably QA).
- Prior MES implementation experience.
- GMP, NIH Guidelines, FDA/other regulatory compliance; validation principles; aseptic processing; quality systems.
- DMAIC root cause analysis experience; 1+ year hands‑on GMP and good documentation practices.
- Biologics manufacturing experience.
- Familiarity with 21 CFR Part 11 / Annex 11; system validation (IQ/OQ/PQ) or computerized system lifecycle.
- Experience with LIMS/electronic batch records/digital manufacturing solutions.
- Strong communication, coaching, cross‑functional influence, prioritization, and CAPA/root‑cause expertise.
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