QA Specialist II

Scorpion Therapeutics; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Scorpion Therapeutics is seeking an experienced QA professional to support oversight of GMP compliant drug substance and OSD pilot plant operations. You will review manufacturing documents, ensure ALCOA records, and assist with investigations and changes to quality systems.

The role involves cross-functional collaboration, basic root-cause analysis, and preparing for regulatory inspections. BS with 4+ years or MS with 2+ years in pharma GMP is preferred, with strong communication and MS Office

Qualifications

• 4+ years in GMP environment with BS; OR 2+ years with MS.
• Prior pharmaceutical industry experience preferred.
• Experience reviewing and approving manufacturing documentation.

Responsibilities

• Supports QA oversight of clinical small molecule drug substance and OSD pilot plant manufacturing and product disposition.
• Reviews and approves batch records, deviations, investigations, CAPAs, change controls, and reports.
• Maintains ALCOA quality records per GMP and quality systems.
• Supports QA team in daily operations and process improvements.
• Participates in cross functional projects delivering QA deliverables.
• Executes basic root cause analyses and risk-based investigations.
• Identifies data trends and compliance risks; escalates appropriately.
• Leads revision of GMP documentation to support QA projects.
• Creates metrics and reports; supports regulatory inspections and internal audits.

Skills

Verbal, written and interpersonal comm

MS Office proficiency

Quality assurance knowledge

FDA/EMEA standards knowledge

Six Sigma/LEAN knowledge

Root cause analysis

Education

BS in related field

MS in related field

Tools

Microsoft Office

Job description

Specific Job Responsibilities:

• Supports QA oversight of clinical small molecule drug substance and oral solid dosage (OSD) pilot plant manufacturing, warehouse, and is responsible for product disposition using risk-based and clinical phase-appropriate approach.
• Reviews and approves manufacturing documentation (batch records, product release documentation, deviations, investigations such as OOS/OOT/atypical, CAPAs, change controls, protocols, and reports).
• Maintains accurate, complete, and timely (ALCOA) quality records in accordance with GMP and quality systems.
• Supports QA team members in daily operations (lot disposition) and team process improvement projects.
• Participates in departmental and cross-functional projects delivering assigned QA deliverables.
• Supports small to moderately complex process improvement projects.
• Executes basic root cause analysis and uses risk-based thinking to support investigations and quality events.
• Identifies data trends/anomalies and potential compliance risks; escalates appropriately.
• Leads revision of GMP documentation to support QA projects.
• Creates metrics and reports under supervision of senior QA team members.
• Supports regulatory inspections and internal audits (preparation, execution, observation response generation).

Knowledge / Required Skills:

• Working knowledge of cGMPs; quality assurance systems/methods/procedures.
• Knowledge of FDA/EMEA standards and quality systems.
• Basic knowledge of Six Sigma, LEAN, and root cause analysis tools.
• Verbal, written, and interpersonal communication skills.
• Proficiency in Microsoft Office.

Basic Qualifications:

• 4+ years relevant GMP-environment experience with a BS; OR 2+ years with an MS.
• Prior pharmaceutical industry experience preferred.