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Job type
Full-time
Work mode
On-site
Level
Not listed
Department
Quality Assurance
Experience
3+ years experience
Posted
Sep 21, 2026
About the role
Key Responsibilities:
NCR investigations: Identify team members associated with NCRs, schedule meetings and lead the team through deliberate process to achieve completion of complex investigations including determination of the NCR root cause within the time requirements defined in procedures.
Supports the writing of clear and defensible investigations and defined root causes.
CAPAs: Collaborated with the team to determine appropriate CAPAs to address the cause of the NCR to ensure no reoccurrence. Lead the team in identification of setting realistic due dates for completion of CAPA actions.
Document/record approvals
Support Media Fill QA Oversight
New Project support
Interface with Customer Quality Organizations. Act as the Liaison between Argenta and the client for all Quality related issues.
Resolve discrepancies between clients and Argenta
Review and provide input to client Quality Agreements
Support Internal and External Audits
Support Regulatory and Customer Inspections
Drive quality improvements with customers, internal and external, to implement effective quality planning tools, measurement systems and other process controls
Support Compliance Training
Coach colleagues to facilitate a focused knowledge transfer regarding the conduct of quality NCR investigations
About You:
BS/BA Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent related work experience required.
Minimum three+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices. Experience in manufacturing, validations, quality systems and cGMP auditing.
Relevant operations experience in the pharmaceutical industry.
Experience in Sterile Manufacturing and/or Laboratory testing a plus.
Working Knowledge of Document Control Systems and databases
Exceptional knowledge of drug regulations (cGMPs) requirements as well as strong interpersonal, written, and verbal communication skills and be able to interface positively with Regulatory Agencies, Vendors and Company departments.
Manages objectives and balances commitments to prioritize and complete activities within established timelines.
Ability to drive results and influence others outside their direct authority
Demonstrates confident, effective and adaptable communication skills to internal and external customers
Experience with Quality tools, e.g. Cause and Effect Diagrams, Pareto Charts
