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QA Engineer

Argenta
Shawnee, USA
Mid · 3+ years experience
Onsite
Discovered 2 weeks ago
Communication

Full Job Posting

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
  • Fluent in Microsoft programs
  • Argenta has strongly embedded company values which is key to who we are and how we deliver. We offer an opportunity to work for a successful and rapidly expanding global business where your input will be valued. At Argenta we are a hard-working group who really enjoy the people we work with each day. That is why we support our people through a strong culture, great benefits, and growth opportunities.
  • Argenta is an equal-opportunity employer
  • To find out more about Argenta, click here: www.argentaglobal.com

Qualifications

  • 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.
  • 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
  • Fluent in Microsoft programs
  • Argenta has strongly embedded company values which is key to who we are and how we deliver. We offer an opportunity to work for a successful and rapidly expanding global business where your input will be valued. At Argenta we are a hard-working group who really enjoy the people we work with each day. That is why we support our people through a strong culture, great benefits, and growth opportunities.
  • Argenta is an equal-opportunity employer
  • To find out more about Argenta, click here: www.argentaglobal.com

Preferred Qualifications

  • Experience in Sterile Manufacturing and/or Laboratory testing a plus.

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