Quality Assurance Associate
About The Position
The Quality Assurance Associate provides support to Third-Party Logistics and Warehousing, across the US. The QA Representative provides oversight of operations and directly manages quality functions, guidance to incoming material technicians and will advise on issues such as non-conformance investigations, change control proposals, procedures, commissioning, and qualification activities. This position will also support activities within Warehouse operations, including goods receipt, sampling, and outbound shipping process as well as perform incoming inspections of materials and sampling of items (components, printed packaging materials, etc.) utilizing SAP and LIMS. The QA Associate position is essential for maintaining quality systems, ensuring GMP compliance and in the preparation for inspections by various regulatory agencies.
Requirements
- Demonstrated strong written and verbal communications skills.
- Strong attention to detail.
- Proficiency with computer system applications.
- Knowledge of cGMPs and quality systems.
- Understanding of statistical tools and analysis.
- Excellent interpersonal skills and networking skills.
- Ability to organize and prioritize multiple tasks.
- Previous experience in QA, QC, Manufacturing, Engineering, Tech Services or Regulatory Affairs.
- Experience in inventory management systems (EWM, SAP, etc.)
- BS in Engineering or science-related field or equivalent experience.
- Minimum of 2 years(s) experience within warehouse, logistics, GMP environment
Responsibilities
- Provide direct quality oversight of third-party operations and executed activities.
- Oversee third-party operations across the US, traveling as necessary for on-site support, inspections, and oversight (<50% travel).
- Author, review and approve documents including, but not limited to, procedures, change control proposals, deviations, CARTS, and equipment qualifications.
- Ensures all areas of oversight remain in quality compliance per SOPs and cGMP requirements.
- Provide quality guidance and recommendations regarding materials, utilities, and maintenance.
- Practices safety behaviors with proper PPE and lifting techniques. Supports all HSE Corporate and Site Goals.
- Participate in aberrant data investigations.
- Provide coaching, feedback and mentoring to QA Technicians as it relates to execution of quality systems.
- Work with Operations support groups and external partners to resolve or provide advice on receiving or shipping issues.
- Evaluating damaged materials found on inbound shipments or within the warehouse and determine acceptability.
- Evaluating temperature excursions on shipments received at the warehouse.
- Identifies and assists in resolving issues on shipments (i.e. Incorrect quantity or product, contamination, etc.).
- Performs appropriate transactions in SAP to ensure system represents appropriate status of material (QI, blocked, Investigate customer complaints.)
- Work closely with site customers to report and resolve issues and improve the process.
- Participate in and/or support recalls, as appropriate.
- Conduct gap assessments of global requirements and ensure implementation of the governing standards.
- Participate in and/or lead self-inspection activities.
- Participate in and/or support regulatory inspections and audits.
- Maintain and improve quality systems.
- Assist others in the interpretation of regulatory and corporate requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
