Quality Assurance Specialist
2001 Arlingate Columbus, OH 43228 US
Target PR Range:
*Depending on experience
- Collaborates with OPUs, 3PQM and CMOs as needed to review and/or recommend sustainable Corrective Action/Preventive Actions (CAPAs) to be implemented at impacted sites.
- Supports international Quality initiatives/projects.
- Responsible for complaint trending evaluation, leads functional team meetings to ensure that Critical Events are known to local Quality management.
- Helps collaborate and run meetings to provide data for trending of quality systems
- Provides Quality system data to and participates in monthly cross functional Quality Management Review (QMR) meeting and monthly 3PQM QMR
- Actively participates in alignment calls with Ridgefield, HPSG, to drive continuous process improvements.
- Acts as local contact partner/liaison for Brand Safety & Security initiatives.
- Makes determination when to escalate to Quality Commercial Quality and local Quality management.
- Quality Documentation management
- Quality Change management
- Help to ensure Quality procedural updates for GBS and other projects are completed and accurate
- Help to ensure process improvements are implemented
- Ability to respond and act appropriately with all levels under time pressure and regulatory scrutiny. For example, ability to evaluate quality issues and make strategic decisions to minimize the quality and business impact of product batches and campaigns. Escalates and collaborates with quality management to resolve trends impacting product quality.
- Demonstrated knowledge of FDA, cGMP, EU regulations, and USP. Emphasis on management of current good manufacturing practices programs.
- Demonstrated effectively applying cGMP and quality system regulations within the pharmaceutical industry.
- Demonstrated knowledge of Quality Assurance, Production, Laboratories or Regulatory functions within a pharmaceutical environment.
- Excellent communication skills with the ability to influence/persuade individuals.
- Ability to utilize active listening skills to understand the concerns or reasoning to be responsive, gain trust, and build strategic relationships.
- Project management expertise to arrive at quality effective and efficient processes that contribute to product quality.
- Experience using Microsoft applications (Word, Excel) and ERP is preferred.
- Demonstrated investigative techniques to uncover problem areas and recommend corrective actions.
- Problem solving ability requiring attention to detail, accuracy, cGMP, and scientific judgment.
- BA in Chemistry, Pharmacy, or related science Diploma with additional years of experience.
- Minimum five (5) years’ experience with BS/BA pharmaceutical in an area that provides a knowledgeable background for compliance, quality orientation, QA, or manufacturing document review experience.
- Diploma and seven (7) years’ experience in pharmaceutical in an area that provides a knowledgeable background for compliance, quality orientation, QA, or manufacturing document review experience.
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