Quality Assurance Specialist
19 hours ago
{"h1": "Quality Assurance Specialist", "p": "Technical Source is seeking a Quality Assurance Specialist to join our team in the Raleigh-Durham, NC area. This role involves investigating and resolving quality issues, ensuring products, services, and processes meet industry standards and customer expectations. The successful candidate will have experience in quality assurance, regulatory compliance, and process improvement.
Responsibilities:
* Investigate and resolve quality problems, including non-conformities and unscheduled events.
* Ensure accuracy and timely approval of batch production records (BPR).
* Collaborate with process teams to implement preventive actions for recurring quality issues.
* Ensure compliance with training programs and assist in process confirmations to improve quality and compliance.
Qualifications:
* 1-5+ years of Quality Assurance experience in a pharmaceutical environment.
* Knowledge of US and EU regulations, GMPs, and quality standards.
* Ability to coach, develop, and motivate team members while promoting a collaborative and inclusive work environment.
* Familiarity with Lean/Six Sigma methodologies and process improvement techniques is a strong plus.
* Strong written communication, investigative writing, and computer skills (MS Office, SAP, LIMS).
Key Skills:
* Quality Assurance (QA)
* Continuous Improvement
* Compliance
* Process Improvement
* Root Cause Analysis (RCA)
* Regulatory Standards
* Auditing
* Quality Management Systems (QMS)
* GMP (Good Manufacturing Practices)
* Documentation
* Reporting
* Lean/Six Sigma
"}
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