- Conduct thorough investigations into deviations, out-of-specification results, complaints, and other quality events to determine root cause and implement corrective and preventive actions (CAPAs).
- Document all investigation activities, findings, and outcomes in accordance with established procedures and regulatory requirements.
- Collaborate with cross-functional teams, including Manufacturing, Quality Control, Regulatory Affairs, and Engineering, to gather relevant information and implement effective corrective and preventive actions.
- Perform risk assessments to evaluate the impact of quality events on product quality, safety, and efficacy.
- Participate in internal and external audits and inspections, providing support and documentation as needed.
- Review and approve change control requests related to manufacturing processes, equipment, and facilities.
- Provide training and guidance to manufacturing personnel on quality systems, procedures, and best practices.
- Stay informed about current Good Manufacturing Practices (cGMP), regulatory requirements, and industry trends to ensure compliance and continuous improvement.
- Bachelor's degree in Pharmacy, Chemistry, Biology, Engineering, or related field required; advanced degree preferred.
- Minimum of 8 to 10 years of experience in pharmaceutical manufacturing, quality assurance, or related field conducting/authorizing investigations.
- Strong knowledge of cGMP regulations, FDA guidelines, and industry standards.
- Experience with investigation methodologies, root cause analysis, and CAPA management.
- Excellent analytical, problem-solving, and decision-making skills.
- Effective communication and interpersonal skills, with the ability to collaborate cross-functionally and influence outcomes.
- Detail-oriented with a commitment to accuracy and compliance.
- Ability to work independently and prioritize tasks in a fast-paced environment.
- Proficiency in Microsoft Office Suite and other relevant software applications.
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Quality Assurance Specialist - North Carolina, United States - Discover International
Description
Job Title: QA Investigator
Location: Raleigh, NC
Duration: 6+ Months Contract
Client: Pharmaceutical
Position Overview:
The QA Investigator will play a critical role in ensuring compliance with regulatory requirements and company standards by conducting thorough investigations into deviations, discrepancies, and non-conformances within the clients manufacturing processes.
Key Responsibilities:
Qualifications:
