QA Associate
1 week ago
Position Overview: We are seeking a detail-oriented and dedicated QA Associate to join our Quality Assurance team. This position will primarily focus on document management, deviation investigation, CAPA (Corrective and Preventive Action) implementation, and other related responsibilities.
Key Responsibilities:
Document Management:
Coordinate and maintain the document control system, ensuring all documents are up-to-date and comply with quality standards.
Review, approve, and archive controlled documents, including SOPs, batch records, and other quality-related documents.
Deviation Investigation:
Conduct thorough investigations into deviations from established procedures, specifications, and quality standards.
Collaborate with cross-functional teams to determine root causes and propose effective corrective and preventive actions.
CAPA Implementation:
Lead the implementation of CAPAs, ensuring timely and effective resolution of identified issues.
Monitor and track CAPA progress, and provide regular updates to relevant stakeholders.
Quality Compliance:
Assist in the preparation and conduct of internal and external quality audits.
Ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulatory requirements.
Training and Communication:
Provide training on quality processes and procedures to relevant personnel.
Communicate quality-related information to teams, fostering awareness and adherence to quality standards.
Continuous Improvement:
Identify opportunities for process improvements within the quality assurance function.
Participate in the development and implementation of initiatives to enhance overall quality performance.
Other Duties:
Undertake additional responsibilities as assigned by management.
Qualifications:
Bachelor’s degree in a relevant scientific field or equivalent experience.
Minimum of 2 years of experience in quality assurance in the biotechnology or pharmaceutical industry.
Experience in document management, investigations, and CAPA processes.
Familiarity with cGMP and other relevant quality standards and regulatory requirements.
Excellent communication and organizational skills.
LOCATION:
Wheeler Bio’s headquarters are in Oklahoma City, OK. Because it is expected that this individual will work and operate onsite, he or she will be required to relocate to the Oklahoma City headquarters to lead this expanding team.
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