Quality Assurance Specialist

Job Description: QA Specialist

Position Overview: Reporting to the QA Manager, the QA
Specialist role has a primarily focus on document management, deviation investigation, CAPA (Corrective and Preventive Action) implementation, QA On-the-Floor support, Batch record review, and other related responsibilities.

Key Responsibilities:

1. 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.

2. 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.

3. 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.

4. 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.

5. Training and Communication:

· Provide training on quality processes and procedures to relevant personnel, including QA on-the-floor support.

· Communicate quality-related information to teams, fostering awareness and adherence to quality standards.

6. 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.

7. Other duties as assigned.

Qualifications:

Bachelor's degree in a relevant scientific field or equivalent experience.

Minimum of 5 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.

Auditing Experience (Internal and/or External), preferably Regulatory (i.e., FDA).

Excellent communication and organizational skills.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday
• Weekends as needed

Ability to Relocate:

• Oklahoma City, OK 73102: Relocate before starting work (Required)

Work Location: In person

Salary : $60,000 - $100,000