Quality Assurance Consultant - Oklahoma City, United States - Discover International

Description

Job Title:
Quality ConsultantLocation: Fully Remote (Boston, MA preferred)

Duration: 3 to 6 months (initial contract)

Hours: 5 to 10 hours per week

Job Description:

As a Quality Assurance Consultant, you will play a pivotal role in setting up and refining the clients QA processes to ensure compliance, efficiency, and excellence in our biotech operations.

You will also be responsible for managing out the start ups out-license project, ensuring alignment with regulatory standards and industry best practices.

Key Responsibilities:

QA Process Development:
Collaborate with the team to establish robust QA processes tailored to our gene therapy mRNA/gene editing projects

Quality Control Implementation:
Oversee the implementation of QA/QC measures to monitor and maintain the quality of our products and processes

Regulatory Compliance:
Stay abreast of regulatory requirements and industry standards, ensuring our operations adhere to relevant guidelines

Out-License Project Management:
Lead the management of our out-license project, coordinating activities and ensuring deliverables meet contractual obligations and quality standards

Risk Assessment:
Identify potential risks and develop mitigation strategies to safeguard product quality and project timelines

Documentation and Reporting:
Maintain accurate documentation of QA activities and generate regular reports to track progress and identify areas for improvement

Training and Support:
Provide guidance and support to team members on QA-related matters, fostering a culture of quality excellence across the organization

Requirements:

Bachelor's degree in a relevant scientific field; advanced degree preferred.3 to 5 years of hands-on experience in gene therapy mRNA/gene editing within the biotech industry.

Proven expertise in quality assurance and quality control processes, with a strong understanding of regulatory requirements (e.g., FDA, EMA).Excellent project management skills, with the ability to prioritize tasks, meet deadlines, and adapt to changing priorities in a fast-paced startup environment.

Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
Self-motivated and resourceful, with a proactive approach to problem-solving and continuous improvement.
Prior experience in managing out-license projects is a plus.#J-18808-Ljbffr