Clinical Trials
4 weeks ago
My client is seeking a dynamic and hands-on Quality Assurance Analyst to lead and manage our QA activities. As a key member of our small, agile team, you will be responsible for ensuring the highest quality standards are met.
Key Responsibilities:
- Partner with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of Quality and Safety
- Provide Quality Oversight of the manufacturing facility including manufacturing operations, testing, inspection and utilities.
- Strong purposeful presence on the manufacturing floor
- Participates in and provides quality oversight for quality records including Deviations and Change Controls, assuring adherence to procedural requirements and regulatory expectations.
- Reviews and approves controlled documents, including Standard Operating Procedures, Protocols and Reports.
- Ensures that operations align with applicable regulations
- Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
- Contribute to and drive continuous improvement projects in cross-functional collaboration.
Experience::
- Bachelors Degree in Biochemistry, Biology, Chemistry, or related science field
- Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
- Experience managing projects through to completion meeting timelines.
- Ability to evaluate documentation and operations according to company procedures.
- Experience working with Quality Systems
- Strong organizational skills and ability to manage multiple tasks at one time
- Effective communication skills (both written and verbal)
- Demonstrated ability to work as both a team player and independently
- Display leadership attributes and drive improvement initiatives
- Solid understanding and application of aseptic behaviors and principles
Why Join my client?
- Be part of a pioneering biotech company dedicated to developing cutting-edge therapies.
- Work in a collaborative and fast-paced environment with the opportunity to make a significant impact on the company’s success.
- Competitive compensation package, including benefits and opportunities for professional growth.
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