QC Scientist- Cell Culture Release Assays - Manhattan, United States - The Steely Group

Description

You Have:

Cell culture experience to perform cell culture release assays. Any experience with HPLC, electrophoresis, ELISA, or endotoxin screening would be great as well.

Responsibilities:

• Conduct routine and non-routine analysis of raw materials, in-process samples, and finished products following company Quality Management System and Standard Operating Procedures to ensure compliance with established specifications.
• Maintain accurate and detailed records of all testing procedures, results, and any deviations encountered during analysis.
• Identify opportunities for improvement and contribute to the implementation of best practices within the Quality department.
• Ensure laboratory instruments are calibrated and maintained in compliance with company standards.
• Monitor and manage inventory levels of laboratory supplies and reagents.
• Draft new and update existing SOPs to reflect changes in processes, instrumentation, or regulations.
• Assist with internal and external audits as needed.
• Perform Environmental Services sampling and monitoring as required.
• Collaborate with the Process Development and Quality teams to assist in the development and validation of new analytical methods.
• Investigate and resolve quality-related issues and product non-conformances.

Requirements & Qualifications:

• BA/BS in biology, biochemistry, or related field
• 1-3 YOE in industry highly preferred
• Preferred experience with analytical techniques such as HPLC, ELISA, UV-Vis spectroscopy, endotoxin determination, gel electrophoresis
• Excellent attention to detail and organizational skills
• Passionate, high-energy individual with a track record of achieving positive results.
• Strong analytical and problem-solving skills to troubleshoot and investigate deviations or non-conformances.

Desired Competencies:

• "A-Player Mentality": Goal-oriented and self-motivated. Hungry to make an impact. Seeks responsibility, no matter the ask.
• Outstanding verbal and written communication skills. Can present ideas with logic, efficiency, and clarity in both written and oral format. Active listening skills.
• Integrity and accountability. Takes responsibility for actions, both good and bad.
• Team player and collaborative mindset: Actively seeks and supports the success of other team members. Coachable mindset, open to learning, and seeking feedback.
• Demonstrates high "emotional intelligence."