Analyst, Quality Control

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Job description

Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.

Responsibilities

• Interacts regularly with senior technical peers and colleagues in all departments especially in development, production, and quality.
• Creates and environment that encourages problem solving at the individual and team level.
• Develops new procedures and associated SOP's.
• Responsible for performing periodic checks on the production process to ensure compliance with customer requirements.
• Inspect and test incoming material, in-process product and final product as detailed in our SOPs, SDS sheets or working instructions to help ensure that our suppliers and our production process complies with established quality requirements.
• Perform general QC preventive equipment maintenance - maintains equipment calibrations and records equipment performance statistics monitoring performance trends. Contribute to maintaining lab and equipment cleanliness.
• Conducts in-house testing of products used for stability studies, parallel correlation studies and the general Laboratory and Instrumentation Maintenance.
• Prepare shipments of samples for outside testing (including required documents and labels).
• Prepare finished products Certificate of Analysis.
• Perform QC tests on raw materials and product samples - specific to assigned projects.
• Organize/analyze Akron's in process/release data.
• Assists in the recommendation of new methods for testing efficiency
• Performs duties in accordance with established laboratory standards. Evaluates, troubleshoots and solves routine problems. Interprets data based on knowledge and experience.
• Perform other duties as assigned.

Requirements:

• BS in Micro or Molecular Biology required.
• 4 or more years of relevant QC experience.
• Experience in quality organizations supporting production, testing, release and distribution of cGMP products.
• Should have practical experience with harvest, protein purification and characterization.
• Knowledgeable in scale up issues associated with protein purification process.
• High attention to detail with good time management and organizational skills.
• Ability to work well under pressure and prioritize assignments in a multi-task position.
• Motivated and able to work independently.
• Excellent verbal communication skills and people/customer service oriented.
• Basic knowledge of Word, Excel and Software Programs.
• Requires a strong adherence to regulatory compliance and safety requirements, involving GMPs, SOPs and other related documents such as log book.

EOE/DFW

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