Analyst, Quality Control
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:
• Perform testing for incoming materials, in-process, and final products, as well as stability studies, in accordance with SOPs and customer specifications.
• Conduct method verification and validation for analytical procedures to ensure accuracy, precision, and reliability in testing processes.
• Collaborate regularly with cross-functional teams, including development, production, and quality, to ensure alignment on technical and operational goals.
• Perform instrument calibrations, qualifications, and preventive maintenance, ensuring the cleanliness and upkeep of laboratory equipment.
• Perform routine Testing as assigned including Environmental monitoring and WFI monitoring.
• Initiate and manage stability studies, including drafting protocols and reports.
• Write and revise Standard Operating Procedures (SOPs), validation protocols, and method validation documents to ensure compliance with regulatory standards.
• Prepare Certificates of Testing and Certificates of Analysis for finished products.
• Analyze and trend in-process and release data to identify improvement opportunities.
• Recommend and implement new testing methods to improve efficiency and accuracy.
• Foster an environment that encourages proactive problem-solving both individually and within teams.
• Troubleshoot and resolve routine issues, interpreting data based on experience and established lab standards.
• Adhere to SOPs and cGMP guidelines, ensuring compliance with ancillary material regulations.
• Execute tasks with minimal supervision and contribute to a culture of operational excellence.
• Perform additional duties as assigned.
Requirements:
• Education: Bachelor’s degree in chemistry, Biochemistry, Biology, or a related scientific discipline.
• Minimum of 3 to 4 years of relevant experience in a laboratory setting.
• Hands-on experience with HPLC/UPLC product testing is required. Empower software proficiency preferred.
• Proficiency with one or more of the following analytical instruments: UV spectrophotometer, IR spectroscopy, plate reader, and densitometer.
• Experience with molecular assays such as qPCR, sequencing, and ELISA is highly preferred.
• Ability to perform complex calculations including dilutions, fractions, decimals, and percentages.
• Experience in quality organizations supporting production, testing, release, and distribution of cGMP products.
• Familiarity with conducting investigations (deviations, out-of-specifications) related to testing procedures.
• Attention to Detail: Strong attention to detail with excellent time management and organizational skills.
• Pressure Management: Ability to work efficiently under pressure, prioritize multiple assignments, and meet deadlines in a dynamic, fast-paced environment.
• Independence: Self-motivated and capable of working independently while maintaining high standards of quality.
• Communication Skills: Excellent verbal communication skills with a strong customer service orientation.
• Software Proficiency: Basic knowledge of Word, Excel, and other laboratory software.
• Regulatory Compliance: Strong adherence to regulatory compliance and safety requirements, including GMPs, SOPs, and other related documentation such as logbooks.
EOE/DFW
Pharmaceutical Manufacturing and Biotechnology Research
Science and Research
Full-time