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Quality Assurance Specialist

2 months ago

SaintBauzilledePutois, Occitanie, United States Akron Bio Full time
Job Title: Quality Control Chemist

Akron Bio is a leading manufacturer of advanced therapy components and raw materials for cell therapy discovery, development, and commercialization. We are seeking a highly motivated Quality Control Chemist to join our expanding team.

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.
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.