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Chemist, Biotech Quality Control

Employer
Akron Biotech
Location
Boca Raton, FL
Start date
Sep 26, 2022

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Discipline
Quality, Science/R&D, Biotechnology, Chemistry
Required Education
Bachelors Degree
Position Type
Full time
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Job Details

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
 
  • Oversee all aspects of Akron’s QC processes ensuring products meet company standards.
  • Ensure compliance with new and existing quality standards and regulations (i.e.: 21CFR, GMP. ISO, EP).
  • Identify and implement effective processes and contribute to the growth of the department.
  • Provide QC support to projects from planning to completion and promptly resolves discrepancies that may arise.
  • Coordinate and provide quality control scheduling, planning and support.
  • Coordinate employees’ activities and effectively prioritize and organize duties and resources to meet multiple deadlines.
  • Conduct or assist with quality control training.
  • Conduct tests and experiments, write quality control reports, ensure customer support, and perform statistical analysis.
  • Maintain effective QC processes, including but not limited to method validation, trending, OOS, routine testing, and root cause analysis investigations.
  • Identify and implement action to correct adverse trend within areas of responsibilities. Determine data-driven solutions and implement quality control improvement plans.
  • Initiate and/or review method validation, OOS, QC testing results, etc.
  • Lead, support, and collaborate with other groups for timely investigation, identification, and implementation of most appropriate corrective and preventive actions utilizing risk management tools (i.e., FMEA, Fishbone).
  • Perform other duties as assigned.
  • Ensuring compliance with current regulations (applicable GMP and ISO standards).
  • Maintain Stability program (i.e.: protocols, testing schedules, reports)


Requirements
 
  • Minimum of 5 years working in the biopharmaceutical, cellular therapy, or gene therapy industries.
  • Experience in Quality Organizations supporting testing and release of raw materials and finished products.
  • Excellent trouble shooting, problem-solving and decision-making skills.
  • Strong team player with good communication skills across all levels within the organization.
  • Superior English writing skills (Technical Writing) and able to convey ideas concisely.
  • Results oriented – highly motivated and able to work independently to achieve objectives.
  • Shows a high degree of self-driven initiative and innovation.
  • Strong computer skills – working knowledge of software functions (i.e., MS Word, Excel, and Power Point) and ability to work well with Internet Explorer and Outlook and quality management systems.
  • Strong observational and organizational skills with meticulous approach to quality of work, and time management.
  • Minimum BA/BS in science, Biochemistry, Medical Technologist, or equivalent discipline.
  • Working knowledge of GMP and ISO standards.
  • High Performance Liquid Chromatography (HPLC) Required experience.
  • Gas chromatography (GC) Preferred experience 
  • Spectrophotometer (UV-Vis) Preferred experience
  • SDS-PAGE Preferred experience 
  • Densitometer Preferred experience 
  • Fourier transform infrared (FT-IR) Preferred experience 
EOE/DFW

Company

Akron Biotech is an innovative biotechnology company with a strategic focus on supplying GMP-qualified raw materials and services to the regenerative medicine industry. An ISO 13485-certified company operating in line with cGMP guidelines and international standards, Akron provides advanced therapy developers the scale, compliance, and regulatory support to develop novel treatments.

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Find Us
Website
Phone
+1 561-750-6120
Location
6353 West Rogers Circle
Suite 2
Boca Raton
FL
33487
United States
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