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.
- 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).
- 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.
- 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.
- Participate in work scheduling, planning and support.
- 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)
- 1-3 years chemistry experience working in the life sciences industry.
- Previous experience supporting testing and release of raw materials and finished products.
- Excellent analytical capabilities.
- Strong team player with good communication skills across all levels within the organization.
- Shows a high degree of self-driven initiative and innovation.
- Working knowledge of MS Office.
- Strong technical and organizational skills with meticulous approach to quality of work, and time management.
- BS or MS in a life sciences discipline is required.
- Working knowledge of GMP and ISO standards.
- High Performance Liquid Chromatography (HPLC) is required.
- Gas chromatography (GC)
- Spectrophotometer (UV-Vis)
- Fourier transform infrared (FT-IR)
In addition to competitive compensation, we offer a comprehensive benefits package including:
401K plan with employer match
PPO and HMO medical insurance plan availability
Company paid dental and vision insurance
Company paid short-and long-term disability
Company paid life insurance
Company paid holidays
Generous paid time off allowances
Employee referral bonus
Employee gym reimbursement program
Employee recognition program