Corbion - Tucker, GA
posted about 1 month ago
About the position
At Corbion, we exist to champion preservation in all its forms, preserving food and food production, health, and our planet. In the medical and pharmaceutical market, Corbion is the market leader in the production of resorbable polymers and high-strength, degradable biocomposites for the medical device and pharmaceutical industry. Our resorbable polymers and biocomposites are used to produce orthopedic implants, drug delivery systems, and wound closure applications. We are now hiring a Quality Control (QC) Scientist for our facility in Tucker, GA. As our next QC Scientist, you will be responsible for performing laboratory analyses on raw materials, in-process samples, and finished products to ensure they meet established quality standards, adhering to Good Manufacturing Practices (GMP) guidelines. You will be conducting tests using various analytical techniques, documenting results meticulously, and identifying and reporting any quality issues to maintain product safety and compliance with regulations.
Responsibilities
- Performing analytical testing: Execute validated analytical methods on samples using techniques like HPLC, GC, ICP and other relevant methods to determine product quality parameters like purity, identity, and stability.
- Data analysis and interpretation: Review and interpret test results, identify any deviations from specifications ('out-of-spec' results), and initiate appropriate investigations to determine root cause.
- Documentation and record keeping: Maintain detailed and accurate laboratory notebooks, including raw data, calculations, and observations, in compliance with GMP regulations.
- Standard Operating Procedure (SOP) adherence: Follow established SOPs for all laboratory activities and ensure compliance with quality standards. Revise SOPs and methods as required.
- Equipment calibration and maintenance: Perform routine maintenance and calibration of laboratory instruments to maintain accuracy and reliability.
- Quality issue resolution: Investigate and document out-of-specification (OOT/OOS) results, propose corrective actions, and collaborate with relevant departments to address quality issues.
- Validation studies: Develop and execute analytical method validation protocols to ensure the reliability and robustness of testing methods.
- Training and development: Participate in ongoing training to stay updated on new analytical techniques, regulatory requirements, and quality standards.
Requirements
- Bachelor's degree in Chemistry, Biology, Microbiology, Engineering, or a related field
- 7 years' experience in an FDA regulated environment
- Method validation experience
- Excellent understanding of analytical chemistry principles and techniques.
- Experience with laboratory equipment like HPLC, GC, ICP, Titration and other relevant instruments
- Proficiency in data analysis and interpretation
- Excellent documentation and record-keeping skills
- Knowledge of GMP regulations and quality standards
- Ability to work independently and as part of a team
Nice-to-haves
- Advanced degree in chemistry, engineering, or other relevant area
- 10+ years' experience in an FDA regulated environment.
- Product stability protocols and execution experience
