QC Scientist

2 weeks ago


Tucker, United States Corbion Full time

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.
Essential Job Functions :
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.
Minimum Qualifications :
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
Preferred Qualifications:
Advanced degree in chemistry, engineering, or other relevant area
10+ years' experience in an FDA regulated environment.
Product stability protocols and execution experience
Physical Demands : The work is performed mainly in the QC Laboratory and Plant Operations Areas where PPE is required. Through the course of a typical workday, an individual in this position will perform the following activities:
Sits
Stands
Walks
Kneels
Bends
Reaches above and below the shoulders
Must be able to wear appropriate PPE; including safety glasses, safety shoes, and lab coats.
About Corbion Corbion is the global market leader in lactic acid and its derivatives, and a leading supplier of emulsifiers, functional enzyme blends, minerals, vitamins, and algae ingredients. We use our unique expertise in fermentation and other processes to deliver sustainable solutions for the preservation of food and food production, health, and our planet. For over 100 years, we have been uncompromising in our commitment to safety, quality, innovation and performance. Drawing on our deep application and product knowledge, we work side-by-side with customers to make our cutting-edge technologies work for them. Our solutions help differentiate products in markets such as food, home & personal care, animal nutrition, pharmaceuticals, medical devices, and bioplastics. In 2023, Corbion generated annual sales of €1,443.8 million and had a workforce of 2,727 FTE. Corbion is listed on Euronext Amsterdam. For more information: www.corbion.com Corbion is an equal opportunity employer and committed to a diverse workplace. All applicants will be considered equally without regard to race, color, ethnicity, veteran status, religion, national origin, marital status, political affiliation, age, sex, sexual orientation, handicapping condition, membership in an organization or any other non-merit factors. Corbion provides reasonable accommodation to applicants. EOE/M/F/Vet/Disabled
Corbion does not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers. All candidates must be submitted by approved Corbion vendors who have been expressly requested to make a submission by our Talent Acquisition team for a specific job opening. No placement fees will be paid to any firm unless such a request has been made by the Corbion Talent Acquisition team and such candidate was submitted to the Corbion Talent Acquisition Team.
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Medical Device, Chemistry, QC, Pharmaceutical, Facilities, Healthcare, Science, Quality, Operations