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Quality Control Chemist
2 months ago
Position: Quality Control Chemist
Company: DivIHN Integration Inc
Location: Round Lake, IL
Duration: 12 Months
Important Note: Candidates must not have allergies to Penicillin, Cephalosporin, or related substances.
Role Summary:
The Quality Control Chemist will be responsible for conducting analytical evaluations, validation, and transfer of testing methodologies that support pharmaceutical parenteral products. The primary focus will be on stability assessments, while also contributing to new product development and ongoing product maintenance initiatives.
Key Responsibilities:
- Perform essential chemical and physical analyses on stability samples of finished products. Additional support may be required for testing raw materials and samples from various stages of manufacturing.
- Review and validate test data, ensuring compliance with documentation standards. Utilize LIMS or other computerized systems for data management.
- Employ advanced laboratory instruments and computer systems for data collection and analysis. May involve system ownership or validation tasks.
- Conduct sophisticated chemical assays that require a high level of analytical expertise and a solid understanding of chemistry principles. Ensure timely completion of all testing, including special projects.
- Maintain data integrity and adhere to company SOPs, as well as FDA, cGMP, and QSR regulations.
- Investigate discrepancies and document exceptions as necessary.
- Collaborate with cross-functional teams to address challenges, enhance efficiency, and improve product quality.
- Ensure laboratory safety standards are met, perform equipment maintenance and calibration, and troubleshoot basic instrument issues.
Qualifications:
- Strong oral and written communication skills, with a keen attention to detail.
- Proficiency in advanced wet chemistry, volumetric preparation techniques, and instrumental analysis methods.
- Demonstrated ability to train others and lead projects effectively.
- Ability to manage multiple tasks efficiently and meet deadlines.
- Competence in writing and computer skills is essential.
- Ability to interpret data and provide recommendations for resolving technical issues.
Physical Requirements:
- Ability to handwrite and utilize computers for the majority of the workday.
- Capability to transfer materials, mix solutions, and conduct laboratory tests.
- May require prolonged standing and the ability to lift up to 10 pounds regularly.
- Work involves exposure to chemicals and biological materials.
Education and Experience:
Bachelor's degree in a relevant scientific field (e.g., chemistry, pharmaceutical sciences) with analytical chemistry coursework and a minimum of 2 years of experience in a laboratory setting.
Experience with analytical chemistry instrumentation (e.g., HPLC, UPLC, UHPLC) is required, with HPLC experience being essential. Familiarity with Empower software and Electronic Lab Notebooks is preferred.
Experience in a pharmaceutical GMP laboratory and stability study execution is advantageous.
About DivIHN: DivIHN Integration Inc specializes in IT Asset Performance Services, offering Professional Consulting, Custom Projects, and Resource Augmentation to clients across the Mid-West and beyond. Our organization is built on the principles of Standardization, Specialization, and Collaboration.
DivIHN is committed to equal opportunity employment and does not discriminate against any employee or qualified applicant based on race, color, religion, gender, age, national origin, disability, marital status, sexual orientation, or military status.
