Quality Control Analyst I

Role Summary

Quality Control Analyst I responsible for performing and reviewing analyses of in-process, release, and stability samples in accordance with cGMP, site and corporate procedures and policies. Involves transfer of technology and processes in line with project plans and timelines.

Responsibilities

• Accuracy and scientific soundness of lab data
• Environmental compliance
• GMP compliance of laboratory
• Maintain testing proficiency for methods
• Timeliness of lab results and investigations
• Analysis of samples
• Supports deviations
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities, as assigned

Qualifications

• Minimum of a Bachelor‚Äôs degree in chemistry or relevant field required, or equivalent combination of education and experience
• May consider an Associate‚Äôs degree with minimum three years of experience in a clinical or industrial/pharmaceutical laboratory
• May consider a high school diploma or GED with minimum five years of experience in a clinical or industrial/pharmaceutical laboratory
• Minimum of one year of experience in a clinical or industrial/pharmaceutical laboratory required
• Ability to author scientific and technical reports is a plus
• Ability to perform routine testing per SOP and GMP standards is a plus
• Basic troubleshooting for laboratory equipment is a plus
• Knowledgeable in GMP and laboratory techniques is a plus
• Attention to detail
• Strong communication skills (verbal and written) a plus
• Experience with chemistry analysis of tablets including UPLC and dissolution is desired

Skills

• Laboratory data analysis
• GMP and SOP compliance
• Analytical methods and instrumentation
• Technical writing and reporting

Education

• Bachelor‚Äôs degree in chemistry or related field (preferred)

Additional Requirements

• Physical requirements include moving equipment up to 33 pounds, close precision work, and potential exposure to odorous or hazardous materials