Quality Control Specialist/ Scientist Full-time

General Summary and Purpose:

This role works as part of an interdisciplinary team to develop, optimize, transfer and validate characterization, in-process and release tests for the manufacturing of ice recrystallization inhibitor-based cryopreservation products.

 Duties and Responsibilities:

• Develops, optimizes, and validates analytical chemistry assays with minimum supervision.
• Supports the routine execution and troubleshooting of analytical assays
• Assists in the processing and analysis of data
• Maintains detailed records of all experiments performed
• Articulates and presents results to the project team
• Ensures QC project deliverables are met on time
• Ensure QC equipment maintenance and calibration is done in time
• Carries out ongoing lab sampling performing visual, dimensional, mechanical or chemical analyses of in-process materials, raw materials, final product and stability samples
• Supports the elaboration and updating of documentation to ensure that our company complies with GMP regulations and quality standards
• Assist in the development of needed records and standards and maintain accurate and detailed files, as required
• Participate in the development of product specifications

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the team member for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Requirements:

• Prior experience analyzing, summarizing & interpreting data is strongly preferred.
• Prior experience in the pharmaceutical or biotechnology industry is preferred.
• Experience writing and revising controlled documents is required.
• Able and willingness to follow detailed instructions and SOPs without deviating is required.
• Ability to keep and maintain a clean and orderly work environment is required.
• Excellent organizational skills are required
• Strong attention to detail is required
• Highly adaptability and responsiveness to new priorities is required
• Ability to work independently with minimal supervision.
• Must have good visual acuity and color perceptions, and manual dexterity.
• Effective written and oral communication skills.
• Team-oriented player, with a strong work ethic is required.
• Enthusiasm to tackle difficult problems, learn new technologies, and work in an exciting, high paced environment is a must.

Job Specifications

• BSc degree in analytical chemistry, biochemistry, or related discipline is required.
• 2+ years of relevant experience developing analytical assays is required
• 2+ years of relevant experience running and/or interpreting analytical assays, such as TLC, HPLC, GC and moisture analysis is required.
• GMP experience required
• Experience working in a lab required
• Microsoft Suite capabilities
• Experienced in Good Documentation Practices

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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