Quality Assurance Specialist

1 month ago


CombressouslesCôtes, Grand Est, United States Bell International Laboratories, Inc Full time
Job Overview

The Quality Assurance Specialist will be responsible for maintaining the integrity and dependability of products through comprehensive physical and chemical assessments, ensuring compliance with established specifications. This role involves supporting the organization's understanding of current Good Manufacturing Practices (cGMP) and employing Good Laboratory Practices (cGLP) for the evaluation of various samples, including raw materials, stability tests, product retention, in-process evaluations, and final products.

Key Responsibilities
  • Perform testing on raw materials, in-process samples, and finished products in alignment with cGLP and cGMP standards.
  • Adhere to Standard Operating Procedures (SOPs), testing methodologies, and approved protocols within the laboratory environment.
  • Revise and update SOPs as necessary to reflect current practices.
  • Collaborate with both internal teams and cross-functional partners to ensure timely completion of testing and product releases.
  • Oversee material flow in coordination with Planning and Scheduling departments.
  • Investigate and document all non-conformance issues; conduct thorough analyses of quality concerns through established internal processes to determine root causes and potential resolutions.
  • Maintain and organize all quality and process-related documentation, both in physical and digital formats.
  • Ensure accurate documentation of processes, product quality, and testing outcomes.
  • Communicate any quality-related issues and concerns promptly to relevant personnel to facilitate effective resolutions.
  • Effectively manage time and prioritize assigned projects.
Required Skills and Qualifications
  • Familiarity with laboratory equipment setup, operation, and standard laboratory techniques, including safe chemical handling.
  • Strong technical writing, verbal, and interpersonal communication skills.
  • Solid analytical capabilities, critical thinking, and problem-solving skills.
  • Ability to manage multiple responsibilities and meet deadlines efficiently.
  • Effective communication with colleagues at all organizational levels.
  • Capacity to work independently in a dynamic environment.
  • Willingness to adapt and grow with changing structures and processes.
  • Proficient in computer applications and Microsoft Office Suite.
Education and Experience Requirements
  • Associate or technical degree, or equivalent experience in quality-related fields.
Preferred Qualifications
  • Bachelor's degree in Chemistry, Biology, or a related discipline.
  • 0-2 years of experience in a manufacturing or Quality Control setting.
  • Understanding of FDA regulations, specifically 21 CFR parts 210 and 211.
Equal Employment Opportunity Statement

Bell International Laboratories, Inc. is committed to providing equal employment opportunities to all employees and applicants, prohibiting discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all aspects of employment, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.



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