What are the responsibilities and job description for the QC Analyst III - 239076 position at Medix?
Duties and Responsibilities :
Conduct microbiological in-process and release testing to support GMP manufacturing, including bioburden, growth promotion, and endotoxin testing.
Perform environmental monitoring within classified manufacturing areas, adhering to approved SOPs and cGMPs, including data review and support under dynamic conditions.
Collect and monitor utility samples throughout the facility.
Investigate deviations, manage CAPA processes, and participate in cross-functional activities to support the Quality Management System.
Author, edit, and review SOPs, forms, and other documentation within the document management system.
Lead departmental goals and act as an SME for QC Micro and EM activities.
Analyze and trend environmental monitoring data, generating conclusions for facility trend reports.
Engage in cross-functional projects to contribute to site development and improvements.
Education and Experience :
Bachelor’s degree in Microbiology, Biochemistry, Chemistry, or a related field.
A minimum of five (5) years of experience in a regulated QC laboratory, handling biological test samples.
Proficient in methods and systems used in biological QC laboratories.
Strong understanding of current Good Manufacturing Practices (cGMPs).
Knowledgeable in safety regulations and ensuring data integrity.
Expertise in troubleshooting HPLC equipment and software.
Desired Key Competencies :
Ability to thrive in a fast-paced environment, adapting workload based on shifting priorities with minimal direction.
Self-motivated, proactive in taking on additional responsibilities outside the initial job description to support department needs.
Strong interpersonal skills to interact effectively with individuals across various levels and functions.
Highly organized, detail-oriented, and meticulous in hands-on tasks.
Exceptional communication skills, both verbal and written, to collaborate in a team-oriented environment.
Proficient in MS Word and MS Excel.
Strong analytical and quantitative skills.
Alignment with and ability to support the company’s mission and values.
High ethical standards, demonstrating trustworthiness and reliability.
Positive, solution-oriented attitude with a willingness to adapt.
Able to navigate and drive change within the organization.
Resolves conflict constructively and positively.
Skilled at processing complex information to reach logical conclusions.
Innovates through creative solutions to challenges.
Effective at organizing and implementing group projects.
Energized by achieving excellence and accomplishments in the workplace.
Capable of performing well both independently and in a team setting.
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