Quality Control Analyst

Company : LanceSoft Inc

Description:

• The role of the Senior Quality Control Specialist is to provide technical expertise and support for the Operational Support functions of the QC Laboratory.

Responsibilities (not limited to):

• Perform compendial assessments to ensure compliance with current regulatory requirements and pharmacopeia standards.
• Author and review technical documents, including protocols, standard operating procedures (SOPs), and analytical methodologies.
• Design and coordinate analytical method onboarding activities, including execution planning, training, and documentation.
• Lead and manage the qualification of critical materials, analytical instrumentation and equipment, ensuring fitness for use in analytical testing.
• Oversee change control management processes, including risk assessment, documentation, and implementation.
• Manage Corrective and Preventive Actions (CAPAs) related to analytical processes and support timely closure of quality events.
• Act as a Subject Matter Expert (SME) by providing technical guidance and troubleshooting support to laboratory testing teams.
• Collaborate effectively across departments to ensure alignment and successful execution of cross-functional initiatives.
• Identify and drive continuous improvements in analytical methods and laboratory workflows to enhance efficiency and compliance.
• Conduct data trending and analysis of laboratory processes and analytical performance on a routine basis to identify trends and areas for improvement.
• Collaborate as a QC representative with global teams on both global and local projects and take the initiative for improvements.
• All other duties as assigned by Leadership
• Microbiology experienced is NOT needed for this role.

Education and Experience Requirements:

• Requires bachelor's degree in science, engineering or other related technical field. 4+ years of related experience in pharmaceutical or similar regulated industry.

Key Skills, Abilities, and Competencies

• Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs.
• Must have the ability to manage multiple tasks and responsibilities for the QC Lab.
• Must have the ability of managing complex projects and resolving complex lab issues.
• Must possess excellent technical and interpersonal skills, and be able to communicate with all level personnel and regulatory authorities.
• Should have advanced knowledge in Statistical Analysis and cGMP standards. Strong leadership, project and people management skills, and ability to make critical decisions.
• Strong understanding of business and/or industry.

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