Quality Control Analyst
Description:
Education and Experience Requirements:
- The role of the Senior Quality Control Specialist is to provide technical expertise and support for the Operational Support functions of the QC Laboratory.
- 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.
- 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.
