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Senior Quality Control Specialist
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Senior
5 months ago
5 months ago
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:
- 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 Education and Experience.
- Requires bachelor's degree in science, engineering or other related technical field.
- 4+ years of related experience in pharmaceutical or similar regulated industry.
- Strong QC Microbiology experience preferred (testing, sampling, processes) 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.
Senior Quality Control Specialist · Katalyst Healthcares & Life Sciences