What are the responsibilities and job description for the Senior Quality Control Specialist position at Katalyst CRO?
Job 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
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.