Job Description: This position functions as the technical and quality systems leader within QC Operations Support.
Responsibilities: - Perform Compendial Assessments.
- uthor and Review Technical Documents.
- Design and Coordinate Analytical Method Onboarding Activities.
- Lead Qualification of Critical Materials, Instruments, and Equipment.
- Oversee Change Control Management.
- Manage Corrective and Preventive Actions (CAPAs).
- Serve as Subject Matter Expert (SME).
- Collaborate Across Departments.
- Drive Continuous Improvement Initiatives.
- Conduct Data Trending and Analysis.
- Represent QC on Global and Local Projects.
- Perform Other Duties Assigned by Leadership.
Requirements: - 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.
