Bachelor's degree in science, engineering, or related field
4+ years of experience in pharmaceutical or related regulated industry
Strong Quality Control (QC) Microbiology experience preferred
Knowledge of laboratory operations and government regulations
Excellent technical, interpersonal, and communication skills
Ability to manage multiple tasks and complex projects
Strong leadership and decision-making skills
Responsibilities
Perform compendial assessments for regulatory compliance
Author and review technical documents and SOPs
Design and coordinate analytical method onboarding activities
Lead qualification of critical materials and analytical equipment
Oversee change control management processes
Manage Corrective and Preventive Actions (CAPAs)
Act as a Subject Matter Expert (SME) for laboratory teams
Collaborate across departments for cross-functional initiatives
Drive continuous improvements in analytical methods
Conduct data trending and analysis for performance improvement
Engage in global and local project collaborations
Benefits
Opportunity to work in a technically advanced environment
Involvement in cross-functional global projects
Focus on continuous improvement initiatives
Exposure to regulatory compliance standards
Engagement with a diverse team of professionals
Full Job Description
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:
Perform compendial assessments to ensure compliance with current regulatory requirements and pharmacopeia standards.
uthor 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.
ct 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.
ll other duties as assigned by Leadership 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.
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.
