QC Supervisor

Job Overview

Key Stakeholders: Internal

Key Stakeholders: External

Reporting Structure

Essential Duties And Responsibilities

• Lead the QC Analysts in daily operational workflow by efficient allocation of resources.
• Perform a wide variety of activities to establish and ensure compliance with quality systems, quality procedures and policies and regulatory requirements to facilitate compliance with the agencies and customers.
• Develop, implement, and maintain programs and processes to ensure high quality products and compliance with IHC, cGMP, GLPs and a safe & clean lab operation.
• Responsible for the maintenance of QC Lab documentation SOP’s, methodology, specifications, calibrations sheets, logbooks, etc. through change control.
• Lead or participate in focused deviation cross-functional investigations, improvement projects and other initiatives.
• Review and approve QC Lab’s GMP test and lab operational documents.
• Perform the role of QC Lab Representative in coordinating, deviations, investigating and assessing Change Control Requests (CCR’s), as designated within this process.
• Identify Continuous Improvement Opportunities and perform their implementation.
• Implement management’s strategies and activities related to assuring compliance with regulations and ensure the company’s data integrity.
• Provide support for QC operations information during agency inspections as requested by Quality head.
• Manage all quality processes through SAP inventory management system.
• Batch production & in process samples testing record review and approval for release.
• Retains & Stability testing program oversight.
• Incoming Raw Materials and labeling materials approval.
• Quality systems support, including but not limited to: Investigation Support, Labeling, complaints, document control, training, CAPAs & Annual Product Reviews.
• Participates in product development support, including but not limited to: Methodology Transfers, Stability program, project management, and oversight of special studies supporting regulatory filings, data/record retrieval for regulatory submissions.
• Prepare protocols, reports, metrics trend reporting, validation, logs & other documentation as needed.
• Maintains all QC Lab equipment in proper operational state, calibrated and qualified to include the equipment operating software packages.
• Other quality activities in support of the product as necessary & agreed upon.
  

Key Competencies

• Well-organized and detailed oriented professional, with strong verbal and written communication skills
• Critical Thinking — using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems
• Excellent customer service skills and professional demeanor at all times to interface effectively with all internal and external customers
• Creative and able to present various solutions
• Energetic, enthusiastic, and motivational disposition
• Maintain confidentiality
• Coaching skills - Ability to lead and develop Quality team at the site
• Proficiency with computer office tools (Word, Excel, Outlook & scientific databases, etc.) is required.
• Ability to lead the QC Analysts in a fast-paced environment, manage priorities & maintain timelines for multiple projects is essential.
  

Education / Experience

• B.S. in Chemistry or related discipline is required.
• Minimum 5 years’ experience working in a pharmaceutical manufacturing laboratory environment.
• Minimum 3 years of supervisory experience in a pharmaceutical manufacturing laboratory environment.
• Lab testing in an environmentally controlled manufacturing facility.
• Hands-on experience of quality systems in a GxP environment, and direct experience with FDA, MHRA and other health authority inspections
• Good experience of handling DI breaches and awareness of requirements
• Good knowledge of international regulations & audit experience a plus.
  

• Job Identification 9130
• Job Category Quality Control
• Posting Date 07/22/2025, 03:47 AM
• Job Schedule Full time
• Locations 3950 Schelden Circle, Bethlehem, PA, 18017, US