Quality Control Supervisor Job Listing at Kelly Services in Montgomery, NJ (Job ID US3583227_BH9891814)

Description

Senior Quality Control / Quality Systems Consultant
Looking for a quality professional with over 10 years of experience in the pharmaceutical and biotechnology industry, specializing in Quality Control (QC), Quality Systems, Analytical Method Validation, and Global Specification Management. Demonstrates proven expertise in leading laboratory operations, managing cross-functional teams, and driving global standardization and digital transformation initiatives within highly regulated environments.
Education Requirement:
bachelor's degree or higher in Chemistry or a related scientific discipline is required. Key Responsibilities:

• Oversee and coordinate daily equipment qualifications in QC laboratories, collaborating with cross-functional teams to ensure timely execution.
• Lead analytical method validations, managing project timelines, resource allocation, and testing execution.
• Author and review technical documentation, including SOPs, test methods, validation master plans, and analytical reports in compliance with regulatory requirements.
• Support IQ/OQ/PQ execution, calibration activities, and overall lab readiness in coordination with internal departments.
• Provide oversight for change control processes, including authoring and reviewing documentation in systems such as TrackWise and Veeva Vault Quality Docs.
• Lead the digital transformation of QC systems as Product Owner for Empower CDS, managing a global cross-functional team using Agile project management practices.
• Manage operations in a high-throughput stability testing lab, leading a team of analysts and implementing Lean Lab and 5S principles to increase productivity and reduce costs.
• Conduct investigations (OOS, deviations), perform risk assessments and root cause analyses, and implement CAPAs in alignment with cGMP and data integrity standards.
• Oversee data review and documentation compliance, developing and maintaining SOPs to meet evolving regulatory requirements.
• Coordinate stability programs end-to-end, including protocol updates, change control evaluations, and cross-functional collaboration with Regulatory, QA, and Supply Chain.
• Perform hands-on analytical testing for finished products, stability studies, and technical transfer, while reviewing data for regulatory filings and batch release.
• Provide technical leadership for LIMS and electronic data archiving systems, ensuring compliance with FDA and ICH guidelines during audits and inspections.
• Contribute to the creation and maintenance of product specifications for raw materials, APIs, packaging components, and finished products in accordance with USP, ICH, and CFR standards.

Tools & Systems:

• Empower CDS (Waters), TotalChrom
• TrackWise, LIMS, Veeva Vault Quality Docs, ComplianceWire

Key Areas of Expertise:

• Analytical Method Validation & Transfer
• Equipment Qualification (IQ/OQ/PQ); Change Control & CAPA Management
• Stability Program Oversight
• Data Integrity & ALCOA+ Principles
• GMP/GLP Compliance; Regulatory Submissions & Audit Readiness
• Laboratory Operations & Team Leadership

 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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