Overview The QC Laboratory Operations Lead is responsible for managing core Quality Control support functions at WuXi STA's drug product manufacturing facility in Middletown, DE. This role provides ...
Overview The QC Laboratory Operations Lead is responsible for managing core Quality Control support functions at WuXi STA's drug product manufacturing facility in Middletown, DE. This role provides ...
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GMP QC Systems Consultant
Frankford, DE · On-site
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Implement new QC metrology and verify the performance of existing QC metrology in accordance with statistical techniques including Measurement System Analysis. * Serve as a technical expert and first ...
Implement new QC metrology and verify the performance of existing QC metrology in accordance with statistical techniques including Measurement System Analysis. * Serve as a technical expert and first ...
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Implement new QC metrology and verify the performance of existing QC metrology in accordance with statistical techniques including Measurement System Analysis. * Serve as a technical expert and first ...
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Quality Control Technician - Day Shift
Newark, DE · On-site
$18.25 - $23.50/hr
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PLEASE NOTE: THIS IS AN INTERNAL JOB POSTING. ONLY CURRENT C&B COMPLETE CLEANING AND CONSTRUCTION EMPLOYEES WILL BE CONSIDERED FOR THIS POSITION. EXTE.
PLEASE NOTE: THIS IS AN INTERNAL JOB POSTING. ONLY CURRENT C&B COMPLETE CLEANING AND CONSTRUCTION EMPLOYEES WILL BE CONSIDERED FOR THIS POSITION. EXTE.
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Quick apply
Senior Specialist, Sample Management QC
Newark, DE · On-site
$49K - $57K/yr
All QC activities are performed through document review, data verification, and system‑based checks. No laboratory or hands‑on QC testing is involved. The position requires extreme attention to ...
Senior Specialist, Sample Management QC
Newark, DE · On-site
$49K - $57K/yr
All QC activities are performed through document review, data verification, and system‑based checks. No laboratory or hands‑on QC testing is involved. The position requires extreme attention to ...
Quick apply
Senior Specialist, Sample Management QC
Newark, DE · On-site
$49K - $57K/yr
All QC activities are performed through document review, data verification, and system‑based checks. No laboratory or hands‑on QC testing is involved. The position requires extreme attention to ...
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The DNA Technician in the Quality Control Section at AFDIL assists in program maintenance and development at the direction of their Validation & Quality Control Manager. The DNA Technician may ...
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The DNA Technician in the Quality Control Section at AFDIL assists in program maintenance and development at the direction of their Validation & Quality Control Manager. The DNA Technician may ...
The DNA Technician in the Quality Control Section at AFDIL assists in program maintenance and development at the direction of their Validation & Quality Control Manager. The DNA Technician may ...
In alignment with the business strategy, we are seeking an entrepreneurial and highly analytical Senior IS Automation Quality Control Analyst to ensure the efficient delivery of high-quality business ...
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In alignment with the business strategy, we are seeking an entrepreneurial and highly analytical Senior IS Automation Quality Control Analyst to ensure the efficient delivery of high-quality business ...
In alignment with the business strategy, we are seeking an entrepreneurial and highly analytical Senior IS Automation Quality Control Analyst to ensure the efficient delivery of high-quality business ...
In alignment with the business strategy, we are seeking an entrepreneurial and highly analytical Senior IS Automation Quality Control Analyst to ensure the efficient delivery of high-quality business ...
In alignment with the business strategy, we are seeking an entrepreneurial and highly analytical Senior IS Automation Quality Control Analyst to ensure the efficient delivery of high-quality business ...
The DNA Technician in the Quality Control Section at AFDIL assists in program maintenance and development at the direction of their Validation & Quality Control Manager. The DNA Technician may ...
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... quality, or technical operations within a regulated environment. * Prior experience managing or ... Change control processes ISO9001:2015 Supply Chain Management & Risk principles Manufacturing ...
... quality, or technical operations within a regulated environment. * Prior experience managing or ... Change control processes ISO9001:2015 Supply Chain Management & Risk principles Manufacturing ...
Set up, operate, and maintain instruments used for manipulating, monitoring, and storing plasma products (Quality Control), supply management and determining when to release in FIFO process
Set up, operate, and maintain instruments used for manipulating, monitoring, and storing plasma products (Quality Control), supply management and determining when to release in FIFO process
Set up, operate, and maintain instruments used for manipulating, monitoring, and storing plasma products (Quality Control), supply management and determining when to release in FIFO process
Set up, operate, and maintain instruments used for manipulating, monitoring, and storing plasma products (Quality Control), supply management and determining when to release in FIFO process
Quality Control information
See Delaware salary details
$11.79 - $13.76
2% of jobs
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$16.94 is the 25th percentile. Wages below this are outliers.
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20% of jobs
The median wage is $19.40 / hr.
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$11
$21
$33
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What is the difference between Quality Control vs Quality Assurance?
| Aspect | Quality Control | Quality Assurance |
|---|---|---|
| Focus | Detecting defects in products or services | Preventing defects through process improvements |
| Activities | Inspections, testing, sampling | Process audits, standards development |
| Credentials | Often requires technical training or certifications in testing | Certifications like ISO, Six Sigma are common |
| Work Environment | Laboratory, production lines, manufacturing | Process development, documentation, audits |
While Quality Control focuses on identifying defects after production, Quality Assurance aims to prevent defects through process improvements. Both roles are essential for maintaining product quality, but they differ in approach and activities.
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QC Laboratory Operations Lead
Middletown, DE • On-site
Other
Re-posted 16 days ago
Job description
The QC Laboratory Operations Lead is responsible for managing core Quality Control support functions at WuXi STA's drug product manufacturing facility in Middletown, DE. This role provides leadership and oversight for Stability Program Management, Sample Lifecycle Management, Metrology and Laboratory Equipment Lifecycle Management, Inventory and Consumable Control Management, and critical laboratory electronic systems, like Empower and LIMS. The position ensures laboratory operations are adequately resourced, compliant with current GMP requirements, inspection-ready, and capable of supporting manufacturing, product release, and stability commitments. The QC Laboratory Operations Lead collaborates closely with QC Analytical, QC Microbiology, Manufacturing, Quality Assurance, Validation, Engineering, and Information Technology to ensure effective laboratory operations and continuous improvement.
Responsibilities
Stability Program Management
- Own and manage the site stability program, including study initiation, sample pulls, scheduling, storage, inventory tracking, and sample reconciliation.
- Ensure stability studies are executed in accordance with approved protocols, regulatory requirements, and client commitments.
- Coordinate stability chamber utilization, monitoring, qualification activities, and capacity planning.
- Maintain stability databases and ensure accurate tracking of all stability samples throughout the study lifecycle.
- Monitor program performance and ensure timely communication of upcoming testing requirements.
- Lead laboratory sample management operations from receipt through storage, distribution throughout the testing groups, reconciliation, retention, and disposal.
- Develop and/or maintain procedures governing sample custody, chain of custody documentation, and sample traceability.
- Manage sample logistics supporting release testing, stability testing, investigations, validation activities, and client requests.
- Ensure sample inventory systems are maintained accurately and support efficient laboratory workflows.
- Identify and implement improvements to sample handling processes that enhance compliance and operational efficiency.
- Oversee the full lifecycle management of laboratory equipment, including procurement, commissioning, qualification, calibration, preventive maintenance, repair, and retirement.
- Manage equipment scheduling to ensure continuous laboratory readiness and minimize downtime.
- Partner with Validation, Engineering, and vendors to support instrument qualification and maintenance activities.
- Ensure calibration and maintenance programs are executed within established due dates.
- Monitor equipment performance metrics and drive continuous improvement initiatives.
- Monitor vendor performance metrics and implement contingency plans where necessary to ensure there is no disruption to throughput.
- Maintain equipment inventory records and ensure compliance with applicable GMP requirements.
- Establish and manage laboratory inventory programs for reagents, consumables, reference standards, columns, and critical supplies.
- Monitor inventory levels and implement forecasting processes to ensure uninterrupted laboratory operations.
- Coordinate purchasing activities and maintain appropriate stock levels while minimizing waste and expired materials.
- Ensure materials are received, stored, qualified, and utilized according to approved procedures.
- Develop key performance metrics related to inventory utilization, availability, and cost management.
- Lead small team of dedicated contractors supporting consumable materials.
- Serve as business owner or system administrator for critical laboratory computerized systems, including LIMS, CDS, Electronic Laboratory Notebooks, and related GMP applications.
- Coordinate system access management, user administration, configuration changes, periodic reviews, and data integrity activities.
- Partner with IT, Quality Assurance, and system vendors to maintain system compliance and operational effectiveness.
- Support computer system validation activities and change control processes.
- Ensure regulatory compliance with data integrity requirements and maintain inspection readiness for all laboratory systems.
- Ensure laboratory operational processes comply with FDA, EMA, ICH, and applicable GMP regulations.
- Support investigations, deviations, CAPAs, change controls, and risk assessments associated with laboratory operations.
- Participate in internal audits, client audits, and regulatory inspections.
- Monitor compliance trends and implement preventive actions to reduce operational risk.
- Drive continuous improvement initiatives to improve efficiency, compliance, and employee engagement.
- Build, develop, and lead the Laboratory Operations team.
- Provide coaching, mentoring, training and career development opportunities for team members.
- Establish performance expectations and conduct routine performance evaluations.
- Manage staffing, resource allocation, and succession planning.
- Foster a culture focused on compliance, operational excellence, accountability, and continuous improvement.
Qualifications
Required Qualifications:
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related scientific discipline required; advanced degree preferred.
- Minimum 7 years of GMP pharmaceutical laboratory experience with at least 3 years in leadership or supervisory roles.
- Demonstrated experience managing laboratory operations, stability programs, sample management, metrology, equipment programs, or laboratory systems.
- Strong understanding of GMP regulations, data integrity principles (ALCOA+), and regulatory inspection expectations.
- Experience with LIMS, CDS, stability management software, inventory systems, and computerized system compliance.
- Proven ability to manage multiple priorities in a fast-paced pharmaceutical manufacturing environment.
- Strong organizational, communication, project management, and leadership skills.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
About WuXi AppTec
Sourced by ZipRecruiter
Industry
Health care and social assistance
Headquarters location
Shanghai , Shanghai, CN