Scientist II, QC CQVPosition SummaryThe Scientist II, QC CQV is responsible for the qualification, validation, maintenance, administration, and lifecycle management of QC laboratory instruments, computerized systems, and laboratory software applications. This role ensures laboratory systems remain compliant with regulatory requirements, data integrity expectations, and GMP quality standards while supporting efficient and reliable laboratory operations. The position serves as a technical resource for equipment qualification, computerized system validation, software administration, data integrity oversight, and continuous improvement initiatives within the Quality Control organization.
Minimum QualificationsEducation and Experience- Bachelor's degree in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Computer Science, Engineering, or a related scientific discipline with a minimum of 4 years of relevant industry experience; or
- Master's degree in a related scientific discipline with a minimum of 2 years of relevant industry experience.
- Experience supporting Quality Control laboratories in a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.
- Experience with laboratory computerized systems, analytical instrumentation, and validation activities preferred.
Knowledge, Skills, and Abilities- Strong verbal and written communication skills and excellent interpersonal skills.
- Strong technical and scientific writing abilities.
- Critical thinking, analytical reasoning, and problem-solving skills.
- Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Visio.
- Working knowledge of GMP, GDP, ALCOA+ principles, and Data Integrity requirements.
- Knowledge of applicable regulations and guidance, including:
- 21 CFR Part 11
- EU GMP Annex 11
- GAMP 5
- Data Integrity guidance documents
- Experience with analytical laboratory equipment qualification and lifecycle management, including:
- HPLC/UPLC systems
- Capillary Electrophoresis (CE)
- iCIEF systems
- Spectrophotometers
- SoloVPE systems
- Endotoxin testing systems
- Laboratory balances, pipettes, refrigerators/freezers, and supporting laboratory equipment
- Experience with laboratory software applications such as:
- Empower CDS
- SoftMax Pro
- 32 Karat
- LabX
- EndoScan-V
- LIMS
- Microsoft Excel validated spreadsheets
- Experience supporting deviations, CAPAs, change controls, investigations, risk assessments, and regulatory inspections is preferred.
- Experience serving as a System Administrator or Laboratory Administrator is preferred.
Essential Duties and ResponsibilitiesInstrument and Equipment Lifecycle Management- Develop, coordinate, and execute calibration, preventive maintenance (PM), qualification, periodic review, and repair activities for QC laboratory instruments and equipment.
- Coordinate vendor service activities and work closely with Facilities & Engineering, Validation, IT, and QC functional groups to facilitate equipment maintenance and repair.
- Review calibration, qualification, maintenance, and repair documentation to ensure compliance with GMP requirements and site procedures.
- Support equipment lifecycle management activities from acquisition through retirement, including commissioning, qualification, operation, maintenance, and decommissioning.
- Maintain accurate equipment records and ensure timely completion of scheduled activities.
Qualification and Validation- Lead or support Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and periodic review activities for laboratory instruments and systems.
- Author, review, approve, and manage qualification and validation documentation, including:
- Validation Plans
- User Requirements Specifications (URS)
- Functional Specifications
- Risk Assessments
- IQ/OQ/PQ Protocols
- Validation Summary Reports
- Ensure qualification and validation activities are executed in accordance with regulatory requirements, GAMP principles, and company procedures.
- Support implementation and qualification of new laboratory equipment, computerized systems, and software applications.
Computerized System Administration- Serve as System Administrator for laboratory software and computerized systems, as assigned.
- Manage user accounts, user roles, permission levels, password controls, electronic signatures, and system configurations.
- Perform audit trail review activities and system health checks in accordance with site procedures.
- Support backup, restore, archival, disaster recovery, and business continuity activities.
- Conduct periodic access reviews and ensure compliance with data integrity requirements.
- Ensure computerized systems remain in a validated and inspection-ready state throughout their lifecycle.
Laboratory Software Validation and Administration- Lead or support software validation activities for laboratory applications including Empower, SoftMax Pro, 32 Karat, LabX, EndoScan-V, LIMS, and other laboratory software.
- Coordinate software installation, upgrades, patches, migrations, and retirement activities.
- Evaluate software changes through risk assessment and change management processes.
- Collaborate with Validation, IT, vendors, and business stakeholders to ensure compliant software implementation and operation.
Data Integrity and Compliance- Lead or support Data Integrity initiatives throughout the QC organization.
- Conduct and coordinate periodic Data Integrity self-assessments and system reviews.
- Ensure audit trail review programs are executed according to established requirements.
- Support internal audits, client audits, regulatory inspections, and quality systems assessments.
- Participate in deviation investigations, CAPAs, change controls, risk assessments, and effectiveness checks.
- Identify compliance gaps and drive remediation actions to maintain regulatory readiness.
Empower and Laboratory Data Systems Support- Serve as administrator for Empower Chromatography Data System (CDS) and associated infrastructure as assigned.
- Support creation and maintenance of projects, user accounts, user groups, custom fields, reports, and system configurations.
- Support data backup, archive, restore, and data lifecycle management activities.
- Participate in Empower and laboratory software upgrades, migration projects, and periodic reviews.
- Support troubleshooting and issue resolution related to laboratory software applications.
LIMS Administration and Computerized Systems Support- Support daily administration and maintenance of LIMS and other QC computerized systems.
- Manage master data configuration, user permissions, workflows, and system settings.
- Participate in system enhancement projects and cross-functional process improvement initiatives.
- Collaborate with IT, Validation, and business stakeholders to improve system functionality and efficiency.
- Support user acceptance testing, system configuration testing, and software implementation projects.
Continuous Improvement and Digital Transformation- Lead and support continuous improvement initiatives focused on laboratory efficiency, compliance, automation, and digital transformation.
- Identify opportunities to streamline laboratory processes through technology and system enhancements.
- Support cross-site alignment and harmonization initiatives for laboratory systems and CQV practices.
- Develop implementation plans, timelines, and project strategies for new equipment and software deployment.
Training and Technical Support- Develop and deliver training programs related to laboratory equipment, computerized systems, data integrity, and metrology.
- Provide technical support and guidance to laboratory users on instrument, software, and system-related issues.
- Support onboarding and training of new employees regarding laboratory systems and compliance requirements.
- Mentor junior team members and promote knowledge sharing within the organization.
Additional Responsibilities- Support business continuity and operational priorities as required.
- Maintain awareness of evolving industry regulations, guidance, and best practices.
- Perform other duties as assigned by management.
Preferred Qualifications- Experience administering Empower CDS, SoftMax Pro, LabX, LIMS, or other GMP laboratory systems.
- Experience with Data Integrity programs and audit trail review processes.
- Experience supporting regulatory inspections and client audits.
- Experience leading laboratory software implementation or digital transformation projects.
- Experience working within global, multi-site organizations and supporting harmonization initiatives.
- Project management experience and ability to manage multiple priorities simultaneously.
