QA Associate III

Johnson & Johnson

. Provide end-to-end quality oversight of GMP R&D GxP laboratories supporting analytical testing of commercial and clinical biotherapeutic products .

Posted 10/22/2026full-timeMalvern • Pennsylvania • United StatesMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GMP regulations, quality oversight, and analytical method validation within biotherapeutic product environments. Proficient in managing quality systems, ensuring compliance, and leading process improvements in regulated manufacturing settings.

Highest-signal resume keywords

GMP RegulationsQuality OversightAnalytical Method ValidationRegulatory Inspection ProcessesQuality Risk Assessments

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Support in Clinical ManufacturingDocument ReviewData IntegritySOP Review and ApprovalAnalytical Instrument Lifecycle ManagementChange Control EvaluationCorrective and Preventive ActionsProcess Improvement ActivitiesRaw Material ReleaseGxP Laboratory Oversight

Soft Skills

Excellent Communication SkillsAttention to DetailTeam CollaborationIndependent Project LeadershipAdaptability to Shifting Priorities

Tools & Technologies

CMMS SystemsSAPMaximoElectronic Laboratory Notebook SystemsBioviaELIMS

Industry Keywords

BiotechnologyPharmaceutical IndustryCGMPFDA GuidanceEU GuidanceGLP RegulationsBiologicsAdvanced TherapiesRegulated Manufacturing EnvironmentQuality Systems

Tech Stack

Tools & technologies

Spring

About the role

Key responsibilities & impact

Provide end-to-end quality oversight of GMP R&D GxP laboratories supporting analytical testing of commercial and clinical biotherapeutic products
Provide direct clinical and commercial supply chain support through raw material release
Liaise with internal quality organizations to standardize policies, practices, and procedures
Partner with Research & Development and Supply Chain teams on analytical method qualification, validation, and transfer
Collaborate with business partners on process development studies
Perform scheduled oversight of R&D GxP laboratories and warehouse
Review and approve raw material and critical reagent release across the Janssen global network
Review and approve SOPs, work instructions, validation protocols and reports, and technical studies
Ensure non-conformances are investigated and corrective/preventive actions are implemented
Support change controls by evaluating changes, assessing impact, and providing quality input
Provide quality oversight of analytical instrument lifecycle management, including qualification, release, maintenance, and calibration
Ensure data integrity and compliance with laboratory operations, SOPs, data recording, and equipment requirements
Lead process improvement activities and implement changes with partners
Support site inspections and inspection readiness; ensure laboratories are audit ready
Support data integrity efforts
Perform other duties as assigned

Requirements

What you’ll need

Bachelor’s Degree required, preferably in Engineering, Biology, Biochemistry, Microbiology, Chemistry, or relevant scientific/equivalent technical field
Minimum 4 years of experience in a regulated manufacturing environment required, preferably in biotechnology or pharmaceutical industry
Ability to maintain written records in paper-based and computerized quality systems
Ability to work independently and lead complex projects/issues with minimal supervision
Ability to work in a team environment
High degree of accuracy and attention to detail
Excellent interpersonal, oral, and written communication skills
Solid understanding of cGMP regulations and FDA/EU guidance related to biologics or advanced therapies required
Experience with quality support in clinical/GMP manufacturing or GxP laboratories preferred
Working knowledge of GLP regulations preferred
Prior supervisory experience is a plus
Experience with CMMS systems such as SAP and Maximo, and electronic laboratory notebook systems such as Biovia and eLIMS preferred
Experience performing and leading quality risk assessments preferred
Experience with document reviews and regulatory inspection processes preferred
Ability to prioritize daily business needs and adapt to shifting priorities preferred
Willingness and ability to travel up to 50% domestically to the Janssen site in Spring House, PA

Benefits

Comp & perks

Equal Opportunity Employer
Inclusive interview process and reasonable accommodation support for applicants with disabilities