QA Associate II

Johnson & Johnson

QA Associate II for Johnson & Johnson overseeing GMP manufacturing and quality assurance processes in clinical product development. Collaborating with research, supply chain, and business partners for compliance.

Posted 7/22/2026full-timeMalvern • Pennsylvania • 🇺🇸 United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GMP manufacturing processes, quality assurance, and regulatory compliance within the biotechnology or pharmaceutical industry. Proficient in document review, change management, and process improvement activities while maintaining high accuracy and attention to detail.

Highest-signal resume keywords

GMP ManufacturingQuality AssuranceRegulatory ComplianceDocument ReviewProcess Improvement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Batch Record ReviewControlled Document ApprovalRisk AssessmentChange ManagementCGMP RegulationsFDA GuidanceBiotechnology ManufacturingPharmaceutical ManufacturingQuality SystemsInspection Readiness

Soft Skills

Interpersonal CommunicationOrganizational SkillsTeam CollaborationAttention to DetailPositive Demeanor

Industry Keywords

BiologicsCell BankingLarge Molecule ManufacturingRegulated Manufacturing EnvironmentScientific Field

About the role

Key responsibilities & impact

Partner with Research & Development and Supply Chain teams to support GMP manufacture of clinical products, medias, and buffers.
Collaborate with business partners to support new product introductions.
Perform regularly scheduled oversight of manufacturing areas and on-call support as assigned.
Review and approve controlled documents including standard operating procedures, work instructions, and risk assessments.
Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans.
Perform batch record review and critical alarm review.
Support in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.
Support site inspections and inspection readiness activities.

Requirements

What you’ll need

A minimum of a Bachelor’s Degree is required with a focus in Engineering, Biology, Biochemistry, Microbiology, Chemistry, or relevant scientific field/equivalent technical field preferred.
At least 3 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.
Ability to maintain written records of work performed in paper-based and computerized quality systems.
Ability to work independently on routine tasks and require some supervision on complex issues.
Ability to be organized and capable of working in a team environment with a positive demeanor.
A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.
Working knowledge of cGMP regulations and FDA/EU guidance related to biologics and cell banking.
Preferred Experience in Quality or Manufacturing for Large Molecule Manufacturing.
Working knowledge of Phase Appropriate GMP practices.
Experience with document reviews and regulatory inspection processes is preferred.
Ability to prioritize daily business needs while being flexible and adaptable to frequently shifting priorities.

Benefits

Comp & perks

medical, dental, vision, life insurance
short- and long-term disability
business accident insurance
group legal insurance
pension plan (401(k))
long-term incentive program
up to 120 hours vacation per calendar year
up to 40 hours sick time per calendar year
Holiday pay including up to 13 days floating holidays per calendar year
up to 40 hours work, personal and family time per calendar year