QA Associate II

Johnson & Johnson

QA Associate II at Johnson & Johnson overseeing quality in GMP manufacturing areas. Collaborating with teams to support clinical product manufacturing and ensure compliance with quality standards.

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

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in GMP manufacturing oversight, quality compliance, and regulatory standards, with a strong focus on process improvement and effective communication across teams. Proficient in managing documentation and change control processes while ensuring adherence to cGMP regulations and FDA/EU guidance.

Highest-signal resume keywords

GMP Manufacturing OversightQuality ComplianceDocument ReviewRegulatory Inspection ProcessesProcess Improvement

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

GMP RegulationsQuality SystemsBatch Record ReviewControlled Document ApprovalRisk AssessmentChange ManagementNon-Conformance InvestigationPhase Appropriate GMP PracticesBiotechnology ManufacturingPharmaceutical Manufacturing

Soft Skills

Attention to DetailInterpersonal CommunicationOrganizational SkillsTeam CollaborationAdaptability

Industry Keywords

BiologicsCell BankingFDA GuidanceEU GuidanceRegulated Manufacturing

About the role

Key responsibilities & impact

Provide end to end quality oversight of GMP manufacturing areas.
Act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.
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.
Other duties may be assigned as necessary.

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.
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
consolidated retirement plan (pension)
savings plan (401(k))
long-term incentive program
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year