Product Quality Specialist

Johnson & Johnson

Product Quality Specialist overseeing pharmaceutical stability activities for Johnson & Johnson’s Innovative Medicine portfolio. Authoring protocols, managing lifecycle activities, and supporting audits, filings, and quality systems.

Posted 8/5/2026full-timeHorsham • New Jersey, Pennsylvania • 🇺🇸 United StatesMid-LevelSenior💰 $79,000 - $127,650 per yearWebsite

Core Competencies

Role fit

Core Competencies

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

Demonstrates expertise in API and drug product stability management, including protocol authoring and regulatory compliance. Proficient in quality processes such as change control and risk management, with strong communication and relationship-building skills.

Highest-signal resume keywords

API Stability ManagementRegulatory ComplianceQuality ProcessesPharmaceutical Industry ExperienceCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Stability Sample ManagementStability Protocol AuthoringChange ControlCAPARisk ManagementPharmaceutical ProcessesProduct Quality AssuranceProduct DevelopmentGMP RegulationsTemperature Excursion Management

Soft Skills

Team CollaborationRelationship BuildingIndependent WorkWritten CommunicationOral Communication

Industry Keywords

Pharmaceutical IndustryBiotechnologyMedical Device IndustryGlobal SOPsStability Lifecycle ActivitiesStability NotificationsContinuous ImprovementStability CoEAuditsRegulatory Filings

About the role

Key responsibilities & impact

Serve as stability point of contact for assigned API and drug product families
Oversee stability sample management
Author and oversee stability protocols and reports in accordance with global SOPs, including sampling strategy
Support audits and regulatory filings related to stability questions
Manage stability lifecycle activities
Support PQI/PQO and business partners with stability-related questions
Support temperature excursions, change controls, stability notifications, and escalations
Maintain stability statements for assigned products
Partner with Stability Labs to address questions promptly
Support Stability CoE departmental goals and continuous improvement
Contribute input during staff meetings to improve stability processes

Requirements

What you’ll need

Bachelor’s degree required, majoring in Pharmacy, Chemistry, Biology, Biochemistry, Engineering, or a similar technical/scientific discipline
Minimum 6 years of relevant experience required
Minimum 4 years of experience in the pharmaceutical, biotechnology, or medical device industry required
Postgraduate experience and/or education counts toward years of industry experience
Experience in API and drug product stability and business implications of stability decisions desired
Understanding of quality processes and systems, including change control, event handling, CAPA, and risk management required
Insight into pharmaceutical and/or chemical processes, product quality assurance/control, and product development and manufacturing is a plus
Ability to work independently and in a team environment
Relationship building as part of a team required
Strong written and oral communication skills with various organizational levels
Understanding of global regulatory requirements and guidelines applicable to pharmaceuticals, with ability to apply GMP regulations
Flexibility to accommodate US, EMEA, and AP work schedules when vital
Willingness to travel 5–10% domestically and internationally

Benefits

Comp & perks

Retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (48 hours in Colorado; 56 hours in Washington)
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time – up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Inclusive interview process and disability accommodations