QUALITY ASSURANCE ASSOCIATE II

Janssen Pharmaceuticals, Inc a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance (QA) Associate II at the Malvern, PA campus! At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
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Are you interested in joining a team that is introducing new products to manufacturing and improving existing processes to help improve patient and customer care? Apply today to this exciting opportunity! In this role, you will be providing quality oversight for daily activities related to commercial supply chain operations supporting production of commercial and clinical drug substance in the biotherapeutics product portfolio.
You will 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.
The QA Associate II is responsible for providing Quality Assurance and Quality Oversight services to designated manufacturing sites.
This role ensures the manufacturing site maintain a state of inspection readiness through internal audits and by assuring compliance with regulatory and Johnson & Johnson requirements.
The associate ensures compliance with cGMPs and is responsible for performing regular scheduled oversight within manufacturing, and warehouse areas to ensure inspection readiness at all times.
Key Responsibilities.
Provides Quality review and guidance associated with investigations, change controls, protocols, reports, area releases, project planning and site procedures.
Provide quality input on a variety of compliance related issues and attend meetings as a quality representative.
Act as Quality representative to provide on the floor and on-call quality support in Manufacturing Operation and escalate issues to quality management for consultation.
Partner with QA Document Control, QC, Manufacturing, Execution Systems, Plant Logistics, Validation/Compliance, and Regulatory Affairs to ensure documentation/process changes align with regulatory filings and maintain validated process.
Increase the compliance profile by identifying gaps within processes and procedures.
Provide support on Local and Global Change controls-related items such as providing input on the proposed changes impact assessments and implementation plans.
Revise and acquire approval for departmental documents and coordinate document approvals against timelines.
Support internal and external audits, inspections, FDA pre-inspection readiness, certifications, tracking, and trending activities.
Support the maintenance program by reviewing, approving, and documenting within SAP, Work Orders, PM/Calibration Extensions, and PM/Calibration Change Requests.
Work independently on routine tasks and will have support to resolve some complex technical issues.
Ensure all non-conformances are fully investigated and effective corrective/preventive actions (CAPA) are implemented in a timely manner.
Review and approve controlled documents including standard operating procedures, work instructions, validation protocols and reports, and technical studies.
Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans.
Review production documentation and provide guidance to resolve quality related manufacturing issues and/or documentation discrepancies.
Support quality activities related to Batch Record Review, Intermediates and Finished Product Releases.
Author and revise quality departmental documents.
Supports site inspections and inspection readiness activities.
Ensure the site is audit ready.
Support data integrity efforts.
Qualifications Education.
Bachelor’s Degree required; focused degree preferred in Engineering, Science, or equivalent technical subject area.
Skills and Experience.
Required.
Minimum 2 years of relevant work experience Proficient technical writing skills, including strong organizational, communication, and project management skills Preferred.
Biotechnology or pharmaceutical industry experience GMP Manufacturing equipment and/or automation validation experience Manufacturing execution software experience Quality investigations experience Experience in regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.
Knowledge of cGMP regulations and FDA/EU guidance.
A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills Other.
This role may require up to 10% of domestic travel.
This is an onsite role.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
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