Description

Janssen Biotech, Inc. a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Operations Associate II in Malvern, PA !

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.

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 Quality Assurance Operations ( QA) Associate II is responsible for providing Quality Assurance and Quality Oversight services to designated manufacturing sites. This role ensures compliance to the validation life cycle. They will review a wide variety of validation documents, including any or all the following: mechanical, cleaning, automation, calibration, QC methods and instruments, process systems/equipment (IQ/OQ/PQ, PVs, VA, TS, TR, TD), SOPs, Logbooks, Validation Maintenance Reports, Commissioning Documents, and/or Design Documents. The associate ensures compliance with cGMPs and is responsible for performing regular scheduled oversight within manufacturing, warehouse, and QC labs to ensure inspection readiness at all times.

Key Responsibilities:

• Review and approve system discrepancies, exceptional conditions and non-conformances that may occur during execution of initial validations, re-qualifications, and re-validations and execute in the large molecule platform.
• 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.
• Independently perform QA Compliance Validation activities, identify issues and implement resolutions, assess data, and independently prepare and review documentation.
• 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
• Direct QA and validation services experience within a GxP regulated manufacturing environment
• Proficient technical writing skills, including strong organizational, communication, and project management skills
• Biotechnology or pharmaceutical industry experience
• GMP Manufacturing equipment and/or automation validation experience

Preferred:

• 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:

• Requires 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.careers.jnj.com .