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Quality Associate II – Batch Record Review (Second Shift)
Requisition ID: 1091170922
Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Associate II – Batch Record Review (Second Shift),based inLancaster, PA.
Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.
- Ensures Quality System compliance as established in 21 Code of Federal Regulations (CFR) 210 and 211 Current Good Manufacturing Practices (CGMP) regarding quality methods and manufacturing and packaging processes and procedures.
- Conducts batch record review of completed batch record and performs final disposition of finished goods, packaging, and bulk transfer compiled records.
- Provides daily compliance leadership. Supports Quality Unit by providing training/mentoring, participating in Non-Conformance (NC) investigations, and owning appropriate Action Items (AIs).
- Reviews completed batch records for accuracy and completeness, assuring conformance to established standards.
- Dispositions external bulk and finished goods including Release to Trade.
- Delivers CGMP training.
- Supports efforts for tactical compliance improvements.
- Trains new Release Specialists.
- Supports NC investigation completions.
- Takes ownership of appropriate Action Items.
- Ensures quality and compliance by adhering to procedures and remaining current in all required CGMP training. Promptly identifies, reports, and seeks corrections for workplace deviations. Embraces culture of employee involvement and commitment to doing the job right the first time.
- Completes all assigned, required training before associated task execution.
- Supports other Quality Unit areas as necessary.
- Provides support during validation activities and special projects.
- Generates and evaluates change controls. Participates in change control and process improvement meetings.
- Strives to achieve daily quality outcomes for entire process from materials receipt through finished product shipment to the distribution centers.
- Partners with team to investigate and resolve process, technical, and quality related issues.
- Partners with Process Management to support process improvement and provide ongoing support to meet metric goals.
- Identifies compliance gaps and provides proposed resolutions.
- Provides peer performance feedback.
- A minimum of a Bachelor’s Degree is required. A technical degree is preferred.
- A minimum of 3 years of relevant CGMP pharmaceutical industry (Quality Unit and/or Manufacturing) experience required.
- Well-versed in latest Quality Assurance techniques is required.
- Knowledge and skills in validation processes and statistical process control, detection, correction and error prevention, process system challenges, sampling, audits, root cause analysis, and risk management is preferred.
- Basic computer knowledge is required; i.e. Microsoft Office (Excel, Outlook, and Word).
- SAP (Systems, Applications and Products in Data Processing) and EDM (Electronic Document Management System) proficiency is preferred.
This position will be based in Lancaster, PA and is on second shift (Monday through Friday, 4:00 p.m. to midnight)
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J & J Consumer Inc. (6101)