Johnson & Johnson Careers
Quality Associate II – Shop Floor (Third Shift)
Requisition ID: 9346180418
Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Associate II – Shop Floor (Third Shift). This position will be based in Lancaster, PA and is on 3rd shift (Sunday through Friday, 10:00pm - 6:00am.)
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.
In this role, you will manage quarantined materials and oversee label room, including verifying labeling issued to and returned from Operations. Perform periodic cGMP walk-through audits, process inspections, and electronic controlling system transactions.
Responsibilities include but are not limited to:
- Provides On-Line Quality Unit support including: real-time batch record and logbook review, component verification, line clearance, and preventive maintenance (as required).
- 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.
- Inspects Manufacturing and Packaging to ensure cGMP compliance.
- Performs compliance review of completed batch record.
- Reviews and releases components for packaging.
- Supports efforts for tactical compliance improvements.
- Supports Quality Notification investigation completions including: performing scope evaluation, performing draft reviews, and taking ownership of Preventive Actions.
- Reviews and comments on GMP documentation, including Standard Operating Procedures (SOPs), Master Batch Records (MBRs), Packaging Line Trials data review, events, etc.
- Ensures appropriate shift (including weekend) coverage.
- Leads inventory adjustments by reviewing Inventory Adjustment reports and notifying Quality when prescribed tolerances are exceeded during cycle counts.
- Performs weekly Inventory Adjustments audit.
- Verifies critical process parameters meet required specifications.
- 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.
- Knowledge cGMP regulations 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.
- Ability to work 3rd shift (Sunday through Friday, 10:00pm - 6:00 am.) is required.
J & J Consumer Inc. (6101)