J&J Family of Companies Quality Associate II – Shop Floor (Second Shift) in Lancaster, Pennsylvania

Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Associate II – Shop Floor (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.

Position Summary:

  • 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.

  • Reviews batch records and logbooks for cGMP compliance.

  • Performs Quality Assurance (QA) major cleaning clearance verification for Manufacturing and Packaging; manages quarantined materials; and oversees label room, including verifying labeling issued to and returned from Operations.

  • Performs periodic CGMP walk-through audits, process inspections, and electronic controlling system transactions.

  • Provides daily compliance support including real-time compliance consulting, issue resolution, and timely metrics achievement.

Responsibilities:

  • Provides On-Line Quality Unit support including: real-time batch record and logbook review, component verification, line clearance, and preventive maintenance (as required).

  • Inspects Manufacturing and Packaging to ensure CGMP compliance.

  • Performs compliance review of completed batch record.

  • Reviews and releases components and internal bulk for packaging.

  • Manages quarantined material inventory.

  • Delivers CGMP training.

  • 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.

  • Oversees inventory adjustments by reviewing Inventory Adjustment reports and notifying Quality when prescribed tolerances are exceeded during cycle counts.

  • Performs weekly Inventory Adjustments audit.

  • Oversees label room and verifies all labeling issued to and returned from Operations.

  • Verifies critical process parameters meet required specifications.

  • Generates defined metrics.

Qualifications

  • 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, 2:00 p.m. to 10:00 p.m.)

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.

Primary Location

United States-Pennsylvania-Lancaster

Organization

J & J Consumer Inc. (6101)

Job Function

Quality Control

Requisition ID

0995170922