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Quality Assurance Associate III - Investigations
Requisition ID: 3226180207
Johnson & Johnson Consumer Inc, a member of Johnson & Johnson's Family of Companies, is recruiting a QualityAssurance AssociateIII - Investigations to be located in Fort Washington, 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.
The Quality Assurance - Associate III - Investigations is accountable to provide support to the investigation process that pertains to the manufacturing and packaging operations in addition to guidance on compliance and Good Manufacturing Practice (GMP) to meet J&J standards and regulatory expectations.
In this role, you will support multiple functions' sound and timely decision-making by utilizing statistical and problem-solving tools through the investigation process, you will identify significant compliance and housekeeping issues and prioritize for action.
Responsibilities include but are not limited to:
- Lead and facilitate investigations and relative improvement projects and initiatives identified root cause analyses.
- Assure all compliance issues pertaining to manufacturing and packaging operations are properly investigated and that corrective actions are devised to prevent recurrence.
- Provide support for investigations pertaining to manufacturing and packaging deviations in a manner that their conclusions meet company and regulatory expectations.
- Evaluate non-conformance investigations provided by functional areas assuring that all appropriate investigation steps were conducted and that appropriate corrective actions were devised where applicable.
- Consult with the functional areas to align cGMP requirements, J&J and regulatory guidelines.
- Lead or participate on FMEAs, Green Belt or Black Belt projects.
- Maintain knowledge of regulatory environment, cGMPs, FDA policies and current industry trends.
- Participate in core Teams for Manufacturing and Packaging operations as applicable to identify daily challenges on compliance that affect the quality of the product.
- Perform and understand investigation trending in order to determine appropriate CAPA's in response to trends.
- Ensure investigation metrics and trends are available for presentation during regulatory inspections and inclusion in APRs.
- Assist in leading all manufacturing operation deviation investigations and CAPA implementations. Initiates manufacturing deviations, performs root cause analysis, conduct investigations to assess impact on products and process, recommends product disposition and recommends change controls and CAPA's as needed.
- Assist in the APR process to provide information as a contributor.
- Establish relationships with the QA Release group and Operations to determine/understand their needs and build trust/confidence in order to resolve investigations.
- Ensure site SOPs accurately reflect the investigation process and update as necessary.
- A minimum of a Bachelor’s degree is required. Advanced degree preferred.
- a minimum of 3 years’ experience in a pharmaceutical, OTC and/or biological manufacturing operation investigating manufacturing deviations, investigations and events either in a QA or manufacturing role is required.
- Working knowledge of pharmaceutical facilities, equipment, laboratories and systems is required.
- Experience with statistical analyses tools is required.
- Experience with LIMS, SAP-QM, and EtQ is preferred
- Demonstrated Lean I Six Sigma knowledge is preferred.
- Experience with Microsoft based Office applications is required.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
United States-Pennsylvania-Fort Washington
J & J Consumer Inc. (6101)