HireDiversity

Fort Washington, PA, US

Quality Operations Supervisor-8862130117

Description

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc, a member of the Johnson & Johnson Family of Companies, is currently recruiting for a Quality Operations Supervisor based in Ft. Washington, PA.

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, IMODIUM® A-D anti-diarrheal, MOTRIN® IB, and SUDAFED® nasal decongestants.

The Quality Operations Supervisor will be accountable for providing leadership and guidance on compliance and Good Manufacturing Practice (GMP) that pertains to the packaging and manufacturing operations, to meet company standards and Regulatory Health Authority requirements. They also will support multiple functions, provide sound and timely decision making by utilizing statistical and problem solving tools. This individual will identify significant compliance and housekeeping issues and prioritize for action. They also will lead, promote, and implement improvement opportunities and problem solutions as well as interact with internal and external entities to harmonize practices and standards across the company.

The Quality Operations Supervisor will provide leadership support to all QA Shop Floor activities including communication of quality events to management. They will perform or support activities related to In-Process Testing, AQL's, and/or Investigational Protocol Execution. This individual will provides support to Investigations and/or CAPA and evaluate non-conformance investigations provided by the operations assuring that all appropriate investigation steps were conducted and that appropriate corrective actions were devised where applicable. They will also perform or support activities related Line or Manufacturing Area Clearance Verifications and may perform or support activities related to Master Batch Record creation/approval and Batch Record Issuance. In addition they may perform or support activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Approval & Disposition.

Responsibility of the Quality Operations Supervisor will include performing transactions in the following electronic systems: SAP, LIMS, and MES. This individual will participate in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP's) and Work Instructions (WI's) and will provides support to Consumer Complaint investigations, as needed. The Quality Operations Supervisor will participates and provide Quality Assurance support to Change Controls, Equipment Qualifications such as Packaging Line Trials, and Validation activities. This individual will also provide support to Plant Maintenance for calibration system verification in SAP, as needed and provide QA support to various project teams, as needed. This individual will provide support to Regulatory Inspections and Internal Audits as well as actively support site metrics, compliance improvement and training initiatives. They will lead or participate on FMEAs, Green Belt or Black Belt projects. This individual will participate in core Teams for both Manufacturing and Packaging operations to identify daily challenges on compliance and housekeeping opportunities that affect the quality of the product. They also will engage vendors in investigations that pertain to the quality of finishing supplies or raw materials and assure that corrective actions are devised where applicable.

All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.

Qualifications


A minimum of a Bachelor's Degree is required. A focused degree in Science or a closely related technical discipline is preferred. A minimum of 3 years of relevant Quality experience within the OTC and/or Pharmaceutical industry is required. Active cGMP interpretation and application experience is required. Process and systems experience, specifically SOPs, MBRs, Change Controls, is required. Non-Conformance Investigation and CAPA experience is required.

Previous experience supervising others is preferred. Previous Project Management experience is preferred. Computer System experience with SAP and LIMS is preferred. Previous Validation Experience is preferred. Six sigma Process Excellence tools, training and/or certification is a plus. This candidate must have strong organizational, communication/interpersonal and facilitation skills (verbal, written and presentation). This candidate must have excellent problem solving skills and must demonstrate expertise in handling multiple priorities simultaneously.

This position will be based in Ft. Washington, PA and may require minimal travel.

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:North America-United States-Pennsylvania-Fort Washington
Organization: McNeil-PPC, Inc. (6101)
Relocation: Eligible
Yes - Within Country