Specialist 3 - Quality (contract)

Johnson & Johnson Family of Companies

Title: ICMS Specialist

Location: Lititz, PA

Duration: 1 year

Benefits on offer for this contract position: Health Insurance, Life insurance, 401K and Voluntary Benefits

Please note that this is a contract role providing services to the Johnson & Johnson Family of Companies through external staffing partners of Kelly OCG. If you are selected for this role, you will be employed by a contract staffing supplier and will not be a member of the Johnson & Johnson Family of Companies.

Candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families, and the communities in which we live and work.

Summary:

Under moderate supervision performs calibration and preventative maintenance on lab equipment and performs IQ/OQ on equipment. Adheres to Company policies, governmental and regulatory requirements and maintains adequate lab supplies.

Responsibilities:

• Support the purchase, install and equipment qualification of new laboratory equipment (Microbiology and Analytical Labs, QC Inspection).
• Develop configuration of system to be validated.
• Write validation test scripts and protocols.
• Execute validation protocols.
• Serve as a local system admin for computerized lab systems.
• Partners with Network IT Support for computer system validation activities.
• Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or perform maintenance or calibration activities.
• Lock Out Tag Out for lab equipment and equipment operating/calibration/preventative maintenance instructions meeting procdural standards.
• Author SOPs and Job Aides associated with laboratory equipment or related processes.
• Perform data entry for PM and CAL tasks performed by laboratory employees. Initiate change request work order.
• Provide consistent support for all laboratory instruments to ensure acceptable levels for performance, reliability, user satisfaction and integration with other systems.
• Operate within the confines of departmental SOPs and regulatory guidance. Additional Responsibilities:
• Communicates potential problems and issues to the Team Leader in a timely manner.
• Demonstrates competent computer use (entry/retrieval).
• Adheres to regulatory, company and departmental requirements.
• Ensure quality and compliance in all my actions by: All employees
• Attend GMP training on the schedule designated for my role and as appropriate for my role.
• Adhere to strict compliance with procedures applicable to my role.
• Exercise the highest level of integrity in the tasks that I perform.
• In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
• Embrace a behavior of employee involvement and commitment to doing the job right the first time.

Qualifications:

• B.S. Degree in Analytical Chemistry, Engineering or related sciences with at least 3 years of industry experience.
• Experience working within a GLP or GMP laboratory.
• Experience maintaining laboratory equipment such as particle size analyzers, X-ray fluorescence Detectors, Density Meters, Refractometers, or Halls Thickness Gauges.
• Deep expertise and experience handling computer system validations of laboratory systems.
• Computer skills with utilization of SDMS, Compliance Builder, and Empower. Experience with Maximo, SAP and LIMS preferred.
• Experience maintaining laboratory equipment (i.e., IC, GC, UPLC) or other specialized computerized systems.
• Capable of working independently under moderate supervision.
• Possesses good verbal and written communication skills and comfortable interacting with a variety of on-site and off-site collaborators.