Quality Assurance Analyst III

Job Description

Job Description

Mason-Grey is hiring a Quality Assurance Analyst to join the M-G Team with experience in eLIMS and is an expert in data setups in the eLIMS system to support lab processes.

POSITION: Quality Assurance Analyst III

LOCATION: Titusville NJ OR Horsham PA OR Wilson NC*

*Hybrid – 3 days Onsite/balance remotely

COMPENSATION: The hourly rate is a maximum range of $32.00 to $35.00. Annualized (50 weeks / 40 hours per week, 2000 hours) range of $64,000 to $70,000 based on actual hours worked. OT is payable at 1.5X over 40 hours per week.

JOB DESCRIPTION/EXPERIENCE:

• This position works within the eLIMS CoE and is an expert in data setups in the eLIMS system to support lab processes including paperless, product release and CofA generations. Additionally, this position will support an implementation of the LIMS LabVantage (eLIMS) system at a new plant based in North Carolina as part of Johnson and Johnson, Innovative Medicine. This position independently maintains and reviews high quality data setups, integrates instruments and applications and translates specifications within the eLIMS system using current business processes. This position reviews and tests system updates, creates and manages any system related documents, and identifies and drives process improvements. This position is able to interact with IT and speaks business language to customers.
• This position takes ownership by completing any incoming requests in a timely manner. In order to maintain high quality data. This position is expected to fully understand the sites master data requirements and lab processes to ensure all configurations are accurate and complete.
• This position is responsible and able to lead projects within QC Operations, e.g. implementation of paperless processes, harmonization / standardization of processes. Candidate to work with multiple stakeholders to provide input and ensure end to end set up of eLIMS master data to support implementation.
• Maintains system related documentation (procedures, events, etc) with the appropriate applications (TruVault, COMET, Confluence, q-Test or any other designed system;
  
  

Qualifications:

• A minimum bachelor's degree or equivalent education is preferred. A minimum of 4 – 6 years of working experience in a regulated medical industry (Pharmaceutical, Medical Devices, or Diagnostics) with knowledge and experience with LIMS and Quality Systems is required. Extensive other experience with analytical testing, quality control or IT is preferred.

• Ability to manage multiple issues, organize activities, prioritize, and escalate to management when appropriate. Broad knowledge and experience with cGMPs, applicable regulations (e.g., FDA, ICH Q8, 9, 10), and risk management.
• Demonstrated strong written and verbal communication skills (Basic in English – B2) and the ability to develop and provide training to colleagues and partners.
• Demonstrates flexibility in adapting to urgent needs. Ability to interact with local lab leaders on master data related issues as needed and maintain a strong relationship with local laboratories.
• Maintain a clear line of communication with the eLIMS CoE lead. High level commitment to meeting customer expectations as determined by the eLIMS CoE lead.
• Familiarity with building a system from the bottom to the top
• Experience with automation to help with automation of eLIMS setup
• Master Data experience (back-end experience), building the system experience not user experience required
• Experience with TruVault, COMET, Confluence
• Experience with Analytical Testing required
• Experience with laboratory systems

All candidates shall be legally authorized to work in the US and are subject to background screening, drug testing and verification of legal status in the United States using eVerify.

At Mason-Grey Corporation, we deliver smart engineering solutions to American process industries that keep the world moving—energy, metals, plastics, biotech, pharmaceuticals, and more. From coast to coast, we support Fortune 500 giants and mid-sized innovators alike, tackling complex process projects. Our team lives and works nationwide from Massachusetts to California. Proudly headquartered in Atlanta, Georgia, Mason-Grey is the trusted partner behind some of America’s most critical industrial operations.

Company Description

At Mason-Grey Corporation, we deliver smart engineering solutions to American process industries that keep the world moving—energy, metals, plastics, biotech, pharmaceuticals, and more. From coast to coast, we support Fortune 500 giants and mid-sized innovators alike, tackling complex process projects. Our team lives and works nationwide from Massachusetts to California. Proudly headquartered in Atlanta, Georgia, Mason-Grey is the trusted partner behind some of America’s most critical industrial operations.