QC Laboratory Validation-Metrology Specialist

The Opportunity:

Avantor is looking for a QC Laboratory Validation-Metrology Specialist to join our Phillipsburg, NJ team!

What we’re looking for

• Education: Bachelor of Science degree, or equivalent experience in science, engineering, or technical field
• Experience: 2 years of related laboratory or instrument experience
• Collaboration Tool: Knowledge of office computer software such as Word and Excel
• Preferred Qualifications: 
  • Certified Calibration Technician (ASQ)
  • Knowledge of GMPs, USP, and other compendia
  • Able to operate a variety of lab equipment
  • Experience with automated data retrieval systems

How you will thrive and create an impact

Works independently under close supervision, qualify and validate equipment, instruments, and systems. Develop validation plans, protocols, and testing specifications. Analyze validation reports and make recommendations for changes and/or improvements. Assist in the selection of equipment and systems and negotiate competitive pricing. Work with regulatory agencies on inspections.

Determines, tracks, and improves the precision of the laboratory analysis process for specific, assigned products. Primary accountability is Platinum level customer product related metrology. Identifies inherent laboratory process variation to determine the overall net capability of measurement processes in quantitative terms for assigned products. Modifies or redesigns laboratory analysis process to improve capability, minimize error potential and variability. Develops calibration methods and techniques based on principles of measurement science, technical analysis of measurement problems, and accuracy and precision requirements. Is a resource to engineering, quality, and laboratory personnel in design, manufacture evaluation, and calibration of: measurement standards, human interface, instruments and test systems, to assist in the selection of appropriate instrumentation, employee training, and overall laboratory process environment and systems. Collaborates at an inter-facility level with metrologists to globally standardize the laboratory process for assigned products. A Quality Metrologist is accountable for reliable and accurate laboratory analytical process systems, to assure generated data meets all the requirements for the production and transfer of data related to assigned Platinum level customer products.

• Adhere to all plant safety rules and 100% completion of all required training; encourage and support site safety programs.
• Conduct Gage R&R studies, root cause investigations, to identify, quantify, and lead or assist in the correction of sources contributing to uncertainty of results.
• Leads and is accountable for laboratory analytical process profiling through use of P/T ratios and SPC/SQC applied to relevant people, processes, and equipment for assigned products.
• Proactively seeks and recommends data retrieval and reporting automation for improved laboratory process and supply chain.
• Collaboratively sets global analytical standard process of record with Metrologists and Quality Engineers for Platinum customer products.
• Accountable for all necessary QC test and measuring instrumentation calibration, documentation, operation and calibration SOPs, instrument repair & service coordination, specific to assigned products.
• Provide assistance and instruction to aid trainers and users in general operation, care, trouble-shooting, performing preventative maintenance, and making minor repairs to assigned equipment.
• Participate or lead in the transfer of instrument related methods into QC from R&T.
• Accountable for uploading of PCS data for assigned platinum level customer products.
• Participate in internal and external audits.
• Participate in OOS and OOC investigations.
• Other duties required to maintain cGMP and Micro-electronic quality system compliance within the QC lab.
• Other duties as assigned with or without accommodation.

KNOWLEDGE SKILLS AND ABILITIES

• Knowledge of calibration techniques and applications.
• Knowledge of measurement uncertainties and the ability to analyze data.
• Good written and oral communication skills, good presentation skills, and interpersonal skills.
• Good writing/documentation skills.

#LI-Onsite

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor i