Metrology Specialist - Contractor

Job Title: Senior Metrologist (Contractor)

Job Classification: Exempt

Purpose of Position

The Senior Specialist in the ICVS department plays a crucial role in executing daytoday metrology duties to provide accurate and timely support to the analytical operations staff. This is a LeaveofAbsence contract for at least 2 months.

Responsibilities

• Perform routine and unscheduled maintenance calibration and qualification of assigned laboratory equipment. Collaborate with external vendors MIS Quality Assurance and analytical operations management to ensure timely qualification calibration and maintenance.
  
• Ensure installations and maintenance activities adhere to safety codes and standards (e.g. OSHA NEC NFPA 70 NFPA 70E).
  
• Ensure timely and accurate instrumentation calibration and validation services to minimize equipment downtime and impact on analytical operations.
  
• Generate review and approve ICVSrelated work orders maintenance calibration validation and GMP documentation for Standard Operating Procedures (SOPs).
  
• Troubleshoot laboratory equipment and systems addressing issues of increasing complexity requiring independent judgment.
  
• Maintain workspace cleanliness following the 5S method of organization.
  
• Adhere to safe work practices ensuring all duties are performed in a safe manner and promptly report unsafe conditions to the supervisor.
  
• Duties and responsibilities may be expanded as deemed necessary by management.
  

Qualifications Experience and Education

• Minimum of 6 years of industryrelated work experience; 8 years preferred.
  
• Bachelors degree or equivalent in an engineering or scientific discipline required. Engineering certification and/or advanced degree preferred.
  

Knowledge Skills and Abilities

• Advanced knowledge of cGMP FDA regulations and ICH guidelines in relation to contract laboratory operations.
  
• Proficiency in USP Pharm. Eur. and other compendial methods and procedures.
  
• Advanced understanding of operational and maintenance requirements for basic laboratory equipment (e.g. HPLC GC ICP TOC Karl Fischer) and temperaturecontrolled storage chambers.
  
• Expertise in electronic data and document management systems (e.g. ProCal LIMS MasterControl Chromeleon).
  
• Strong interpersonal skills clear and concise oral and written communication and the ability to present information effectively to managers customers and employees.
  
• Effective organizational and time management skills including multitasking and prioritizing assignments as needed.
  
• Ability to work under pressure in a rapidly changing environment.
  
• Ability to work independently and collaboratively with colleagues both inter and intradepartmentally.