Lead Metrologist

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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Job Summary

The Lead Metrologist is considered a Subject Matter Expert in the Metrology field. They will be accountable for driving results in a fast-paced environment by performing calibration and diagnostics repair of Analytical instrumentation including HPLC, GC, Spectrophotometers and other complex equipment in pharmaceutical laboratory environments. Some travel will be required to support other Alcami sites. They will provide oversight into tasks being performed by other team members and provide guidance to ensure the success of the team.

In addition, the Lead Metrologist will develop/update processes & procedures to improve the quality and efficiency of the department. Maintaining calibration of metrology standards and completing and reviewing calibration documents. The ideal candidate will use computerized equipment and software to perform testing functions and produce graphs. The position requires strong leadership behaviors, as well as expertise in functional competencies.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Performs maintenance, testing, troubleshooting, calibration and repair on a variety of circuits, components, analytical equipment and instrumentation for pharmaceutical laboratory equipment.
• Specifies and requests purchase of components.
• Utilizes several database systems.
• Analyzes results and may develop test specifications and electrical schematics.
• Maintains all logs and required documentation.
• Prepares technical reports with recommendations for solutions to technical problems.
• Reads, writes and follows Standard Operating Procedures (SOP’s).
• Writes Out-Of-Tolerances (OOT’s) and Deviations.
• Trains other team members on complex systems.
• Develops/Updates training program to ensure compliance with current procedures.
• May stand in for Manager/Supervisor during client audits and authority inspections.
• Disassembles and reassembles instruments and equipment, using hand tools, and inspects instruments and equipment for defects.
• Modifies performance and operation of component parts and circuitry to specifications, using test equipment and precision instruments.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Qualifications

• Associate’s degree with 10 years related experience or equivalent.
• Bachelor’s degree with 8 years of experience.
• Technical field of studies is preferred.
• Previous work experience in a GMP facility required.

Knowledge, Skills, and Abilities

• Excellent documentation, critical thinking, analytical, problem solving, detail orientation, organization and time management skills required.
• Excellent understanding of circuits, components, analytical equipment and instrumentation for laboratories.
• Excellent mechanical skills.
• Excellent verbal and written communication skills.
• Excellent organizational skills.
• Project management experience a plus.
• Prior involvement in customer audits and authority inspections a plus.

Travel Expectations

• Up to 20% to clients is required.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 50 pounds and occasionally lift and/or move over 50 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.