Quality Control Metrologist

Role Summary

In this individual contributor role, the Metrologist is responsible for a variety of tasks related to calibrations of equipment, managing, and overlooking equipment change requests in a timely manner. Contacts vendors, when needed, and coordinates their activities.

Location: Millburn, NJ

Responsibilities

• Responsible for effective and efficient calibration to ensure compliance with quality standards and applicable CGMP regulations.
• Facilitates instrumentation calibration/qualification with external vendors, internal and/or external resources and local system owners.
• Supports the preparation of equipment binders containing technical & qualification lifecycle documents & required vendor documents, IQ/OQ/PQ Protocols, and Summary Reports for qualification of QC equipment.
• Ensure compliance with cGMP, regulatory regulations, and global/local policy for equipment.
• Develop / review appropriate SOPs and corresponding Forms.
• Responsible for performing all assigned activities within budget and schedule constraints.
• Ensure communication flows within the team and with all individuals involved in the process (e.g. Make- Test- Release team).
• As subject matter expert provide support during audit and inspection.

Qualifications

• Bachelor's degree in science or related field with 3+ years of experience in pharmaceutical industry or High School Diploma with 7 years of experience in pharmaceutical industry
• 3+ years of pharmaceutical industry experience required.
• Minimum of 2 years of laboratory instrument calibration, preventative maintenance experience, or applicable experience in a related area
• Working knowledge of aseptic manufacturing, cGMPs, GLPs and applicable compendial and regulatory guidelines (e.g. FDA, EP, JP)
• Experience with LIMS and BMRAM preferred
• Strong written and verbal communication skills
• Detail-oriented with expertise in problem solving and solid decision-making abilities
• Strong interpersonal skills