Equipment Calibration Specialist / Technical Documentation Specialist

Company Overview

A&Z Pharmaceutical Inc. is a pioneering leader in the development, manufacturing, and marketing of high-quality pharmaceutical products and nutritional supplements. With over 30 years of industry experience, the company operates globally with dedicated research laboratories and manufacturing facilities committed to advancing health and wellness worldwide.

Job Overview

A&Z Pharmaceutical Inc. is seeking a detail-oriented Equipment Calibration Specialist / Technical Documentation Specialist to support equipment calibration, qualification, maintenance tracking, and technical documentation within a regulated pharmaceutical manufacturing environment.

This position combines hands-on equipment calibration responsibilities with technical writing and documentation management. The successful candidate will help ensure that manufacturing and laboratory equipment is properly calibrated, qualified, maintained, and documented in accordance with established procedures, cGMP requirements, and applicable FDA regulations.

The ideal candidate will have an engineering degree, practical experience with equipment calibration and calibration records, and the ability to develop, review, and maintain technical documentation. This individual will work closely with Quality Assurance (QA), Technical Operations, and Maintenance to support equipment reliability, regulatory compliance, audits, and continuous improvement initiatives.

Key Responsibilities

Equipment Calibration and Maintenance

• Perform and/or coordinate equipment calibration activities in accordance with approved procedures, established schedules, and manufacturer specifications.
• Maintain an accurate equipment inventory, including equipment identification numbers, locations, specifications, calibration status, and maintenance history.
• Monitor calibration due dates and coordinate scheduled and overdue calibration activities with internal departments and external service providers, as applicable.
• Review calibration results and supporting documentation for completeness, accuracy, and compliance with established acceptance criteria.
• Identify and report out-of-tolerance results, overdue calibrations, equipment discrepancies, and other issues requiring investigation or corrective action.
• Maintain calibration logs, certificates, equipment history files, and supporting records.
• Support equipment troubleshooting and collaborate with Maintenance and Technical Operations to address equipment-related issues.
• Assist in evaluating the impact of calibration failures or equipment deviations on equipment suitability and documented processes.

Equipment Qualification and Validation

• Support the preparation, execution, and documentation of Installation, Operational, and Performance Qualification (IOPQ) protocols, as applicable.
• Assist with equipment qualification, requalification, verification, and validation activities.
• Prepare and maintain qualification protocols, test forms, reports, and related technical documentation.
• Document test results, discrepancies, deviations, and corrective actions accurately and promptly.
• Work with QA and Technical Operations to ensure qualification activities are completed in accordance with approved protocols and applicable requirements.
• Assist with reviewing qualification documentation and maintaining complete equipment qualification files.

Technical Writing and Documentation

• Draft, revise, review, and maintain Standard Operating Procedures (SOPs), work instructions, equipment procedures, validation protocols, and technical reports.
• Prepare and maintain master batch records and other manufacturing documentation, as assigned.
• Ensure technical documents accurately reflect equipment operation, calibration procedures, maintenance requirements, and approved processes.
• Review documents for accuracy, consistency, completeness, and compliance with cGMP and applicable FDA requirements.
• Update documentation to reflect equipment changes, revised procedures, process improvements, and corrective actions.
• Organize and maintain controlled documents and technical records to support internal and external audits.

Change Control and Deviation Documentation

• Assist in preparing and tracking change control requests related to equipment, calibration procedures, maintenance activities, and technical documentation.
• Collaborate with QA and relevant departments to evaluate documentation requirements associated with equipment or process changes.
• Support the documentation of deviations, investigations, corrective and preventive actions (CAPAs), and other quality-related activities, as assigned.
• Ensure applicable equipment records and controlled documents are updated following approved changes.
• Track outstanding documentation activities and communicate status updates to relevant stakeholders.

Equipment Records and Compliance

• Maintain organized, accurate, and readily accessible equipment files and calibration documentation.
• Assist with audit preparation by retrieving calibration records, qualification packages, maintenance logs, and related controlled documents.
• Monitor documentation, review dates and help ensure records remain current and compliant.
• Identify documentation gaps and recommend improvements to calibration tracking, recordkeeping, and document control processes.
• Work with QA to support compliance with company procedures, cGMP requirements, and applicable regulatory expectations.

Requirements and Qualifications

• Bachelor’s degree in Engineering required.
• Hands-on experience with equipment calibration and maintaining calibration records required.
• Ability to understand equipment specifications, calibration procedures, measurement results, and technical requirements.
• Experience with equipment qualification, validation, maintenance, or calibration documentation preferred.
• Familiarity with cGMP requirements and FDA-regulated manufacturing environments preferred.
• Technical writing experience, including SOPs, protocols, technical reports, or other controlled documentation, preferred.
• Strong attention to detail and the ability to identify documentation discrepancies and follow established procedures.
• Proficiency in Microsoft Word and Excel; experience with electronic document management systems is a plus.
• Strong organizational, analytical, written, and verbal communication skills.
• Ability to work collaboratively with QA, Maintenance, Technical Operations, and other departments.
• Ability to read and write English proficiently.

Candidates with an engineering degree and relevant hands-on calibration experience are encouraged to apply. Candidates with limited technical writing experience may be considered if they demonstrate strong technical skills and the ability to learn documentation requirements.

Job Type

Full-time

Benefits

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Pay: $50,000.00 - $65,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Experience:

• Equipment calibration and Validation: 1 year (Required)
• cGMP and FDA Manufacturing : 1 year (Required)
• Technical writing including SOPs, protocols, Tech reports: 1 year (Required)

Work Location: In person

Salary : $50,000 - $65,000