Qualification Specialist

Join our team at Bio Spectra, Inc., where we lead the way in delivering high-purity ingredients to the top 25 pharmaceutical companies globally. We are dedicated to maintaining the highest standards of excellence in the industry.

Bio Spectra, Inc. is a privately held, family-oriented organization and a U.S. based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. Bio Spectra, Inc. currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA and Scarborough, Canada.

Job Summary:

This position is responsible for ensuring that equipment, systems, and processes are qualified and validated in accordance with regulatory requirements and Bio Spectra's standards. This includes developing, executing, and reporting on equipment, instrumentation, and control system qualifications and re-qualifications

Essential Job Duties & Responsibilities:

• Create Qualification Protocols (IQ, OQ, PQ) for equipment, systems, and processes.
• Research & upload all support documentation into Bio Spectra's document management system as required.
• Complete Risk Assessments for all qualifications by utilizing Equipment and Process FMEAs (Failure mode and effects analysis).
• Document the execution of Qualifications and monitors the execution of qualification protocols to ensure successful completion of documentation and compliance with established procedures.
• Ensure the execution of qualification protocols are completed in a timely manner and within Manufacturing's time frames.
• Train personnel executing qualification protocols to understand instructions, accurate documentation practices and ensure compliance to established procedures. Create standard operating procedures for new or current equipment as necessary.
• Develop and execute temperature and humidity mapping studies within controlled storage areas and report on the execution.
• Evaluate the impact of any process and/or equipment changes to determine if qualifications and/or re-qualification of process equipment or process measuring tools is required.
• Work closely with multiple divisions to coordinate qualification efforts and resolve any potential issues through Bio Spectra's change control program or CAPA program
• Review and approve external manufacturer qualification documentation to ensure it aligns with Bio Spectra standards, and execute potential factory acceptance testing (FAT) or site acceptance testing (SAT)
• Assist in preparing for internal and external audits, ensuring all qualification documentation is readily available and in compliance
• Maintain an accurate database of completed equipment and system qualifications, and equipment qualification status to ensure continued process verification and monitoring of all current and pending qualified systems.
• Apply the appropriate qualification status in key areas to ensure the qualification status of equipment or systems in communicated to key personnel.
• Provide timelines for the qualification of equipment, processes or systems.
• Perform re-qualification of manufacturing equipment and systems in accordance with the current Equipment Qualification Master Plan and associated guidance documents to demonstrate that the equipment performs as intended throughout specified operating and performance ranges.
• Ensure all critical measuring tools are calibrated as required before the execution of a qualification protocol and files the associated documentation as needed.
• Identify and implement process improvements to enhance efficiency and effectiveness of the qualification process.

Qualifications:

• Education/
  
  Certifications:
  • Bachelor's degree in Science, Engineering or other related discipline, or commensurate experience in chemical, or pharmaceutical manufacturing, ideally with a cGMP manufacturer.
• Experience:
  • Minimum of one year of equipment qualifications experience at GMP manufacturer.
  • Advanced knowledge of cGMP requirements and practices and experience in an FDA registered facility.
  • Effective working knowledge of performing and understanding qualifications for instrumentation and control systems equipment.
• Special Skills &
  
  Competencies:
  • Must have accomplished analytical, oral communication and technical writing abilities and be able to read, understand and communicate in English.
  • Must be able to understand, analyze and interpret the Bio Spectra quality system and related documents.
  • Must be able to logically assess situations, manage multiple complex activities, and make competent, timely decisions amidst changing priorities.
  • Must have advanced knowledge and capability to understand mechanical systems, processes and equipment.
  • Ideally, will have advanced knowledge of instrumentation and control systems equipment.
  • Ability to work at an advanced level with Microsoft Word, Excel, and other applicable software systems as necessary.