What are the responsibilities and job description for the EMPQ Lead position at ANSA Compliance?
We are looking for a highly skilled Environmental Monitoring Performance Qualification (EMPQ) Lead with extensive experience in microbiology, data analysis, and cleanroom procedures within a pharmaceutical facility. The individual for this position will be required to work onsite in a high paced team environment to perform EMPQ activities. The candidate is expected to multi-task, communicate effectively, and possess a strong work ethic. Compensation will be hourly based at a very competitive top rate.
Responsibilities
- Test for microbial contamination and particulates in the air, water and/or compressed gas lines
- Providing documented verification of the cleanroom design, HVAC system, cleaning and disinfection program, personnel and material transfer flow, etc.
- Demonstrate contamination being controlled by monitoring the appropriate locations at the right frequency
- Perform Microbial Identifications
- Review and trend EM results
- Candidate must have qualification experience and/or knowledge of the following equipment: Total Air Particle Counters, Viable Air Samplers, Compressed Gas Total Air Particle Counters, High Pressure Diffusers, Compressed Gas Viable Samplers, Thermo-Hygrometers or Psychrometer, Drager Aerosol Samplers, Differential Pressure Manometers
- Translate system requirement specifications into executable validation protocols.
- Write reports summarizing EMPQ activities.
- Attend update meetings and provide status updates of current projects.
- Work with cross functional teams, system owners and stakeholders to review and approve documentation.
- EMPQ Risk Assessment, Baseline Study, Disinfectant Efficiency Study, Maximum Occupancy Study, Cleanroom Recovery Test, Smoke Study.Draft Environmental
· Final Summary Report which should include EM Results, Microbial ID, diagram of cleanroom and airflow direction between rooms, HEPA Filter Certifications and excursion summary.
- Track status of all deliverables and provide management updates. Meet required quality system and project timelines.
Knowledge
- Knowledge and understanding of ISO 14644-1:2015 and EU GMP Annex 1
- Knowledge and understanding of GMP guidelines
- Working knowledge of Microsoft Office Applications.
- Strong understanding of good manufacturing practices and/or good laboratory practices.
- Working Knowledge of 21 CFR Part 11 compliance in a GMP/GLP regulated industry, Data Integrity, GDP and adherence to ALCOA principles.
Requirements
- Understanding and practice of aseptic techniques
- Need to be self-motivated and capable of working in a fast-paced environment.
- Candidates must be dependable, reliable, and professional.
- Must be able to demonstrate leadership in a dynamic organization.
- Work with communication and project management skills to assist with project completion.
- Must demonstrate honesty and integrity.
- Comply with the company code of conduct and policies and regulatory standards.
- Work collaboratively with other colleagues and functions within the Client network
Job Types: Full-time, Contract
Pay: $75.00 - $105.00 per hour
Schedule:
- Monday to Friday
People with a criminal record are encouraged to apply
Experience:
- CSV: 1 year (Preferred)
Willingness to travel:
- 25% (Preferred)
Work Location: In person
Salary : $75 - $105