Environmental Monitoring Specialist QA 29995258
Environmental Monitoring Specialist (Biotechnology Industry)
Location: Puerto Rico (Open to local candidates)
Position: 1
Duration: Approximately 1 year
Work Mode: Hybrid/Remote (Onsite work preferred)
Summary
Our client is seeking an Environmental Monitoring Specialist to support its Quality Assurance (QA) program with minimal supervision. The selected candidate will be responsible for ensuring compliance with Good Manufacturing Practices (cGMPs) and regulatory standards related to environmental monitoring (EM) and critical utilities (CU) in a biotechnology manufacturing setting.
Educational and Experience Requirements
Candidates must meet one of the following qualifications:
- Doctorate degree OR
- Master’s degree with 3 years of directly related experience OR
- Bachelor’s degree with 5 years of directly related experience OR
- Associate’s degree with 10 years of directly related experience OR
- High school diploma/GED with 12 years of directly related experience
Key Responsibilities
- Support the Environmental Monitoring Process for GMP facilities.
- Generate trend reports for Environmental Monitoring and Critical Utilities.
- Participate in or lead Risk Assessments to evaluate sampling sites for GMP areas.
- Assess change control records, deviations, and audits from an Environmental Control perspective.
- Represent QA in forums such as:
- Environmental Control Network
- Aseptic Council
- Contamination Control Network
- Attend Quality System forums and Management Review meetings to present environmental and critical utilities data, making recommendations based on data evaluation.
- Ensure compliance of facilities, equipment, materials, and processes with cGMPs and regulatory standards.
- Support Continuous Improvement initiatives, programs, and projects related to environmental control.
- Collaborate cross-functionally to align Quality Management System (QMS) processes with established procedures.
- Alert senior management of risks related to quality, compliance, supply, and safety.
- Provide support for internal/external audits and regulatory inspections.
Preferred Qualifications
Educational Background
- Degree in Life Sciences (Biology, Microbiology, or related field)
Technical Knowledge & Skills
- Environmental Monitoring (EM) and Microbial Identification (Micro ID)
- Critical Utilities (CU) monitoring
- Sampling techniques and equipment for environmental monitoring
- Data trending and statistical analysis
- Microbiological testing methods for cleanrooms and controlled environments
- Aseptic behavior in manufacturing to prevent contamination
- Facility cleaning and disinfection processes
- Regulatory knowledge of Annex 1, FDA Guidance, ISO-14644-1, and USP
- Proficiency in software tools such as:
- Microsoft Office Suite (Word, PowerPoint, Excel)
- Smartsheets, Spotfire, LIMS, Maximo, Veeva
- AI tools for data analytics and trend evaluation
- Ability to interpret and report environmental/CU monitoring data
- Fully bilingual in English and Spanish (written and oral)
Key Functions
- Review and approve Manufacturing Procedures (MPs).
- Approve process validation protocols and reports.
- Provide QA oversight for incident triage teams.
- Approve Environmental Characterization Reports.
- Authorize sanitary utility system releases.
- Approve planned incidents and change controls.
- Represent QA in New Product Introduction (NPI) teams.
- Lead investigations and site audits.
- Own and manage site quality program procedures.
- Act as a designee for the QA Manager on local Change Control Review Boards (CCRBs).
- Review and approve Risk Assessments.
- Support Automation, Facilities, and Environmental Programs.
- Review and approve Work Orders and EMS/BMS alarms.
- Approve Non-Conformance (NC) investigations and CAPA records.
- Provide lot disposition and authorization for shipment.
Competencies & Skills
- Project management expertise with the ability to lead cross-functional teams.
- Strong organizational skills to manage multiple priorities effectively.
- Ability to influence, negotiate, and collaborate across different teams.
- In-depth knowledge of QA, QAL, validation, and process development.
- Experience interacting with regulatory agencies.
- Strong proficiency in data trending and evaluation.
- Demonstrated ability to assess compliance issues and propose solutions.
- Exceptional written and verbal communication skills in both English and Spanish.
- Ability to work independently while effectively engaging with stakeholders at all levels.
This role offers an opportunity to contribute to a dynamic team in a biotechnology manufacturing environment, ensuring compliance with environmental and quality standards while driving continuous improvement initiatives. Apply inside the job description with an upated resume.