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QC Environmental Monitoring Specialist
1 month ago
Beacon Hill Pharma is seeking a highly skilled QC Environmental Monitoring Associate to join our team. The successful candidate will be responsible for conducting environmental monitoring to support Manufacturing and Quality Control, including air, surface, personnel, and particulate testing within clean rooms.
Key Responsibilities:
- Conduct environmental monitoring to ensure a clean and controlled environment for aseptic product manufacturing.
- Verify batch records for critical processing steps to ensure accuracy and compliance.
- Perform Growth Promotion testing on prepared media to ensure product quality.
- Oversee and conduct Sterile Media Fill Trials and related support testing to ensure regulatory compliance.
- Maintain cleanliness and organization in Quality Control laboratories to ensure a safe working environment.
- Assist the Quality Control department with daily operations as needed to ensure seamless workflow.
- Author and update Quality Control SOPs to maintain regulatory compliance and ensure accurate documentation.
- Respond promptly to Out of Specification (OOS) results, notifying supervisors and taking appropriate action to resolve issues.
- Collaborate with Manufacturing, Quality Assurance, and Facilities departments to meet company objectives and timelines.
- Utilize various analytical equipment to support product quality assessments and ensure accurate results.
- Train other employees as required on environmental monitoring procedures to ensure a high level of competence within the team.
- Prepare thorough Manufacturing Investigation Reports (MIRs) to identify and address potential issues and root causes.
Requirements:
- Bachelor of Science degree in a scientific discipline (minimum).
- Proficiency in database management, project management tools, spreadsheets, and word processing software.
- Knowledge of Current Good Manufacturing Practices (cGMP) and industry standards.
- Previous experience in a similar role within the biologics or pharmaceutical industry.
- Experience with aseptic processing and mammalian cell culture production.
- Familiarity with basic laboratory equipment such as microscopes, pH meters, and incubators.
- Strong verbal, written, and organizational skills.
- Excellent interpersonal and communication abilities.
- Willingness to work occasional off-shift and weekend hours.
