GMP Manufacturing Associate — Biotech Operations (Onsite)

Mercy BioAnalytics; Waltham (MA); On-site; USD 73,000 - 82,000; Full time

Job summary

Mercy BioAnalytics, Inc. in Waltham, MA is seeking a Manufacturing professional to support cGMP production, labeling, dispensing, and documentation to keep operations compliant and efficient.

You will collaborate with Quality, Development, Supply Chain and Operations, participate in equipment qualification and process validation, and help maintain an inspection-ready environment.

This full-time role requires a degree in a science field and experience in ISO 13485, CLIA, or FDA contexts.

Qualifications

• Associate or Bachelor’s degree in a biological, chemical or physical science, or equivalent experience.
• Minimum 2 years of experience in a cGMP production environment with degree, ideally ISO regulated setting.
• Strong organizational and multitasking skills with attention to detail.
• Comfortable working in a dynamic environment where priorities can shift quickly.
• Excellent communicator with a proactive, can-do attitude and ability to work cross-functionally.
• Strong time management skills to efficiently complete manufacturing tasks.

Responsibilities

• Execute day-to-day manufacturing operations including label printing, labelling, formulations and dispensing in accordance with cGMP requirements and standards.
• Prepare, set up, clean and maintain cGMP spaces and equipment and materials before and after manufacturing operations.
• Perform routine and critical manufacturing activities in accordance with work instructions and SOPs while maintaining quality and documentation requirements.
• Maintain a clean, organized, and inspection ready manufacturing environment in compliance with cGMP, ISO 13485, FDA QSR and applicable regulatory requirements.
• Support controlled material management activities including material issuance, reconciliation, inventory counts, and inventory accuracy.
• Identify, document and communicate production non-conformances, deviations, and quality events in accordance with quality system requirements.
• Complete batch records, logs, and other documentation in a timely and accurate manner.
• Collaborate closely with Quality, Development, Supply Chain and Operations teams to support Manufacturing objectives and product efforts.
• Participate in equipment qualification, process validation, and continuous improvement initiatives to improve manufacturing efficiency, scalability and robustness.
• Follow all safety protocols and maintain a safe working environment including appropriate use of PPE and handling of biological materials.
• Support controlled material management activities, including issuance of materials and physical inventory counts

Skills

cGMP

Documentation

Regulatory standards

Microsoft Office

Communication

Cross-functional collaboration

Education

Associate or Bachelor’s degree in biological/chemical/physical science

Tools

Pipettes

Scales

General laboratory equipment

Job description

Mercy BioAnalytics, Inc. in Waltham, MA is seeking a Manufacturing professional to support cGMP production, labeling, dispensing, and documentation to keep operations compliant and efficient.

You will collaborate with Quality, Development, Supply Chain and Operations, participate in equipment qualification and process validation, and help maintain an inspection-ready environment.

This full-time role requires a degree in a science field and experience in ISO 13485, CLIA, or FDA contexts.