Manufacturing Associate

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., is a biotechnology company dedicated to reducing suffering and saving lives through the early detection of cancer. Backed by extensive clinical validation, we are advancing one of the most important innovations in modern medicine: detecting cancer at its earliest, most treatable stages through a simple blood draw.

We are looking for a passionate individual to join our Manufacturing team, whose mission is to bring our products into commercial readiness.

This mission critical role is essential to maintaining a GMP compliant, efficient, and safe manufacturing environment that enables cutting-edge diagnostic production and release. The ideal candidate will have experience in cGMP workflows, inventory control, and support of regulatory readiness (e.g., ISO 13485, CLIA, FDA).

Candidates for this position must enjoy working for a fast-paced, innovative company, be able to work in a highly collaborative and teamwork-oriented environment and exhibit a passion for being a part of our life-saving mission.

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 strict adherence to 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 personal protective equipment (PPE) and handling of biological materials

Support controlled material management activities, including issuance of materials and physical inventory counts

Requirements:

Associate or Bachelor’s degree in biological, chemical or physical science, or equivalent experience

Minimum 2 years of experience in a cGMP production environment with degree, ideally within an 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 and move on to the next

Strong familiarity with general laboratory equipment and consumables (pipettes, scales, etc.)

Working knowledge of regulatory standards such as ISO 13485, CLIA, cGMP, QSR is highly desirable

The ability to occasionally lift and move equipment, materials, and supplies weighing up to 50 lbs., stand/walk for extended periods

Lean manufacturing experience, a plus

Comfortable wearing PPE and operating in the presence of low-level biohazards

Proficiency in Microsoft Office

Hiring Manager: Senior Manager, Manufacturing

Location: In Person (Waltham, MA Office)

Status: Full Time

Job ID: MNF003

Base Salary Range: $72,500 – $82,000