Manufacturing Associate II

Scorpion Therapeutics; Worcester (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Scorpion Therapeutics is seeking an experienced manufacturing operator to perform assembly, labeling, packaging, and inspection per approved procedures and schedules. You will independently execute GMP/GDP-compliant operations and maintain accurate batch records.

You will set up and troubleshoot equipment, perform inspections, and support deviations, CAPAs, and root-cause analyses. Collaboration with QA/QC and other teams is essential.

Qualifications

• Working knowledge of cGMP, GDP, and quality system requirements.
• Proficiency in manufacturing documentation and batch record execution.
• Ability to operate/troubleshoot manufacturing and packaging equipment.
• Attention to detail; commitment to product quality.
• Organizational and problem-solving skills; strong verbal/written communication.
• Basic proficiency with electronic quality management systems (preferred).
• Ability to train others; work independently with limited supervision.
• Lift up to 25 lbs; wear required PPE including cleanroom gowning.
• Ability to stand, walk, bend, reach, and perform repetitive motions for extended periods; requires an eye exam.
• Experience: 2–5 years in a regulated manufacturing environment; medical device/pharma/biotech/combination product manufacturing (required). GMP equipment operation/documentation (preferred).
• Education: High School Diploma or GED required; associate degree/technical certification/coursework in related fields (preferred).

Responsibilities

• Perform manufacturing, assembly, labeling, packaging, and inspection activities per approved procedures and production schedules.
• Independently execute manufacturing operations in compliance with GMP, GDP, and company standards.
• Complete batch records, logbooks, and other production documentation accurately and contemporaneously.
• Set up, operate, troubleshoot, and perform basic maintenance on manufacturing equipment.
• Conduct in-process inspections and verify product quality.
• Perform line clearances, room preparation, product changeovers, and equipment setup.
• Assist with material handling (staging, issuing, reconciliation of in-process materials and finished goods).
• Identify and elevate process deviations, equipment issues, quality concerns, and safety risks.
• Support deviation investigations, nonconformance activities, CAPAs, and root cause analyses.
• Participate in process validation, equipment qualification, and manufacturing engineering activities as required.
• Train/mentor junior personnel.
• Support continuous improvement for quality, efficiency, productivity, and compliance.
• Collaborate with QA, QC, Engineering, Supply Chain, and other teams.
• Maintain production areas and equipment in inspection-ready condition.
• Comply with company safety policies, GMP regulations, and training requirements.

Skills

cGMP knowledge

Quality systems

Documentation proficiency

Equipment troubleshooting

Attention to detail

Communication skills

Training others

Independent work

PPE compliance

Problem solving

Education

High School Diploma or GED

Associate degree/technical certification

Tools

Electronic quality management systems

Job description

Responsibilities:

• Perform manufacturing, assembly, labeling, packaging, and inspection activities per approved procedures and production schedules.
• Independently execute manufacturing operations in compliance with GMP, GDP, and company standards.
• Complete batch records, logbooks, and other production documentation accurately and contemporaneously.
• Set up, operate, troubleshoot, and perform basic maintenance on manufacturing equipment.
• Conduct in-process inspections and verify product quality.
• Perform line clearances, room preparation, product changeovers, and equipment setup.
• Assist with material handling (staging, issuing, reconciliation of in-process materials and finished goods).
• Identify and elevate process deviations, equipment issues, quality concerns, and safety risks.
• Support deviation investigations, nonconformance activities, CAPAs, and root cause analyses.
• Participate in process validation, equipment qualification, and manufacturing engineering activities as required.
• Train/mentor junior personnel.
• Support continuous improvement for quality, efficiency, productivity, and compliance.
• Collaborate with QA, QC, Engineering, Supply Chain, and other teams.
• Maintain production areas and equipment in inspection-ready condition.
• Comply with company safety policies, GMP regulations, and training requirements.

Required/Preferred Skills & Qualifications:

• Working knowledge of cGMP, GDP, and quality system requirements.
• Proficiency in manufacturing documentation and batch record execution.
• Ability to operate/troubleshoot manufacturing and packaging equipment.
• Attention to detail; commitment to product quality.
• Organizational and problem-solving skills; strong verbal/written communication.
• Basic proficiency with electronic quality management systems (preferred).
• Ability to train others; work independently with limited supervision.
• Lift up to 25 lbs; wear required PPE including cleanroom gowning.
• Ability to stand, walk, bend, reach, and perform repetitive motions for extended periods; requires an eye exam.
• Experience: 2–5 years in a regulated manufacturing environment; medical device/pharma/biotech/combination product manufacturing (required). GMP equipment operation/documentation (preferred).
• Education: High School Diploma or GED required; associate degree/technical certification/coursework in related fields (preferred).