Lead Investigator: Deviations & CAPA

Berkshire Sterile Manufacturing Llc; Lee (MA); On-site; USD 68,000 - 90,000; Full time

Job summary

Berkshire Sterile Manufacturing Llc is hiring an Investigator II in Lee, MA to conduct deviations investigations and guide other investigators. You will lead cross-functional teams, author investigations, and drive CAPAs within GMP guidelines.

Requires a technical degree and 4+ years post-degree experience in engineering or quality roles, with strong MS Office skills and solid communication abilities. The role emphasizes timely reporting, client interactions, and continuous QA improvement.

Qualifications

• Four (4) years of relevant post-degree work experience in an Engineering, cGMP or quality position.
• Bachelor’s or Master’s degree in a technical field preferred.
• An equivalent combination of education and experience may be considered.

Responsibilities

• Lead cross functional teams in the investigation of equipment and complex deviations.
• Author deviation investigations and associated reports within required timeframes.
• Manage the timely review and investigation of and respond to deviation queries from internal and external sources.
• Collaborate with various departments to gather information, evaluate causal factors, and develop and implement CAPAs.
• Support and participate in client communications and responses related to deviations and investigations.
• Facilitate meetings with cross-functional stakeholders to drive alignment and outcomes.
• Prioritize and manage multiple investigations in a fast-paced environment.
• Evaluate data trends and perform trend analysis to improve quality processes.
• Contribute to continuous improvement of quality assurance processes.
• Interface with Engineering, Quality, Materials, Manufacturing, and Project Management.
• Observe and investigate on the manufacturing floor and mechanical areas.
• Assist in compiling information for KPI.
• Attend and complete all mandatory training.
• Demonstrate SSM values and behaviors at all times.
• Other duties as assigned.

Skills

Investigations

CAPA development

Cross-functional collaboration

Regulatory compliance

Attention to detail

Time management

Oral & written communication

Education

Bachelor’s or Master’s degree in a technical field

Equivalent combination of education and experience

Tools

MS Office

Job description

Berkshire Sterile Manufacturing Llc is hiring an Investigator II in Lee, MA to conduct deviations investigations and guide other investigators. You will lead cross-functional teams, author investigations, and drive CAPAs within GMP guidelines.

Requires a technical degree and 4+ years post-degree experience in engineering or quality roles, with strong MS Office skills and solid communication abilities. The role emphasizes timely reporting, client interactions, and continuous QA improvement.