Lead Investigator - Quality & CAPA (Pharma)

SHARP STERILE MANUFACTURING LLC; Lee (MA); On-site; USD 68,000 - 90,000; Full time

Job summary

SHARP STERILE MANUFACTURING LLC in Lee, MA is seeking an Investigator II to conduct investigations into deviations and guide other investigators on complex issues. The role also includes authoring investigations and reports and supporting CAPA activities with cross-functional input.

A technical Bachelor's or Master's degree and four years of post‑degree experience in engineering, cGMP or quality are required, with strong MS Office skills and excellent communication.

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 effective CAPAs.
• Support and participate in client communications and responses related to deviations and investigations, working closely with program team leads, quality, and leadership.
• Facilitate meetings with cross-functional stakeholders to drive alignment, clarify issues, and achieve desired outcomes for deviation investigations.
• Prioritize and manage multiple investigations in a fast-paced environment while meeting quality and timeline expectations.
• Evaluate data trends and perform trend analysis to make informed recommendations that improve quality processes and reduce recurrence of deviations.
• Contribute to continuous improvement of quality assurance processes by sharing insights, lessons learned, and best practices from investigations.

Skills

MS Office proficiency

cGMP familiarity

engineering concepts

time management

attention to detail

well-organized

communication skills

Education

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

equivalent education/experience considered

Tools

MS Office

Adobe Acrobat

Job description

SHARP STERILE MANUFACTURING LLC in Lee, MA is seeking an Investigator II to conduct investigations into deviations and guide other investigators on complex issues. The role also includes authoring investigations and reports and supporting CAPA activities with cross-functional input.

A technical Bachelor's or Master's degree and four years of post‑degree experience in engineering, cGMP or quality are required, with strong MS Office skills and excellent communication.