Senior Investigator II - Deviations & CAPA Lead

Sharp Services, LLC; Lee, Northern (MA, KY); Hybrid; USD 68,000 - 90,000; Full time

Job summary

Sharp Services, LLC is seeking an Investigator II in Lee, MA, to lead investigations into deviations and guide peers in quality processes. You will author reports, manage cross-functional input, and drive corrective actions while communicating with clients and program leadership.

The role emphasizes adherence to cGMPs, regulatory expectations, and continuous improvement on the manufacturing floor. A technical degree and 4 years of related experience are preferred, with strong MS Office skills.

Qualifications

• Four (4) years of relevant post-degree work experience in engineering, cGMP or quality positions.
• Bachelor’s or Master’s degree in a technical field preferred.
• Familiarity with regulatory requirements in the pharmaceutical or related fields.

Responsibilities

• Lead cross-functional teams in investigation of equipment and deviations.
• Author deviation investigations and reports within required timeframes.
• Manage timely review and investigation of deviation queries from internal and external sources.
• Develop and implement CAPAs with input from engineering, quality, and manufacturing.
• Support client communications and responses related to deviations and investigations.
• Facilitate meetings to align stakeholders and drive investigation outcomes.
• Prioritize multiple investigations in a fast-paced environment.
• Perform trend analysis to improve quality processes and reduce deviations.

Skills

MS Office proficiency

Analytical thinking

Attention to detail

Strong communication

Education

Bachelor’s or Master’s in a technical field

Tools

MS Office

Job description

Sharp Services, LLC is seeking an Investigator II in Lee, MA, to lead investigations into deviations and guide peers in quality processes. You will author reports, manage cross-functional input, and drive corrective actions while communicating with clients and program leadership.

The role emphasizes adherence to cGMPs, regulatory expectations, and continuous improvement on the manufacturing floor. A technical degree and 4 years of related experience are preferred, with strong MS Office skills.