Investigator II

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time Technical Lee, MA, US

3 days ago Requisition ID: 1812

Salary Range: $68,000.00 To $90,000.00 Annually

Position Summary

The Investigator II is a hands-on role responsible for conducting investigations and providing guidance to other investigators related to deviations.

Duties and 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 corrective and preventive actions (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.
• Interface with Engineering, Quality, Materials, Manufacturing, and Project Management.
• Observe and investigate on the manufacturing floor and mechanical areas.
• Assist in compiling information for the Key Performance Indicators (KPI) on an as needed basis
• Attend and complete all mandatory training
• Demonstrate SSM values and behaviors at all times
• Other duties as assigned

Regulatory Responsibilities

• Support Manufacturing Investigation function during FDA, corporate GMPs and customers compliance audits
• Participate in internal audits as applicable
• Provide leadership in daily operations to other investigators

Experience

• Four (4) years of relevant post - degree work experience in an Engineering, cGMP or quality position

Education

• Bachelor’s or Master’s degree in a technical field preferred
• An equivalent combination of education and experience may be considered

Knowledge, Skills & Abilities

• Proficient in the use of MS office applications such as Word, Excel, PowerPoint and Adobe Acrobat
• Basic understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
• Familiarity of engineering concepts
• Time management
• Attention to detail whileexecuting multiple tasks
• Well - organized
• Good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills

Physical Requirements

• Frequent standing and walking throughout the facility