Investigator II

Sharp Services, LLC; Lee, Northern (MA, KY); Híbrido; USD 68.000 - 90.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

MS Office proficiency

Analytical thinking

Attention to detail

Strong communication

Educación

Bachelor’s or Master’s in a technical field

Herramientas

MS Office

Descripción del empleo

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

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