Investigator II

Berkshire Sterile Manufacturing Llc; Lee (MA); Presencial; USD 68.000 - 90.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Investigations

CAPA development

Cross-functional collaboration

Regulatory compliance

Attention to detail

Time management

Oral & written communication

Educación

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

Equivalent combination of education and experience

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

4 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