What are the responsibilities and job description for the Investigator II position at SHARP STERILE MANUFACTURING LLC?
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
Supervisory Responsibilities
- 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
- Associates degree
- 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 while executing 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
- Satisfactory audio-visual acuity
Salary : $68,000 - $90,000