COMPLIANCE INVESTIGATOR

Regular
16 Elkins, East Brunswick
Posted 3 months ago

Job Summary:
The compliance investigator is responsible for investigating, handling, reporting, and documentation of deviations, non-conformances, and complaints in the operations department. Interact and effectively communicate with subject matter experts (SME) from all departments to determine root cause and appropriate CAPA. Support Compliance and Quality Assurance management in maintaining and improving cGMP quality Systems. Investigator will assist Qualification Engineer with the development, and review of protocols/reports related to the IT-Manufacturing department. The Compliance Investigator will directly report to the Director of Operations and will assist throughout the manufacturing documentation when necessary.

Reporting Relationships
• This person is expected to work under minimal supervision. Work is reviewed upon completion for adequacy in meeting objectives. This position has no direct reports.
Essential Functions:
• Initiate deviations, complaints investigations as and when they are notified.
• Perform Root Cause Analysis (RCA) investigations and impact/risk assessments in response to deviations, OOS results, non-conforming events, and Customer Complaints.
• As part of each investigation, gather information from all necessary internal and external sources in order to find the root cause and to evaluate the impact of the deviation on the manufactured products, as well as the risk to previous products/future operations.
• The investigator will conduct and drive nonconformance events/deviations to identify root cause, product impact, and preventative actions for Manufacturing Operations in support of batch disposition and continuous process improvement. Work with internal teams to obtain an in-depth understanding of the product and the documentation requirements.
• Work across functions in a professional manner to conduct investigations and work independently to comply with procedure driven guidelines relating to deviation investigations.
• Produce high-quality investigation documentation that meets applicable standards and is appropriate for its intended audience. • Properly assess the manufacturing or analytical environment and independently conceives and initiates appropriate corrective/preventative actions (CAPAs) designed to mitigate Quality deficiencies identified in the investigative process using analytical tools.
• Conduct training to employees based on the deviations/CAPAs.
• Track the progress of the open CAPAs and ensure closure of the CAPAs in a timely manner.
• Provides technical assistance to area supervisors or managers to solve complex problems. Exercises judgment in developing practices, techniques, and evaluation criteria for obtaining results.
• Prepare monthly, quarterly and annual investigations/CAPAs trend reports.
• Discover and report any trends in reported deviations/investigations.
• Conduct training to employees based on the deviations/CAPAs.
• Authors, and reviews Protocols and subsequently develops protocol reports to support manufacturing/packaging events, deviations/CAPA’s/OOS.
• Initiate change controls for manufacturing-related operations. Author departmental Standard Operating Procedures (SOPs), Protocols, technical reports, etc.
• Assist Qualification/CVS Engineer with development, review, and execution of protocols/reports and other qualification documents related to the IT-Manufacturing department.
• Assist Compliance management with the development and implementation of continuous quality improvement plans
• Support Compliance and Quality Assurance in maintaining and improving cGMP quality Systems
• Perform quality system audits to ensure compliance with company SOPs and cGMPs
• Generate trend reports for investigation, non-conforming events and CAPAs. Discover and report any trends.
• Other duties as assigned

.
Specialized Skills and Knowledge:
• Education/Certifications:
o BA/BS Degree in the science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience; 3-5 years of pharmaceutical or related work experience with an emphasis on current Good Manufacturing Practices including Manufacturing, Validation, and Process engineering.
o Pharmaceutical or related FDA work experience strongly preferred.
• Must know the operation of pharmaceutical production equipment.
• Experience in solid dosage manufacturing, process, and quality.
• Demonstrates strong analytical and technical skills.
• Ability to articulate, discuss and glean information from Manufacturing, QC, QA, RA and engineering personnel to write a complete investigation.
• Excellent verbal communication and strong written English skills with a proven record of producing technical reports in a clear and concise manner.
• Strong experience and comprehension of MS Office programs — primarily MS Word and Excel.
• Experience in statistical process control is a plus.
• Assures compliance to all procedures and policies concerning all areas of manufacturing, logistics, safety, and human resources.
• Must be able to work in fast-paced environment.
• Previous technical writing experience required.
• Other duties as assigned.

Key Competencies:
1. Critical thinking and Problem solving
2. Writing and research skills
3. Attention to detail

Physical Demands/Factors:

Work is primarily sedentary in nature; routine bending, walking, lifting, and reaching are required. Employee may be required to lift up to 25 lbs. and stand in a production environment continuously.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Avet is proud to be an Equal Opportunity Employer.


This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

Job Features

Job CategoryManufacturing

Apply Online