QA Investigation and Compliance Specialist - 2 Openings
Salary undisclosed
Apply on
Original
Simplified
Job Description
Job Description
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists
Hema Malini at 630 847 0275
Meghna at 224 369 4230
Meenakshi at 630 847 1776
Hema Malini at 630 847 0275
Meghna at 224 369 4230
Meenakshi at 630 847 1776
Title: QA Investigation and Compliance Specialist - 2 Openings
Location: Marion, NC
Duration: 2 Months
Location: Marion, NC
Duration: 2 Months
Position Summary
The deviation owner leads the investigation of deviations that occur in operations and is responsible for authoring the investigation summary report. Partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause and corrective and preventive actions. Interacts will all levels of staff and provides status updated as well as present the strategy for closure of deviations. Manage several investigations at a time.
The deviation owner leads the investigation of deviations that occur in operations and is responsible for authoring the investigation summary report. Partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause and corrective and preventive actions. Interacts will all levels of staff and provides status updated as well as present the strategy for closure of deviations. Manage several investigations at a time.
Job Responsibilities:
1. Determine scope, product impact, root cause and corrective actions for deviations from manufacturing procedures. Determine appropriate preventive actions to avoid reoccurrence of the deviation.
2. Conduct personnel interviews to determine root cause of the deviation.
3. Foster collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of deviation generation rate.
4. Set up and run meetings with cross functional teams.
5. Close deviations in a timely manner to meet business and compliance needs.
6. Work with minimal supervision to drive deviations to closure.
7. Work with SME and Quality Approvers to determine the breadth and scope of the investigation to identify the appropriate toot cause, implement corrective and preventive actions, complete trending analysis, and recommend product disposition.
8. Present and defend investigations during regulatory inspections, as required.
9. Sustain a clean and safe work area using 6S principles.
10. Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP)
1. Determine scope, product impact, root cause and corrective actions for deviations from manufacturing procedures. Determine appropriate preventive actions to avoid reoccurrence of the deviation.
2. Conduct personnel interviews to determine root cause of the deviation.
3. Foster collaborative relationships focused on high quality investigations, meaningful corrective actions and the reduction of deviation generation rate.
4. Set up and run meetings with cross functional teams.
5. Close deviations in a timely manner to meet business and compliance needs.
6. Work with minimal supervision to drive deviations to closure.
7. Work with SME and Quality Approvers to determine the breadth and scope of the investigation to identify the appropriate toot cause, implement corrective and preventive actions, complete trending analysis, and recommend product disposition.
8. Present and defend investigations during regulatory inspections, as required.
9. Sustain a clean and safe work area using 6S principles.
10. Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP)
Knowledge, Skill and Abilities
1. Strong communication and project management skills. Must have a thorough understanding of pharmaceutical manufacturing process and equipment, preferably parenteral solutions and current Good Manufacturing Practices (cGMPs). Must have good analysis, troubleshooting, and investigation skills, but uninformed reader can understand and make decisions based on the written investigation report. Must be able to interact with, and influence others at various levels in multiple departments.
2. Understand verbal and written safety and quality instructions and read and comprehend written k instructions including words and drawings.
3. Must have basic English written and oral communication skills adequate to communicate with other team members.
1. Strong communication and project management skills. Must have a thorough understanding of pharmaceutical manufacturing process and equipment, preferably parenteral solutions and current Good Manufacturing Practices (cGMPs). Must have good analysis, troubleshooting, and investigation skills, but uninformed reader can understand and make decisions based on the written investigation report. Must be able to interact with, and influence others at various levels in multiple departments.
2. Understand verbal and written safety and quality instructions and read and comprehend written k instructions including words and drawings.
3. Must have basic English written and oral communication skills adequate to communicate with other team members.
Required Education and Experience
Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering, with 2-3 years of experience in root cause evaluation, interpreting regulations and quality systems. Minimum of 5-8 years of experience in Manufacturing Operations and or Quality, or related field in the medical products industry.
Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering, with 2-3 years of experience in root cause evaluation, interpreting regulations and quality systems. Minimum of 5-8 years of experience in Manufacturing Operations and or Quality, or related field in the medical products industry.
Other Duties as Assigned
This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Overtime is worked as required.
This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Overtime is worked as required.
About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Report this job Similar Jobs
