What are the responsibilities and job description for the Quality Investigator position at Apace Ky LLC?
The Quality Investigator will be responsible for performing detailed and timely investigations as well as managing complaints, nonconformances and other incidents. This individual should develop relationships with leadership and other staff across all departments, as well as Quality representatives to aid in investigations using continuous improvement techniques, identifying root causes and implementing appropriate corrective and preventive actions. The investigator must have experience in environmental monitoring and a good working knowledge of applicable cGMP and FDA requirements. This individual will be self-motivated and capable of working independently, as well as within a group setting. Previous experience compiling trend data is a plus.
Requirements:
Essential Duties and Responsibilities
1. Assist in performing Annual cGMP Training.
2. Provides thorough, detailed, and timely investigations.
3. Assists in upgrades to all regulatory documentations and forms when needed.
4. Create Annual Process Reviews.
5. Perform risk assessments to determine safety and efficacy of product.
6. Perform routine audits of processes and gap analysis as needed.
7. Facilitate investigations using continuous improvement techniques.
8. Ability to compile data to monitor and identify trends.
9. Follows cGMP Compliance and adheres to regulatory policies.
10. Identify root cause and implement appropriate CAPAs.
11. Approves/Maintains Deviations and Non-Conformances.
12. Participate in Management related meetings when needed.
13. Working knowledge of environmental monitoring and applicable cGMP and FDA requirements.
14. Root cause analysis capabilities
15. Make recommendations for disposition of materials from investigational data.
16. Perform any job within our capabilities that needs doing to secure our customers get the products and service they deserve.
Supervisory Responsibilities
None
Qualifications
Skills in Microsoft Word, Excel, as well as other basic computer functions
Ability to learn and while maintaining integrity with peers during investigation process.
Ability to document properly and train mistakes in a professional manner when requested.
Must have great attention to detail and a results driven work ethic.
Education and/or Experience
High School Diploma, bachelor’s degree or equivalent work experience preferred
Language Skills
English
Mathematical Skills
Excellent reasoning ability and math skills are necessary for regulatory compliance.
Reasoning Ability
Ability to ask and learn is a must
Certificates, Licenses, Registrations, Misc…
Certification of quality control is a strong advantage (ISO 9000 etc.).
Physical Demands
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.
While performing the duties of this job, the employee is regularly required to use hands and fingers to handle or feel. The employee frequently is required to stand, walk, sit, reach with hands and arms, and talk or hear. The employee is occasionally required to climb or balance and stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 20 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
