Responsible for processing complaints to ensure quality and compliance with all SOPs, cGMP, company policies as well as FDA and other government and safety regulations by performing the following duties.
The primary responsibilities will be to complete complaint reports per the complaint template and governing site procedures.
The QA specialist will be responsible for processing and closing complaints in a timely manner. Approves the complaint reports per the site procedure. Initiates incidents in the investigation system per site procedures as required, i.e. if the complaint has a manufacturing root cause. Additional responsibilities my include write or assisting with manufacturing investigation when required.
Work with the QA manager to resolve issues associated with complaints or the complaint system.
- Process and close complaints investigation reports in a timely manner.
- Initiates incidents in the investigation system per site procedures
- Approves the complaint reports per the site procedure
- Interprets generated data and communicate results to Quality management. Maintain effective communication and partnership with Operations department.
- Interacts with production, technical services, engineering, QC as part of the investigaiton process
- Three years related QA experience in a manufacturing environment.
- Strong understanding of cGMP concepts and requirements.
- Must be able to read, write, speak, and understand fluent English. Basic fundamental understanding of mathematics.
- Intermediate knowledge of MS Office.
- Able to demonstrate accuracy and thoroughness while completing work in a timely manner. Follows instructions, policies, and procedures.
- Non-Essential Skills: Able to speak effectively before small to moderate sized groups.
- Two year certificate from college or technical school
- Bachelors degree in sciences, chemistry, biology or engineering preferred
Physical Demands: While performing the duties of this job, the employee is regularly required to sit in position for long times, minimum lifting is required.
Years of Experience 0-3 with a bachelors degree, 3-5 with an associate degree.