QA Inspector 3rd shift
160 Pharma Dr Morrisville, NC 27560
- 3rd shift - 10 pm - 6: 30 am*
Associate Quality Assurance Inspectors
Position Overview: Leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Client develops, manufactures and packages pharmaceutical and other products for customers in nearly 100 countries, employs approximately 8, 000 employees at 30 facilities worldwide and generates more than $1.7 billion in annual revenue. Among its core offerings, develops and manufactures oral and sterile pharmaceuticals in nearly all major dosage forms, and offers proprietary technologies used in many well-known prescriptions and over-the-counter products. The largest contract packager of pharmaceuticals.
Essential Functions: Associate Quality Assurance Inspectors supporting manufacturing facility inspection operations. Candidate should have prior GMP inspection experience within a pharmaceutical manufacturing facility or equivalent. Candidate must be detail oriented in a fast-paced multi-task environment with good oral and written communication skills and have the ability to interact with all levels of management and all departments. In-line inspection of packaged finished product samples. Provide QA support to manufacturing for clinical and commercial batches. Performs Line Clearances, equipment releases and AQL inspections. Audit of raw materials and facility logs. Interdepartmental communication for obtaining information. Comply with and ensure compliance of the department with Health, Safety, and Environmental responsibilities. Assist with batch investigations as required. Rotational weekend work to support manufacturing as required.
Requirements: BA or BS in Chemistry or other related sciences nice to have, but not required. Good understanding of compliance, regulations, and inspection techniques. Thorough knowledge of cGMPs, ability to evaluate facilities records, processes, procedures, and practices for conformance to these requirements. One to three years working in the pharmaceutical industry in Quality Assurance. Must have knowledge of current industry expectations of analytical testing requirements for primary and secondary packaging components. Understanding of statistical sampling methodologies Ability to organize time for multiple tasks (major projects and daily functions) handle multiple projects and deliver on project timelines with little supervision Delivers assigned tasks on time Schedules and executes work Function and problem solve independently without supervision Knowledge of cGMP, GLP, ICH, and USP regulations or guidelines for US (FDA) and other regulatory bodies (EU, Health Canada, etc. Flexibility to work every other weekend as part of standard shift and additional hours as needed.