Summary: Under general supervision, in the Laboratory reviews and approves technical reports to ensure accuracy and compliance to rules and regulations related to process development, validation and optimization. Generates Annual Product Review Reports, leads investigations into product complaints and writes final complaint investigation reports. Monitors and trends key areas and indicators from production and laboratories. Develops plans for implementation of corrective and preventative measures.
Essential Job Functions: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks. * Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. * Review and approve Technical Reports to: *ensure accuracy and compliance to pharmaceutical rules and regulationsas related to process development, validation and optimization * Monitors activities in key areas for compliance to standards, and identifies opportunities for improvement.
Work is performed in a manufacturing environment. Noise level in this environment is usually moderate. Minimum Qualifications: Bachelor's Degree in Science, Engineering or related field from an accredited college or university, and nine (9) - thirteen (13) years related experience preferably in a quality assurance environment; or, an equivalent combination of education and/or experience. Some supervisory experience preferred.
- Analyzes data from production and laboratories, and reports deviations. * Researches and recommends improvements in production and laboratory systems. * Generates Annual Product Review Reports. * Writes complaint investigation responses.
- Helps direct junior level QA Engineering staff in completion of assignments. * Complies with all Company policies and procedures, including safety rules and regulations. Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements in a regulated manufacturing environment. * Performs related duties as assigned.Required Knowledge and Skills : Knowledge of : * Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements in a regulated manufacturing environment.
- OSHA, FDA, EPA, AQMD and other regulatory and safety compliance guidelines. * Investigations to determine cause, corrective action and prevention planning. * Applied cGMP's and Company systems. * Laboratory equipment and testing.
- Auditing techniques in a regulated environment. * Applied statistics and trend analysis. * Pharmaceutical manufacturing, its customers, competition and market. * Pharmaceutical manufacturing suppliers, raw materials and products.
- New and emerging inspection and test technology. * English usage, spelling, grammar and punctuation. * Engineering and business computer systems and software applications. Skill in: * Developing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
- Managing and conducting projects and assignments in a cost effective and timely manner. * Analyzing and troubleshooting problems, identifying solutions, and recommending and implementing methods, procedures, systems and/or techniques for resolution. * Writing clear and concise technical reports. * Working with attention to detail, and independently with minimal supervision.
- Managing multiple projects. * Communicating clearly and concisely, both orally and in writing. * Establishing and maintaining effective working relationships with individuals contacted in the course of work. * Utilizing a computer and standard business and engineering software.Physical Requirements and Working Conditions: Requires the ability to stand and walk for moderate periods, sit, communicate via telephone, computer and/or face-to-face contact, vision to monitor, and use basic office equipment such as a personal computer, copier and FAX machines regularly in the course of work.