Summary: Under limited supervision, analyzes quality issues in production and laboratoriesfor the 3rd shift 11:30pm - 07:30am, and resolves complex work process and engineering issues. Provides support to Director in project coordination, problem solving, and designing process improvement solutions. Develops plans and complex strategies for implementation of corrective and preventative measures. Provides training and work direction to other engineering staff.
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. * Provides work direction and training to subordinate engineering staff, provides technical guidance for complex quality issue resolution.
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.
- Consults with other departments to identify recurrent problems, and coordinates resolution of complex quality issues. * Oversees Annual Product Review System. * Oversees complaint investigation process. * May review, approve and support execution of equipment qualifications, validation protocols and validation master plans.
- Audits quality reports, verifies accuracy, and identifies opportunities for improvement. * Recommends strategies and methods for improving production and laboratory processes. * Analyzes data from production and laboratories, and investigates deviations. * Researches and recommends improvements in production and laboratory systems.
- 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. * May be required to oversee, participate and approve the interviewing, hiring, and training of site departmental employees; conducts performance evaluations for direct reports; and assists direct report managers with performance evaluation process for their units. * 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 aregulated manufacturing environment.
- OSHA, FDA, EPA, AQMD and other applicable 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.
- Preparation, presentation and review of Annual Product Reviews (APR's). * Compilation of data, investigation and review/approval of product complaints. * New and emerging inspection and test technology. * Current Company policies and procedures, including safety rules and regulations.
- English usage, spelling, grammar and punctuation. * Engineering and business computer systems and software applications. * Recruiting, interviewing and selecting applicants in accordance with established employment practices and methods. * Company safety rules and regulations, worker's compensation and related practices.
Minimum Qualifications : Bachelor's Degree in Science, Engineering or related field from an accredited college or university, and a minimum of fourteen (14) - nineteen (19) years related experience preferably in a quality assurance environment; or, an equivalent combination of education and/or experience. Supervisory experience of two (2) years preferred.
- 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. Work is performed in a manufacturing environment. Noise level in this environment is usually moderate.
Watson Pharmaceuticals - 2 years ago