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Founded in 1968, Reliable Biopharmaceutical provides the pharmaceutical and biotechnology industries with the highest quality products available. Our clients profit from our ability to do contract process development and produce bulk pharmaceutical intermediates. We work under current Good Manufacturing Practices (cGMP) and FDA Drug Master Files.
Quality Assurance manager
In this quality role, you will assure consistent quality of production by developing and enforcing current Good Manufacturing Practice (cGMP) systems. You will also validate processes, provide documentation and develop, implement and coordinate product assurance program to prevent or eliminate defects in new or existing products.
Responsibilities: Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements and implementing change. Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures and monitoring inventories. Validates quality processes by establishing product specifications and quality attributes, measuring production, documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures. Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits, investigating customer complaints and collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods. Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations. Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures. Visits and confers with representatives of material and component vendors to obtain information related to supply quality, capacity of vendor to meet orders, and vendor quality standards. Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry.
Qualifications: Bachelor’s or Master’s degree in Chemistry or a related scientific field required 5+ years of relevant experience and/or training Strong knowledge of process improvement with the ability to analyze information, develop strategic plans and emphasize excellence Experience supervising a team, which involved the following: Interviewing, hiring, and training; Planning, assigning, and directing work; Rewarding and disciplining; Appraising performance Excellent verbal communication skills developed from experience resolving complex issues and addressing internal and external complaints Must be meticulous and possessing of a strong attention to detail Technically proficient with MS Office Suite and manufacturing and database software
We value our employees’ time and efforts. We work to maintain the best possible environment, where people can learn and grow with the company. We strive to provide a collaborative, creative atmosphere so that each person feels encouraged to contribute to our processes, decisions, planning and culture. Our commitment to your success is enhanced by a competitive salary and an extensive benefits package that includes the following: 401K plan Medical, dental and vision benefits Paid time off (PTO) Future growth opportunities and much more!
*Please note that Reliable Biopharmaceutical’s recruiting and application processing is being performed through Insperity; therefore, you will be contacted by an Insperity Recruiting Specialist IF and when you are considered for this position