Microbiology Sterility Director at SGS North America Inc.

Posted in Other 24 days ago.

This job brought to you by CareerBuilder

Location: Lincolnshire, Illinois





Job Description:
Company Description

SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

Job Description

The Microbiology/Sterility Assurance Director is responsible for ensuring that the department is functioning in a manner that both satisfies the scientific and business needs of SGS clients and complies with applicable regulatory requirements and Department policies. The Director's duties in some ways overlap with those of the Department Manager. However, in addition to various day-to-day managerial tasks, the Director is ultimately responsible for taking into account big picture considerations and then making those decisions which are crucial to the department's long-term success. Duties include structuring and coordinating the efforts of the technical staff, anticipating and directing the resolution of any problems that may arise during testing, cultivating long-term relationships with clients, handling client complaints and concerns effectively, participating in the development and approval process for SOPs and protocols, taking the lead in the hiring of new staff, organizing training activities, and conducting annual performance evaluations for Department Managers.
SPECIFIC RESPONSIBILITIES
OUR PROMISE TO OUR CUSTOMERS
• At all times, comply with SGS Code of Integrity and Professional Conduct, and to conduct all our testing to to the highest level of cGMP compliance.
SERVICE RESPONSIBILITIES TO CLIENTS
• Serve as a technical expert providing scientific advice and leadership as needed.
• Develop, implement, and maintain systems to ensure that SGS clients receive top-notch customer service from the Microbiology/Sterility Assurance department.
• Ensure that all client requests for microbiology and sterility testing information or quotes (or information regarding any of SGS other services) are met in a timely and effective manner.
• Develop, implement, and maintain systems to ensure that established parameters governing turnaround time, quality specifications, etc. are met on a consistent basis in the Microbiology and Sterility laboratories.
• Ensure that client requests pertaining to the development and completion of specialized studies are met in a timely and effective manner.
• Ensure that client complaints are dealt with effectively according to applicable SGS SOPs.
• Play a lead role in Departmental and company-wide projects designed to improve the nature of SGS client services.
• Work to cultivate long-term relationships with clients based on a combination of technical expertise, scientific knowledge, and professional integrity.
• Represent Company and Company policies as needed during client visits and regulatory agency inspections.
SERVICE RESPONSIBILITIES TO INTERNAL CUSTOMERS
• Serve as a technical expert providing scientific advice and leadership as needed.
• Ensure that all reasonable requests from the General Manager of SGS Life Science Services pertaining to the conduct of a given test or group of tests are met in a timely and effective manner.
• Ensure that all Analysts working in the Microbiology and Sterility laboratories have the resources required to successfully complete their studies.
• Notify the corporate QA Department whenever regulatory affairs issues pertaining to sterility testing need to be addressed.
• Notify Department Admin. Team Leader of any special requests or general concerns regarding sample log-in, reporting, and billing activities.
• Play a lead role in Departmental or company-wide projects designed to improve the internal efficiency and overall quality of work performed at the laboratory.
• Play a lead role in creating and maintaining a positive atmosphere of teamwork throughout the laboratory.
TECHNICAL RESPONSIBILITIES
• Provide microbiology and sterility testing expertise to clients and staff.
• Independently author protocols and reports.
• Maintain thorough knowledge and understanding of current standards and methods pertaining to microbiology and sterility testing at SGS.
• Maintain thorough knowledge and understanding of all SOPs pertaining to the microbiology and sterility laboratories.
• Maintain thorough knowledge and understanding of GMP/GLP and ISO requirements as these pertain to work performed in the microbiology and sterility laboratories.
• Be capable of acting as a Microbiologist for all routine analytical studies, as well as certain advanced or specialized studies as requested by clients. Duties here include test scheduling, test preparation, proper application of procedures, data collection and recording, and approval of final report of analysis.
• Periodically attend industry trade shows and seminars to both increase knowledge and meet with prospective clients.
• Play a lead role in the development and approval of Department SOPs and unique study protocols.
ADMINISTRATIVE RESPONSIBILITIES
• Adherence to all SGS personnel policies.
• Adherence to relevant SGS SOPs related to the handling of client reporting.
• Compliance with applicable SGS SOPs related to the handling of client complaints.
• Participation in general staff training sessions as these are scheduled.
MANAGERIAL RESPONSIBILITIES
• Oversee the efforts of Department Managers to structure and organize Departmental activities in all areas related to testing such as scheduling, preparedness for testing, conduct of testing activities, and reporting.
• Approves laboratory investigations regarding the finding of unexpected results.
• Together with the Department Managers, conduct annual performance evaluations of all Department staff.
• Conduct annual performance evaluations of Department Managers.

Qualifications

• An undergraduate (B.S.) degree in Microbiology, Biology, Engineering or related discipline is required; an advanced degree (M.S. or Ph.D.) is preferred.
• Thorough knowledge of current industry standards and practices regarding testing of pharmaceutical and/or medical device products is required.
• Experience interacting with regulatory agencies (e.g. FDA, notified bodies, etc.).
• A minimum of 5 years of direct people management experience is required.
• Job require mobile use of hands and arms. Reasonable accommodations will be made for persons with disabilities.
• Must be capable of working at a desk and computer terminal for up to three hours at a time, and for up to eight hours on a given day.
REQUIRED SKILLS
• Excellent language, communication, and supervisory skills required.
• Interacts effectively with subordinates, colleagues, superiors and clients.
• Must be able to clearly communicate priorities and responsibilities on a daily basis.
• Solid leadership skills are essential along with good listening skills.
• Must be able to build consensus among a group of individuals.
• Must be capable of working with persons from diverse backgrounds.


Sponsors