Home

A Division of

GMP Publications
& FDA.COM
"The GxP Family of
Quality Business"

Email Your Resume Now!   

For Job Seekers  |   <Job Listings  |  For Employers  |  Company   

"We stand on a higher pillar of excellence!"

Title Location Type Rate Apply
Sr. Manager/Assoc. Director, QC  Orlando FL  Perm/Full $70,000 - $100,000

Submit

Sr. Manager/Assoc. Director, QC 
• Plans, organizes, and manages resources on projects to assure technical and regulatory quality, budget and schedule adherence.
• Conceives, directs, plans, designs, and executes method development, method validation, and testing for formulation development and cGMP quality control activities.
• Oversee Quality Control Chemistry Laboratory and assure operations are conducted in accordance with regulatory requirements and expectations.
• Initiates hiring, performance reviews, and staff development activities to improve technical and management capabilities.
• Develop and approve methods and results including: product specifications; protocols, SOPs, and reports for analytical method validation and stability studies; IQ/OQ/PQ protocols and reports for equipment; master production records.
• Responsible for effective written, verbal, and interpersonal interactions with external clients and internal project teams.
• Assists staff in developing solutions to complex technical and regulatory problems and investigation of unexpected results. Participate in client and regulatory audits of facilities and quality system.
• Participate in strategic and product development planning.
• Design and implement new methodologies to increase efficiencies and productivity

Experience:
• Minimum of Bachelors degree and 10 years of experience working in Quality Control Chemistry and/or Research & Development.
• Experience with cGMP documentation systems and with implementation of quality control systems.
• Strong knowledge of FDA manufacturing/regulatory quality systems regulations, qualification, facilities and investigation requirements.
• Must have strong project management skills and be able to provide technical vision and direction with compliance to standards in order to meet business initiatives.
• Must possess direct experience in analytical method development, transfer and validation.
• Must possess a strong experience base in product QC testing and release procedures/documentation.
• Must be detailed oriented and have excellent organizational skills.
• Must possess effective written and oral communication skills and be able to handle multiple projects within limited time frames.
• It is expected that the incumbent will have skills in HPLC, GC, and mass spectroscopy detection technologies. Familiarity with cGMP and regulatory guidance is also required. Excellent communication and technical writing skills are essential in order that this person can effectively work with multiple teams simultaneously in a highly matrixed environment. The colleague is expected to be a leader in the technology area and to train others for more routine and specific project-oriented applications.