RHO Inc Director, Quality Control Laboratories in Amityville, New York
Director, Quality Control Laboratories
Responsible for compliance of laboratory operations with established SOPs, FDA regulations as well as compendial requirements.
Ensures thorough investigations are performed leading to the assignment of root causes and the implementation of effective corrective/preventive actions (CAPA) to minimize the possibility of recurrence.
Supports analytical submissions as well as Pre-Approval inspection support. Direct the technical staff of Quality Control and all documentations, which support CMC regulatory submission.
Participates in regulatory agency inspections as required.
Develops and mentors direct and indirect reports.
Directs the generation and implementation of performance and training programs for Quality Control personnel.
Ensures that departmental performance adheres to established performance metrics. Ensures departmental tasks are completed by their established target dates.
Responsible for the assignment of the laboratory disposition of test samples.
Interfaces with R&D and provides feedback on analytical test method development and validation efforts.
Embraces the concept of Continuous Improvement to optimize laboratory performance.
Maintains laboratory operating costs within established budgets.
Implement and revise SOPs as deemed necessary
Responsible for Raw Material, Finished Products and Stability Departments
Must have proven interpersonal skills, and be able to direct the activities of subordinates with a wide range of skill levels.
Well versed in the regulatory requirements (cGMP) of the pharmaceutical industry, and will have demonstrated strength in problem solving and resolution.
Must have strong skills / experience with various types of laboratory testing techniques and instrumentation.
Excellent computer and software skills.
Excellent problem solving aptitude, communication and multi-tasking skills.
Excellent verbal and written communication skills.
Education and Experience:
B.S. / B.A. in Chemistry or related discipline with 10 years' experience in pharmaceutical sciences or
M.S. in Chemistry or other related discipline with 5 years of experience in pharmaceutical sciences.
Minimum of 8 years of demonstrated excellence in chemical and/or pharmaceutical quality (cGMP) with an emphasis on Analytical Testing.
Minimum of 5 years of supervisory or management experience.
Physical Demands and Work Environment:
Requires prolonged sitting. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and vision to record, prepare and communicate appropriate reports.
While performing the duties of the job the employee is frequently required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms as well as being able to lift up to 50 pounds.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Mental Requirements include:
Ability to hear accurately the spoken word with moderate office noise or plant noise
Ability to apply deductive reasoning and understand complicated issues
Ability to receive instructions and follow work rules and company policies
Ability to follow safety and security practices
Ability to meet deadlines and effectively deal with office stress
Ability to accurately communicate ideas, facts and technical information
Maintain confidentiality of certain information
7+ to 10 years' experience
Seniority Level - Director
Management Experience Required - Yes
Minimum Education - Bachelor's Degree
Willingness to Travel – Occasionally
Has a minimum of 10 years of experience in a pharmaceutical industry, liquid dosage preferred.
Minimum of 5 years of management experience over a team of 45 employees or more.
The right candidate will be able to troubleshoot and work hands-on within the lab.