Leads and assists in Quality Assurance related projects and day to day quality activities as needed. Represents the highest level of GMP understanding and accomplishment.
ESSENTIAL DUTIES AND RESPONSIBILITIES: Supports the Quality Assurance department in the following functions/projects. Will have responsibility for generating or reviewing and approving the following document types.
- Equipment Qualification documents
- Temperature Mapping
- Water System
- Environmental Monitoring
- Risk Assessments
- Write protocols and reports
LEADERSHIP & BUDGET RESPONSIBILITIES
Provide guidance and leadership where appropriate.
SAFETY & ENVIRONMENTAL RESPONSIBILITIES
Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all of their knowledge, training, ability and experience.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Four-year college or university program certificate in chemistry, biochemistry, or related scientific field and 6 years’ experience in pharmaceutical development and/or manufacturing operations.
Ability to read, analyze, and interpret common scientific and technical journals, regulatory and compliance documents. Ability to effectively present information to management and colleagues.
Competence in scientific mathematical skills and statistics including metric analysis, trending, and reporting.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
CERTIFICATES, LICENSES, REGISTRATIONS
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.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand and sit. The employee is occasionally required to walk; work with hands; reach above shoulder height; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions, moving mechanical parts, and outside weather conditions. The noise level in the work environment is usually moderate.
These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.
- Knowledge of current Good Manufacturing Practices, ICH Guidelines and other pertinent national and international regulations.
- Excellent writing, interpretive, presentation, and interpersonal skills.
- Conflict resolution skills.
- Understanding of equipment qualification and validation.
- Good knowledge of good engineering practices and pharmaceutical manufacturing.
- Analytical skills with the ability to function with interdisciplinary teams
- Proactive approach to problem solving and resolution
This is an exempt position. Salary based upon the successful candidate’s qualifications and level of experience.
This job was first published here.