SUMMARYLeads 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 RESPONSIBILITIESSupports the Quality Assurance Department in the following functions/projects. Responsible for improving the efficiency and effectiveness of all engineering related quality systems. Will have responsibility for generating or reviewing and approving the following document types. Other duties may be assigned.
- Equipment Qualification documents
- Temperature Mapping
- Water System
- Utilities
- Environmental Monitoring
- Risk Assessments
- Cleaning
- Write protocols and reports
- Annual Product Reviews
LEADERSHIP & BUDGET RESPONSIBILITIESProvide guidance and leadership where appropriate.
EDUCATION and/or EXPERIENCEFour-year college or university program certificate in Chemical Engineering, Chemistry, Biochemistry, or related scientific field and 6 years' experience in Pharmaceutical Development and/or Manufacturing Operations.
CORE COMPETENCIESThese 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
SALARYActual pay will be based on your skills and experience.
BENEFITS- 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
- Accident Plan
- Critical Illness
- Dental Insurance
- Disability Insurance
- Employee Assistance Program
- Flexible Spending Account
- Health Insurance PPO/HSA
- Hospital Indemnity Plan
- ID Theft
- Life Insurance
- Paid Parental Leave
- Tuition Reimbursement
- Wellness Program
- Vacation - Three Weeks 1st Year
- Vision Insurance
