QA Engineer

Summary

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.
• 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:
• Equipment Qualification documents
• Temperature Mapping
• Water System
• Utilities
• Environmental Monitoring
• Risk Assessments
• Cleaning

LEADERSHIP & BUDGET RESPONSIBILITIES

• Provide guidance and leadership where appropriate.

Safety & Environmental Responsibilities

• Safety & Environmental Responsibilities: Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace.

Qualifications

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed below are representative of the knowledge, skill, and/or ability required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Educational and Experience Requirements: Four-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.

Reasoning Abilities

• 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.

Education and Certifications

• No certificates or licenses required.

Physical Demands

• 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.

Core Competencies

• 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.
• A proactive approach to problem solving and resolution.

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

Equal Opportunity Employer

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.