EQUAL OPPORTUNITY EMPLOYER

SUMMARY

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Collaborate, review, and approve Change Controls, Standard Operating Procedures (SOPs), and other cGMP documentation as needed
• Review and approve executed cGMP documentation to ensure compliance with internal and regulatory requirements. Resolve comments, as needed, to ensure consistency of review in the Quality organization from the Quality Associate level
• Support final product batch disposition
• Coordinate with Quality Operations for on-floor compliance and documentation support to Manufacturing as needed
• Collaborate, review, and approve minor and major investigations and Corrective Actions Preventative Actions (CAPAs)
• Create, report, and communicate product-related quality metrics to internal stakeholders
• Ensures that Quality Operations Programs comply with all compliance requirements for GMPs as defined by the QMS. Ensures that customer programs, in the execution of related quality agreements, master batch records, and the like are in accord with their requirements including regulatory files, as applicable and available
• Assist in and represent Quality during internal and external audits and regulatory inspections
• Serve as full back-up to QA Product Specialists to collaborate, review, and approve product-related Change Controls, Master Batch Records, Validation Protocols and Reports, Quality Risk Assessments, Annual Product Quality Reviews
• Provide quality input for site compliance and initiatives
• Provide updates (formal and informal) to Management and LT, as needed, regarding compliance, issues/issue resolution, and results

LEADERSHIP & BUDGET RESPONSIBILITIES

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

QUALIFICATIONS

EDUCATION and/or EXPERIENCE

LANGUAGE SKILLS

MATHEMATICAL SKILLS

REASONING ABILITY

CERTIFICATES, LICENSES, REGISTRATIONS

PHYSICAL DEMANDS

WORK ENVIRONMENT

CORE COMPETENCIES

• Excellent customer service skills
• Knowledge of cGMP, cGLP, and FDA regulations, as well as internal Quality related procedures
• Practical and theoretical knowledge of the basic principle of validation and their applications
• Ability to influence
• Excellent verbal, presentation, and written communication skills
• Ability to provide leadership in all aspects of QA processes
• Ability to function in an interactive interdisciplinary team environment
• Proactive approach to problem solving and resolution
• Broad expertise in process improvement methodology
• Demonstrated leadership skills, including coaching and mentoring, and performance management
• Routinely demonstrates a proactive approach to problem identification and resolution
• Understands Corden’s business goals and contributes technically to its strategic development
• Demonstrated ability to interact with management in developing project objectives and site strategies; advise management regarding compliance opportunities and advances
• Demonstrated communication skills (presentation, persuasion, written, oral) across all levels of the organization. Prepares clear and well-organized reports on extensive, independent work. Produces entirely self-generated presentations for audiences including upper management, and outside of the site

SALARY

Actual 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 Insurance
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• Life Insurance
• Paid Maternity/Paternity Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance