QA Product Specialist

About the role

Provides Quality Assurance related product leadership as it relates to planning and execution of products. Responsible for the collaboration, review, and approval of GMP documents. Represents a high-level of GMP understanding and accomplishment. Responsible for providing strong Quality leadership and scientific/GMP information support as the Quality representative supporting the lifecycle of products for internal and external customers.

Responsibilities

• Represent QA for all Quality related customer interactions for one or more products.
• Responsible for clear, direct, and appropriate communication in customer interactions.
• Provide process support including process validation, technical transfer, and commercial activities. May include clinical development as needed.
• Collaborate, review, and approve product-related Change Controls, Master Batch Records, Validation Protocols and Reports, Quality Risk Assessments, Annual Product Quality Reviews, and other cGMP documentation.
• Collaborate, review, and approve minor and major investigations and Corrective Actions Preventative Actions (CAPAs).
• Create, report, and communicate product-related quality metrics to internal and external stakeholders.
• Assure that manufacturing processes, packaging, and testing comply with all regulatory filings and Corden SOPs to ensure favorable quality inspections and customer satisfaction.
• Perform final product batch disposition.
• Assist in and represent Quality during internal and external audits and regulatory inspections.

Qualifications

• Bachelor’s Degree in Science and 5 years of Quality Assurance experience within the Pharmaceutical Industry; or a combination of Pharmaceutical Industry within a Technical/Operations role and academic experience.
• Project Management experience, although not required, is beneficial to this position.
• Reasoning ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
• Mathematical skills to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

Leadership & Budget Responsibilities

Responsible for providing Quality leadership throughout the lifecycle of a product. Supports training for QA Associates and other quality personnel. Carries out leadership responsibilities in accordance with Corden policies and applicable laws.

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 their knowledge, training, ability, and experience.

Education & Experience

• Bachelor’s Degree in Science and 5 years of Quality Assurance experience within the Pharmaceutical Industry; or a combination of Pharmaceutical Industry within a Technical/Operations role and academic experience.
• Project Management experience, although not required, is beneficial to this position.

Reasoning Abilities

• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

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.
• Analytical ability and ability to influence.
• Knowledgeable in analytical skills with the ability to function in an interactive interdisciplinary team environment.
• 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 Insurance
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• 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.