QA Product Specialist

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. Corden Pharma embraces fair hiring practices.

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.

Include the following. Other duties may be assigned.

• 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
• Provide Quality leadership and decision-making on cross-functional teams that include but are not limited to Operations, Process Engineering, Quality Control, and Safety
• Perform final product batch disposition
• Assist in and represent Quality during internal and external audits and regulatory inspections
• Perform other duties as needed to support Corden Pharma initiatives and improvements

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.

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.

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.

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.

Ability to read, analyze, and interpret common scientific and analytical journals. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to communicate information to customers and senior management. Ability to effectively present information to top management and public groups.

Ability 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.