Fort Washington, PA - Validation Scientist II

Job Description:

• Ensure that effective quality systems are designed, operating effectively and constantly improved upon to meet the needs of the McNeil Nutritional’s businesses
• Product safety and quality risk assessments at product design stage of project
• Internal development of QA sampling and testing requirements
• Ensuring that product specifications are appropriate for the product and that the manufacturing processes can deliver product to specification
• Technical assessment of analytical test data to support QA investigations, process improvements and risk abatement
• Audit and approval of Third Party Manufacturing Sites, Warehouses, and Suppliers
• Audit and approval of Third Party Laboratories

Responsibilities:

• Actively participates on new product launch teams and ensures that quality and food/product safety risks are identified and that mitigation plans are developed during the design phase of the project
• Assesses qualification activities for feasibility and soundness using a quality assurance lens
• Reviews and approves product and process specifications, raw material and packaging specifications, test methods, protocols and completion reports, and change control documents
• Conducts supplier and external manufacturing assessments and reports, tracks and follows up on deficiencies noted
• Leads root cause analysis, material review and resolution of non-conformance issues and adverse quality trends
• Utilizes and promotes the use of statistical / analytical tools to drive compliance and quality improvement initiatives
• Develops processes and procedures and delivers training in quality related subjects to the QA division, partner functions, and third party manufacturing sites
• Coaches cross-functional partners in Quality requirements and processes

REQUIREMENTS:

• Bachelor of Science degree in Food Science, Biology, Microbiology, Chemistry, or other life science (Master’s degree preferred)
• Ten years of experience within a quality assurance related function in the food / dietary supplement / pharmaceutical industry (At least half of this experience should be within a manufacturing environment)
• Must have experience with product design and new product launches
• Demonstrated expertise in Food Safety, Microbiology, Analytical Techniques for food and supplement products, Good Laboratory Practices and broad knowledge of analytical testing methods for foods and dietary supplements
• Working knowledge of qualification / validation processes used to launch new food and dietary supplement products
• Strong working knowledge of Quality Systems including, cGMP, HACCP, Sanitation Practices, Statistical Process Control, Corrective /Preventative Action Plans and government regulations
• Ability to effectively assess programs containing these elements at suppliers, contract manufacturers, and service providers
• Keen deductive reasoning and problem solving skills
• Strong interpersonal skills and ability to work effectively in a team environment
• Must be able to influence and build consensus of others within the division or within other functions
• Ability to manage multiple tasks concurrently
• Effective verbal/written communication skills, including the ability to write technical reports and develop and deliver effective presentations to all levels of the organization
• Ability to skillfully balance business and compliance risk

Desired or Preferred Knowledge, Skills, and/or Abilities:

• Experience working with contract manufacturers preferred
• Knowledge of Design Excellence principles desired
• Product development experience desired

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