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Senior Quality Specialist – Merck DP, West Point, PA

Mindlance

This is a Full-time position in North Wales, PA posted April 7, 2021.

Job DescriptionClient s currently seeking a Senior Quality Specialist for a long-term engagement with one of our Global Pharmaceutical clients.This person will join our FSP (Functional Service Provider) division, a managed solution provider.

This role is full-time and is offering full benefit options.

As a  FSP employee you may be eligible for Medical, Dental, Vision, 401K, and a variety of other benefits to choose from.

You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.RESPONSIBILITIES:Support the effective and compliant execution of tech transfer activities and development of necessary quality systems at the EM sites and associated off-site storage locations.Support site qualification activities and development of quality agreements in accordance with Company standards.Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch records to ensure Company products/processes comply with cGMP requirements.Support regulatory submission activities, and lead inspection readiness activities in partnership to support global health authority approvals.Following successful tech transfer, support quality oversight for day-to-day production activities, including deviation and CPA management, escalation of critical issues, and change control.Monitor quality performance and proactively identify risks and mitigation plans through benchmarking and knowledge sharing.Influence and build relationship with internal and external partners to continuously enhance quality culture and business excellence.Interface with other functions (Operations, Planning, Technical Operations, Local Affiliates etc) to meet patient supply requirementsApply cGMP regulations and other FDA and international requirements to all aspects of the position.QUALIFICATIONS:Minimum education required for competent performance:Bachelors Degree with a concentration in engineering, science, or an equivalent technical disciplineAdvanced degrees are a plus and may reduce the experience requiredMinimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:Minimum of 8 years working in an FDA regulated environmentEquipment usage and abilities needed:Experience in pharmaceutical aseptic manufacturing operations and quality assuranceDetailed knowledge of cGMPs related to pharmaceutical productionStrong interpersonal and written/oral communication skillsAbility to quickly process complex information and make critical decisions with limited information requiredExperience in Vaccine Production/ QAProficient in applying process excellence tools and methodologiesExperience working with External Manufacturers or LabsPrevious experience with a CMOIdeal candidate will have a blend of QA, QC and Validation experience (QA and Validation are the most critical)”Location:Must be local to West Point, PAUP TO 80% time to be on site at External Manufacturer possible.