Manager, Quality Assurance (Hybrid)

Company: Sharp Services, LLC
Location: Bethlehem
Posted on: August 8, 2022

Job Description:

Summary Responsible for providing oversight of Quality Assurance Specialists and batch record reviewers to assure compliance with internal procedures and regulatory requirements.Provides Quality Assurance supervisory oversight of assigned QA functions and areas of manufacturing to ensure drug products are processed in accordance with cGMPs and other applicable regulatory requirements for drug products and medical devices. Responsible to assess, investigate and effectively resolve processing issues in conjunction with subject matter experts, and in accordance with standard operating procedures.Responsible for contact with QA representative's internal and external customers regarding quality issues related to manufacturing/packaging and resolution of issues.Essential Duties and Responsibilities Provide leadership and direction for the QA Specialists and Batch Record ReviewersOversee the key quality processes that impact/relate to product compliance including batch record review and product release, compliance in movement and storage of materials, Investigations, and CAPAs as related to product complianceResponsible for assuring all customer complaints, and product related Investigations/CARs are completed in a timely mannerProvide oversight to the master batch record issuance and batch release processes for Manufacturing and PackagingTroubleshoot and direct the resolution of Quality issues related to Packaging and Manufacturing by fostering effective interdepartmental and cross-functional partnershipsEnsures products (including services) are developed, manufactured, tested and delivered according to established procedures that will assure that they meet all quality requirements.Lead process improvement initiatives related to Quality Assurance.Provide input to the development of personal performance goals and departmental objectivesCollaborate with Management to establish and meet targets and timelines for the Quality DepartmentApply advanced theory, technical principles, and expert judgment to address a broad range of issues affecting product complianceServe as a technical subject matter expert (SME) in support of department functionsManage competing priorities and provide adequate support to QA staff as requiredQualificationsTo 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. Bachelor's Degree in a science or Technical fieldA minimum of 5 years' experience in a regulated pharmaceutical or biopharmaceutical industryLeadership experience in a QA, laboratory or production environment required, including a demonstrated ability to identify problems, and initiate successful corrective actions.Quality Assurance experience in an operational or development setting with demonstrated knowledge of techniques for assessing the quality of processes and the ability to guide others in these activities.Advanced knowledge of GMPs, ISO and other applicable regulatory requirements for pharmaceuticals and medical devices and the ability to communicate this knowledge to the entire organization professionally and succinctlySuperior verbal and written communication skillsExperience with Microsoft Office applications and ERP systemsHas adequate emotional intelligence to handle a variety of situations professionally and in accordance with regulatory compliance

Keywords: Sharp Services, LLC, Atlanta , Manager, Quality Assurance (Hybrid), Executive , Bethlehem, Georgia