The QA Specialist Product Complaints is responsible for ensuring compliance of the Product Quality Complaint (PQC) process as well as participating in additional aspects of the post market surveillance program. This role will initiate incoming Product Complaints, lead and/or facilitate investigations both at client and at Contract Manufacturing Organizations (CMOs), and w

Develop test methods for Design V&V, Process Validation, and Production Validate test methods Execute Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work Author/release new test methods and edit/redline old test methods Perform tasks assigned that are related to Test Engineering that may be outside the scope of this specific projec

Collaborate internally and with vendors to evaluate, select, and validate cost effective primary, secondary, and tertiary packaging materials, equipment, and machines that meet industry standards for sterile barrier packaging systems and other packaging systems Support cost reduction, process efficiency, and/or quality improvements through standardization, automation, and

Ensure compliance with multiple assigned trials and successfully conduct all protocols in accordance with FDA, GCP/ICH guidelines, and research SOPs Coordinate the implementation and conduct of research requirements by submitting documents for sponsor and IRB approval, maintenance of regulatory documents, and communication of changes to the research team Maintain a good w

Provide engineering support to manufacturing and resolve issues related to process validations Design, build, or procure improved fixtures, tooling, or equipment to increase quality, reliability, capacity, and yield Supply floor layouts for areas associated with manufacturing operations Write test protocols, preform tests to fully characterize new equipment or processes u

Lead study start up/study conduct activities, approve study specific essential documents list, and manage/communicate the status of study progress/activities Partner with cross functional teams for query management, data reviews, and resolutions Provide coaching and training to junior employees Investigate all discrepancies in study documentation and apply clinical protoc

Develop a strong documentation package, from conceptual study to various phases of qualification like IQ, OQ, DOE trials Perform Qualification of equipment, facilities, and utilities Complete projects within set timelines to meet the company objectives Lead qualification and documentation related to validation department Forecast workload and ensure effective work process

Prepare and assist with preparation of key documents such as Investigator Brochures, regulatory submission documents, internal and external presentations, and publications Manage synopses, protocols, and Informed Consent Forms including writing, reviewing, amending, and cross functional facilitation Participate in clinical development plans for assigned compounds Review c

Contribute to clinical pharmacology plans and strategies to meet corporate, scientific, and regulatory needs as a member of appropriate program teams Support the pharmacokinetic and pharmacodynamic aspects of clinical studies Collaborate with other functions in the analysis, design, and interpretation of Phase 1 4 clinical studies Develop translational strategies to recom

Contribute and author documents for IND/NDA/CTA and other regulatory documents Provide scientific and technical leadership for successful study related documents and correspondence Ensure each decision affecting study outputs are fully documented in accordance with relevant SOP's and are in compliance with regulatory review Assist in writing and reviewing protocol, synops

Build and maintain a good business relationship with functional departments Provide quality service/oversight on pertinent GMP functions Review and approve validation documentation and lifecycle documentation Follow SOPs to perform routine activities (periodic review, Data Integrity audit, inventory log maintenance, etc.) and complete related quality documents Assist with

Manage the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas Supervise the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives Ensure quality of data submitted from study sites and timely submission of data including appropriate reporting and foll

Collaborate with Medical Affairs colleagues and external vendors to execute asset strategy and tactical plans with appropriate use of resources according to developed timelines Track priority Medical Affairs tactics and performance to goals/budget Provide high quality scientific/clinical input and review of medical content of promotional and medical materials for accuracy

Work to ensure the roll out, on going compliance of quality systems, and associated procedures/standards are completed Manage compliance risk assessments and facilitate root cause analysis, CAPA implementation, and effectiveness checks Develop, implement, and execute the audit strategy and Inspection Readiness plans for Clinical/PV programs Execute risk based audit progra

Negotiate initial or amended site CTAs/budgets, and serves as escalation point and oversight for CROs negotiating site CTAs Budget on the company's behalf in support of assigned global Clinical Studies Negotiate other initial or amended clinical Agreements such as IIRs, CDAs, Consulting Agreements, and Vendor Agreements such as MSAs, SOWs, and COs Ensure appropriate Data