Job Information
LSNE - MADISON, LLC Manager Quality Control in MADISON, Wisconsin
JOB REQUIREMENTS: Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. This position is responsible for the daily QC oversight of PCI\'s laboratory functions. This includes all operational and technical activities in delivering quality chemical, biopharmaceutical and microbiologic testing services to our customers. This position oversees core activities such as in process testing and micro testing. The role includes oversight of raw material, in process, and reviewing release testing of GMP products to support our clients, interacting with Clients concerning project specific QC issues, approving department cGMP documents, contributing to cGMP reports, and managing QC staff as necessary to achieve these tasks. . ESSENTIAL DUTIES AND RESPONSIBILITIES: Provides Quality Control oversight of all cGMP testing of raw materials, in process, product release, clean utility and environmental monitoring testing. Review and approve all QC related investigations (deviations, OOS/OOT, EM Investigations, etc.) both with internal and external laboratories Maintains good relations and communications with clients as a primary technical interface Interact with customers to identify opportunities to improve quality and establish feedback with manufacturing personnel Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented Working with project teams to represent Quality Control, conducting risk assessments and introducing best practices into the Quality Control processes Leading customer interaction on all QC related projects including routine testing updates Manage and develop professional and technical skills and performance of department members Assure all QC functions and testing are being performed according to FDA, EMA, ICH and other international regulations, as deemed necessary Supporting regulatory information requests from customers as it pertains to QC. Supporting Operations, Project Management Staff and Quality Assurance as needed Drive technical troubleshooting, operational improvements, and efficiency improvements while working within cGMP and global regulatory compliance Demonstrate substantial... For full info follow application link. LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company\'s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/9F2E79B47F3F462D