Job Information
BIOTECHNIQUE LLC QA Manager 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. The QA Manager is responsible for oversight of all daily functions of the quality system. Directly Supervise Documentation Control, QA Associates and Trainer, and act as backup and support to their activities. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Work directly with the Sr. Director, Quality on continuous improvement activities. Responsible for ensuring that client specifications are met during materials receipt, Drug / Device processing and final product shipment. Responsible for ensuring that procedures are followed and quality standards are met. Works directly with the Sr VP of Quality to evaluate products and materials for compliance to specifications. Oversight for established quality systems (Document Control, CAPA, Deviation, Environmental Monitoring, Change Control, Complaint, Calibration, Documentation, Training, Component Control, Batch Record Review, Label Control, Product Release). Review/approval of Validation Protocols (master and final reports). Approval of Deviations and CAPAs. Responsible for Environmental Monitoring and WaterTrend Reports. Provide QA Staff support (and backup) including: Scheduling updates and assignment of duties. Documentation Control prioritization: document processing, batch record issuance, change control issuance. Training: issuing notifications for training needs, maintenance of training files, initiating core training for new employees, present training to personnel as needed. Operations: provide line clearances and documentation as needed. Product and Materials Records Review: batch record review and release, materials review and approval, including - calibration, water testing, environmental monitoring, temperature and humidity review. Work Environment: Work is primarily performed at a desk and/or in an office environment. for 1/2 to 3/4 of the day. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required... 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/A098BA3EEAAF454B