Batch Release Supervisor – Austin, Texas
Aspire…to save others’ lives, while shaping your own
Discover a new kind of career with a new kind of industry leader. Discover Hospira, the world’s leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 14,000 employees. Learn more at
Under general supervision from the MQ Manager, the Batch Release Supervisor oversees batch record review and final product disposition for products manufactured at the Austin site. Assures that each batch has been produced and tested/checked in compliance with the product specification quality requirements, batch record review, quality evaluation and routine release of products manufactured at the Austin facility.
Major Duties And Responsibilities:
Set direction for batch release auditors and supervise daily activities. Hire, train, develop and evaluate staff.
Assure that all documents received in the batch release area are logged in, assigned to an auditor for review, reviewed for completeness, determines acceptability of batch through review of batch record data, signed off and filed.
Review Batch Records and exception documents for accuracy and completeness. Suggest improvements as required.
Determine quality trends and maintain an adequate record of all batches released. This includes track and trending of control charts, maintaining Certificate of Analysis, Quality Holds, etc.
Assist other departments in the identification of potential quality issues and resolution of potential manufacturing problems. Recommend corrective actions.
Act as Management representative during the absence of the MQ Manager and during off shifts.
Perform special assessments of processes and products as required.
Participate in the budget planning process. Review the Departmental Expense detail monthly. Initiate and be responsible for cost savings projects involving both material and labor utilization.
Assist with internal, Corporate, 3
party and Federal/State audits, including FDA audits.
Actively participate in the Material Review Board (MRB), Right the First Time, Annual Product Quality Review, perform Statistical Process Control (SPC) evaluation, etc.
Bachelor’s Degree in Biology, Chemistry or Science, is required.
Certified Quality Engineer is preferred.
Two to three years prior experience in manufacturing operations, preferably in pharmaceutical, food or cosmetic industry.
Familiarity with Quality principles and practices.
Hospira - 23 months ago
Hospira helps hospitals heal the hurting. The company makes specialty injectable pharmaceuticals (primarily generics) including...