The Manufacturing Operations Associate is responsible for aseptic manufacturing and assembly of clinical and commercial human blood derived components in a clean-room environment (Class 10,000/ISO7, and Class 100,000/ISO8).
Weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities.
Maintains records to comply with regulatory requirements and acts as subject matter expert for revisions or improvements to manufacturing documents.
Works with other Cell Processing Associates utilizing good manufacturing practices during aseptic processing of clinical and commercial products using Standard Operating Procedures.
Represents department in cross-functional teams, projects and GXP-related problem resolution.
Posts weights and shipping charges, and prepares goods for final shipment.
Prepares and maintains records of merchandise shipped.
Prepares goods for final shipment and unpacks and checks goods received against purchase orders and invoices, maintains records of received goods, rejecting unsatisfactory items if necessary.
Examines, stocks, and distributes GMP and non-GMP materials to inventory and manufacturing lines.
Other duties as assigned
Applies job skills and company policies and procedures to complete a wide range of tasks.
Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.
Normally receives general instructions on routine work, detailed instructions on new assignments.
Uses ability as a skilled specialist in accordance with company policies and procedures to compete complex tasks in creative and effective ways.
Works on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making routine recommendations.
May determine methods and procedures on new assignments and may provide guidance to other support personnel.
Ability to work 12 hours shifts.
Ability to be flexible and support all functions by readily responding to changing circumstances (i.e.shift changes) and business needs.
Associate’s or Medical Technical degree or equivalent.
Typically 2 years related experience in CGMP/FDA regulated industry or 1 year with Medical Technical degree.