The QA Manufacturing Coordinator has primary responsibility for handling all front office operations as outlined below.
Responsibilities: Including but not limited to:
• Maintain communication with QA Validation and PM Department to ensure that all requirements for validated products, with respect to manufacturing operations, are accurate, current, and complete.
• Ensure that the Job request list, conveys accurate and on-time issuance of production and non-commercial batches.
• Ensure Administrative Assistant work regarding batch issuance and all special instructions have been met.
• Request issuance of batches with related labels (bulk and IP). Updating production board accordingly.
• Perform check of all issued batches.
• Coordinate with Admin, IP batch folders for deduction, posting and filing for various stages.
• Coordinate Change Control and action item tasks.
• Track change controls and deviations that affect manufacturing particularly those that affect MMR’s and batch records.
• Coordination of DEV for Operations Compliance.
• Create and route bulk labels for approval as needed. Coordinate the bulk label process including creation, customer approval and maintenance.
• Update forms, as necessary.
• Request SOP for an action item update.
• Vendor correspondence/sign off
• Other responsibilities as assigned by Senior Management.
Education and Experience:
• Associate degree required
• Bachelor’s degree preferred
• One-year related work experience in quality assurance preferred
Skills and Abilities:
• Excellent oral and written communications skills, working knowledge of MS Office
• Ability to prioritize and multitask
• Motivated and detail-oriented, with exceptional organizational skills
• Hours/Travel maybe subject to changed based on management/company discretion.
• While performing the duties of this job, the employee is regularly required to sit, stand or walk for long periods. The employee may lift and/or move up to 23 kg. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus.
Personnel Protective Equipment or Attire Required for Position:
• As needed per G-016