Position Summary:

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

Work Conditions: 

• 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. 

Supervisory Responsibilities:

• None

Personnel Protective Equipment or Attire Required for Position: 

• As needed per G-016