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Manufacturing Tech - Coating
Ref No.: 18-00022
Location: Durham, North Carolina
Manufacturing Technician - Coating
• Project Work is Supporting: manufacturing
• Education Level: High School Graduate/GED

• Assignment Description:


Position will provide support to the solid dosage manufacturing coating operation and other process areas as required.

HS graduate with 5+ years cGMP pharmaceutical coating operations experience. Understanding of basic computer skills.


Associates or Bachelor degree with 2+ years cGMP pharmaceutical coating operations experience.

• Summary of Work:

Incumbent will be responsible for all aspects in solid dosage manufacturing of product to ensure compliance with cGMPs, SOPS, FDA, and DEA guidelines.


o Operates production equipment required to manufacture solid dose pharmaceutical controlled substance products in compliance with cGMPs, SOPs, FDA and DEA guidelines.

o Responsible for all manufacturing support functions such as preparation of equipment and manufacturing components to be used in support of/or manufacturing of the product.
o Completes accurate and timely documentation to comply with FDA and GCP/GLP/GMP regulations.

o Performs calculations, critical measurements and weights for production needs as stated in the Manufacturing Batch Record.

o Uses computer systems to enter batch data, review Standards Operating Procedures (SOPs), and operate computerized manufacturing equipment.

o Maintains current training in manufacturing process areas in order to support operational requirements. As required, develop the skills needed to perform duties in other areas to support schedule fluctuations.

o Adheres to all regulatory guidelines including execution of supporting product documentation.

o Adheres to all safety practices and participates in safety orientations. Provides input to Safety Team Leader and/or Committee.

o Uses knowledge of pharmaceutical processes and associated production equipment to solve production and process problems.

o Communicates with Technical Process Coordinator, Supervisor, and/or Senior Supervisor to ensure current requirements are met.

o Performs other related assignments and duties as required and assigned.