Manufacturing Process Technician

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

BASIC DUTIES:
• Operates production equipment required to package solid dose, pharmaceutical, controlled substance products in compliance with cGMPs, SOPs, FDA and DEA guidelines. 
• Responsible for all packaging support functions such as preparation of equipment and packaging components to be used in support of/or packaging of the product.
• Completes accurate and timely documentation to comply with FDA and GCP/GLP/GMP regulations.
• Uses computer systems to enter batch data, review Standards Operating Procedures (SOPs), and operate computerized packaging equipment.
• Maintains current training in assigned process area in order to support operational requirements.  As required, develop the skills needed to perform duties in other areas to support schedule fluctuations. Process areas include:  Packaging, Manufacturing granulation/blending, compression, coating, and pharmacy.
• Adheres to all regulatory guidelines including execution of supporting product documentation.
• Adheres to all safety practices and participates in safety orientations.  Provides input to Safety Team Leader and/or Committee.
• Uses knowledge of pharmaceutical processes and associated production equipment to solve production and process problems.
• Communicates with Technical Process Coordinator, Supervisor, and/or other members of management to ensure current requirements are met.
• Performs other related assignments and duties as required and assigned.
• Demonstrates and fosters teamwork, positive can-do attitude and initiative. Respects the contributions of others.  Demonstrates respect for diversity
 
QUALIFICATIONS:  HS graduate with 5+ years cGMP pharmaceutical operations experience.  Understanding of basic computer skills. -or- Associates or Bachelor degree with 2+ years cGMP pharmaceutical operations experience.
 
TECHNICAL SKILLS:  2 - 5+ years cGMP pharmaceutical operations experience.   Proficient and demonstrated experience in process areas/equipment operation in a solid-dosage manufacturing environment.  Solid dose process areas include:  Packaging, Pharmacy, Granulation/Blending, Compression, Coating and Encapsulation.

HS graduate with 5+ years cGMP packaging operations experience.  Understanding of basic computer skills. -or- Associates or Bachelor degree with 2+ years cGMP pharmaceutical packaging experience., Not Specified