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The Manufacturing Technician I is accountable for results in a fast-paced environment and assists with the manufacturing of drug products (parenteral or solid dosage) for commercial distribution and clinical trials. The Manufacturing Technician I assists with the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Technician I employ acceptable techniques while working in manufacturing environments, including PPE gowning. The Manufacturing Technician I works collaboratively to support other manufacturing areas as required.
Job Responsibility
Follows applicable SOPs and cGMPs to perform assigned duties and tasks
Ensures timely completion and compliance with cGMP and all other relevant company training requirements
Assists with applicable manufacturing techniques and technologies per SOPs and cGMPs
Assists with manufacturing technologies and operation of manufacturing and material handling equipment
Documents activities in real time on controlled documentation and legibly, per SOPs and cGMPs
Performs in-process testing, weight checks, component counting and basic math calculations
Performs cleaning of rooms, tools and equipment
Assists with other manufacturing areas as required
Requirements
High school diploma or GED required
1+ years of GMP and prior pharmaceutical work experience required or BioWork certification from an accredited institution
Nice to have
Associate’s degree preferred
Awareness of or prior experience with cGMP practices and procedures preferred