Manufacturing Technician
6 days ago
Santa Ana
Job Description Globally recognized leader in Assisted Reproductive Technology (ART) is looking to hire 5 individuals for a Manufacturing Technician role with 1st and 2nd shifts available. This is a hands-on manufacturing role in a controlled cGMP environment. The role requires strong attention to detail, reliable attendance, and the ability to follow written procedures, batch documentation, and site-specific GMP requirements. This assignment is temporary, with duration based on business and production needs. There may be potential for extension or conversion to a longer-term role based on performance, business need, and organizational approval. The Manufacturing Technician will: • Perform manual kit assembly, packaging, sealing, and labeling activities in accordance with approved procedures and batch documentation., • Inspect components, labels, containers, and finished kits for accuracy, completeness, appearance, and proper configuration., • Verify product identity, quantity, labeling, lot information, and packaging configuration against applicable work instructions and production records., • Prepare, assemble, and package finished product kits using defined process steps and controlled materials., • Operate basic production and packaging equipment such as labelers, sealers, shrink-wrap equipment, torque tools, scanners, scales, or other equipment as required., • Complete production records, logbooks, forms, and electronic transactions accurately, legibly, and contemporaneously., • Perform material staging, component reconciliation, and inventory-related transactions to support batch accountability., • Follow line clearance, segregation, and product status control requirements to prevent mix-ups and maintain GMP compliance., • Identify and escalate discrepancies, damaged materials, documentation errors, equipment issues, or process concerns to supervision., • Maintain cleanliness, organization, and GMP readiness of the work area., • Follow applicable SOPs, batch records, work instructions, safety requirements, and site procedures., • Support product movement, material handling, and controlled storage activities as needed., • Assist with preparation of production supplies, labware, or supporting materials as assigned., • Participate in training, gowning, and site-specific onboarding requirements., • Support other manufacturing, packaging, inspection, or kitting activities as directed by supervision., • Perform all other ad-hoc duties as required and / or requested by Manager. Requirements: • High school diploma, GED, or equivalent., • Prior experience in GMP, medical device, pharmaceutical, biotechnology, diagnostics, food, or other regulated manufacturing environment., • Experience with packaging, kitting, labeling, inspection, assembly, or production documentation., • Familiarity with Good Manufacturing Practices, Good Documentation Practices, line clearance, material reconciliation, or batch record execution., • Experience using electronic documentation, ERP, inventory, or production tracking systems., • Basic understanding of metric units and material/component traceability., • Ability to read, understand, and follow written procedures, batch records, and work instructions., • Strong attention to detail and ability to perform repetitive manual tasks accurately., • Ability to speak, read, and write sufficiently to complete GMP documentation and follow safety instructions., • Basic math skills, including ability to count, reconcile quantities, and understanding units of measure., • Ability to work in a controlled manufacturing, laboratory, warehouse, or cleanroom-adjacent environment., • Ability to sit, stand, walk, reach, bend, and perform hands-on assembly or packaging tasks for extended periods., • Reliable transportation and ability to travel between nearby work locations within approximately a 5-mile radius., • Ability to work overtime, weekends, or adjusted shifts based on production needs., • Work may be performed in controlled manufacturing or CDMO production environments., • Requires gowning, PPE, hair covering, gloves, safety glasses, or other site-specific protective equipment., • Must be able to perform repetitive manual operations with a high degree of accuracy., • Must be able to lift, move, or handle production materials within site-defined safety limits.