Manufacturing Associate

Responsibilities

• Execute work instructions and apply job skills to complete assignments.
• Achieve full training status and assist in training staff.
• Work on semi-routine assignments, receiving instruction on new processes.
• Maintain inventory records and accurate batch records.
• Inspect finished products for adherence to specifications.
• Assist with batch record reconciliation and preventative maintenance tasks.
• Adhere to Quality Management Systems and assist with Nonconformance/CAPA closures.
• Identify and communicate items requiring escalation.
• Maintain a clean and safe work environment.
• Follow company policies including safety, training, GDP, and cleanroom gowning.
• Spend 90% of time in manufacturing suites.

Required Skills

• High school diploma or equivalent required.
• Minimum of 1 year of experience in manufacturing, operations, production, laboratory, or a related environment.
• Previous experience working in a cGMP environment preferred.
• Technical knowledge of biopharmaceutical manufacturing equipment, processes, and principles.
• Strong understanding of current GMP and workplace safety standards.
• Ability to perform moderately complex GMP manufacturing activities with minimal to moderate supervision.
• Ability to recognize situations requiring further evaluation and appropriately escalate issues to senior operators or management.
• Ability to interpret, complete, and review operational documentation accurately and in compliance with GMP requirements.
• Ability to work effectively in a dynamic environment and manage multiple priorities.
• Strong written and verbal communication skills with peers, senior associates, and area management.
• Ability to learn and effectively use new software, systems, and tools.
• Ability to perform aseptic and/or sterile gowning as required.
• Ability to safely perform assigned activities while following procedures designed to prevent product releases, accidents, and injuries.
• Ability to wear required personal protective equipment (PPE) and closed-toe shoes.
• Ability to work with or around dry ice, liquid nitrogen/cryogenic materials, hazardous materials, and infectious agents, as required.
• Ability to work in environments with significant temperature variations.
• Ability to read, write, and review documentation and perform computer-based tasks for extended periods.
• Ability to regularly sit, stand, talk, and hear for extended periods and occasionally walk, reach, stoop, kneel, or crouch.
• Ability to meet visual requirements including close, distance, color, peripheral vision, depth perception, and the ability to adjust focus.
• Must comply with applicable GMP, safety, hygiene, personal appearance, and site-specific requirements, including restrictions on piercings and nail polish where applicable.