API Manufacturing Associate I (Multiple openings)

Role Summary

Operate API manufacturing equipment to achieve production goals at the Clayton, NC facility. Work in a highly automated environment following GMP/cGMP standards, review batch records and SOPs, and participate in qualification and validation activities. Assist in maintenance and troubleshooting as needed.

Responsibilities

• Work in a safe & environmentally responsible manner
• Follow instructions listed in GMP documentation & product quality
• Review SOPs & other documents, as required
• Real time review of electronic batch records ensuring compliance to SOPs & current Good Manufacturing Practices (cGMP) standards
• Manage individual training plan
• Participate in qualification & validation activities as required
• Setup, operate, monitor, & control highly automated processes & systems
• Load & unload product from trucks, tankers & ISO containers, as required
• Execute production schedule to achieve production goals
• Utilize investigation skills during troubleshooting & assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance
• Maintain clean room areas & perform environmental monitoring, as required
• Other accountabilities, as assigned

Qualifications

• Required: High school graduate or equivalent
• Preferred: Associate’s degree or higher in Tech, Science, or Engineering
• Preferred: BioWork or equivalent industrial, military or vocational training combined with experience
• Preferred: Minimum two (2) years of manufacturing experience in FDA regulated environment
• Preferred: Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & facts. Actively participated in & driven event response activities. Documented problems & worked on ensuring rapid resolution & preventing recurrence
• Preferred: Experience following SOPs to perform tasks & raising issues if errors are found
• Preferred: Experience following established safety guidelines when performing tasks
• Required: Computer literacy including, but not limited to, ability to operate computer driven manufacturing/production equipment & efficient use of Microsoft Office suite programs
• Required: Ability to read & understand complicated product documentation & standard operating procedures with attention to detail
• Required: Ability to perform basic material handling tasks, safely & effectively use material handling equipment
• Required: Ensure compliance with corporate/local SOPs, regulations & ISO standards
• Required: General knowledge in cGMP manufacturing & production processes associated with pharmaceutical companies
• Preferred: Basic knowledge of biology/ chemistry
• Preferred: Mechanical aptitude, ability to follow use tools to perform tasks, basic troubleshooting of mechanical components & systems
• Preferred: Experience working with work permits/ Lock Out Tag Out systems

Additional Requirements

• Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions
• Routinely operates & inspects manufacturing equipment using hands
• Strap & unstrap pallets using hands
• Must be able to be on your feet for up to a 12-hour shift
• May require corrected vision to 20/20 or 20/25 based on role
• May require color vision based on role
• Occasionally ascends/descends a ladder; may be required to work at elevated heights
• Occasionally works around odorous &/or hazardous materials
• May be required to wear latex gloves
• May perform critical job functions in extremely cold work environments depending on site
• May position oneself within confined spaces for inspection if required of the role
• Ability to work in loud noise environments with hearing protection
• May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role