API Manufacturing Associate I

Role Summary

Operate API manufacturing equipment to achieve production goals.

Responsibilities

• Work in a safe & environmentally responsible manner
• Follow instructions listed in GMP documentation & product quality
• Review SOP‚Äôs & other documents, as required
• Real-time review of electronic batch records ensuring compliance to Standard Operating Procedures (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

• High school graduate or equivalent required
• 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 preferred
• 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 required
• 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 preferred

Education

• High school graduate or equivalent required
• Associate's Degree or higher in Tech, Science, or Engineering preferred

Additional Requirements

• Physical requirements include moves of equipment &/or supplies weighing up to 33 pounds, ability to stand for up to a 12-hour shift, may require corrected vision to 20/20 or 20/25, color vision based on role, ladder use, elevated work, exposure to odorous &/or hazardous materials, latex gloves, cold environments, confined spaces, loud noise with hearing protection, and potential operation of motorized vehicles as required by the role.