API Manufacturing Associate I (Multiple openings)

Role Summary

API Manufacturing Associate I (Multiple openings) – 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 SOPs & 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‚Äôs 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

Skills

• Computer literacy; proficient in Microsoft Office; ability to operate computer driven manufacturing/production equipment
• Attention to detail; strong documentation and record-keeping
• Problem solving and troubleshooting based on data
• Ability to follow SOPs and safety guidelines

Education

• High school diploma or equivalent required
• Associate‚Äôs degree or higher in Tech, Science, or Engineering preferred

Additional Requirements

• Physical requirements include lifting up to 33 pounds, standing for up to 12-hour shifts, potential use of protective equipment, and ability to work in various environmental conditions as required