Associate II, Manufacturing

Catalent - Harmans, MD

Hiring: Associate II, Manufacturing Company: Catalent Location: Harmans, MD Job Posted Time: 2026-09-10 11:32:21 Employment Type: On-site Target Skills & Keywords : Quality Assurance About the job Required Skills: •Shift: Night shift, 7pm-7am on a 2-2-3 rotation •Complete Batch Production Records under current Good Manufacturing Practices and document processes using Standard Operating Procedures and Batch Production Records •Generate operational protocols and internal or external documents including Standard Operating Procedures, Batch Production Records, deviations, and summary reports •Partner cross-functionally with Process Development and Manufacturing Sciences and Technology teams to transfer new projects into GMP •Generate and revise internal and external documents such as Standard Operating Procedures and Batch Records •Support initiation and closure of deviations; may lead departmental investigations and close deviations and Corrective and Preventive Actions •Troubleshoot process and equipment issues; work with Facilities and Validation to maintain manufacturing equipment •Recommend equipment and supply purchases for production areas Qualifications: •Strong knowledge and ability to apply scientific principles to solve operational and routine production tasks •Excellent documentation skills including comprehension, review, and establishing Batch Production Records, Standard Operating Procedures, deviations, and summary reports •Team-oriented with the ability to collaborate effectively across Manufacturing, Quality Control, Quality Assurance, Regulatory, and Materials Management functions. •Strong written and verbal communication skills with proficiency in English. •Demonstrated capacity to work flexible schedules, including shift, overtime, and weekend coverage as required by production needs. •Capable of performing physical requirements of the role, including lifting up to 40 pounds and extended periods of standing, walking, bending, reaching, pushing, and pulling. •Demonstrated capacity to work safely and effectively in a manufacturing environment while maintaining a strong focus on quality, compliance, and operational excellence. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!