What are the responsibilities and job description for the MCS Manufacturing Associate-Drug Product Supply, Manufacturing position at BioPharma Consulting JAD Group?
The Manufacturing Associate will support the Drug Product Supply organization in a GMP-regulated manufacturing environment. This role focuses primarily on manual visual inspection of drug products, with potential for expanding into analytical testing based on performance. The ideal candidate will have at least one year of GMP manufacturing experience, be computer savvy, and have knowledge of SAP and Manufacturing Execution Systems (MES).
Key Responsibilities:
- Manufacturing Operations:
- Perform manufacturing tasks in accordance with Standard Operating Procedures (SOPs).
- Understand and identify process parameters and anomalies.
- Operate critical processing equipment and ensure operations are completed on schedule.
- Participate in the manual visual inspection of drug products.
- Assist in ensuring efficient operations on the manufacturing floor and communicate any issues during operations.
- Document and Process Control:
- Review, revise, and audit manufacturing documentation, including electronic batch records (EBR), SAP, and other required systems (MES, MAXIMO, LIMS).
- Escalate identified issues promptly and work toward resolving them.
- Collaboration and Support:
- Establish working relationships with cross-functional teams outside the immediate area of expertise.
- Provide support for flexible shift structures, including weekends, to meet production demands.
- Compliance and Quality:
- Adhere to GMP guidelines and interpret and apply applicable regulations.
- Apply basic principles of chemistry, biology, and physics as needed to perform manufacturing/laboratory tasks.
- Maintain a high level of attention to detail in all tasks and ensure compliance with safety and operational standards.
Skills:
- GMP Experience/Knowledge
- Problem-Solving and Critical Thinking
- Adaptability and Learning Agility
Qualifications:
- High School/GED with 2 years of work experience, OR
- Associate’s degree with 6 months of work experience, OR
- Bachelor’s degree
Preferred Qualifications:
- Experience with manual visual inspection in a GMP-regulated environment.
- Background in analytical testing or laboratory settings.
- Familiarity with PAS-X Werum software for electronic batch records, with basic knowledge of editing and validation.
- Strong understanding of drug product operations and bioprocessing.
Shift:
- Current shift structure: 6:00 AM – 3:00 PM
- Some training may require a 5:00 AM start time.
- Flexibility to move to graveyard/swing shifts as needed.
