What are the responsibilities and job description for the MCS Manufacturing Associate-Purification position at BioPharma Consulting JAD Group?
The MCS Manufacturing Associate in Purification will support development, clinical, and launch activities within the Drug Substance plant. This role is crucial for ensuring the efficient execution of manufacturing processes, with a focus on large-scale purification processes like chromatography, filtration, and pressurized equipment. The ideal candidate must be a highly adaptable team player, committed to working in a structured, fast-paced environment while adhering to GMP standards. Shift flexibility is required, including weekend and holiday work. The role offers the opportunity for growth and development in a dynamic, high-compliance production environment.
Key Responsibilities:
- Perform testing of critical samples while complying with GMPs to ensure continuous processing.
- Maintain analytical equipment, perform basic troubleshooting, and adhere to defined manufacturing procedures (MPs) and standard operating procedures (SOPs).
- Initiate and own quality records and documentation (SOPs, MPs).
- Assist in reviewing and updating documentation for assigned functions, such as equipment logs and batch records.
- Identify, recommend, and implement improvements related to routine functions to enhance efficiency.
- Report problems accurately and recognize potential issues in real-time.
- Maintain an organized and clean workspace, ensuring compliance with safety and GMP regulations.
- Work with high-pressure systems and heavy equipment as required.
- Collaborate with team members to complete operational tasks and contribute to a positive work environment.
- Work in a cleanroom environment while adhering to gowning procedures (steel toe shoes, full clean room gowning, hairnet, gloves).
Physical Requirements:
- Ability to regularly lift up to 35lbs and push/pull objects requiring up to 50lbs of force.
- Stand, bend, reach, squat, kneel, and perform other physical tasks in a manufacturing environment.
- Ability to work on your feet for long durations and perform physical movements such as climbing and working on portable stairs or ladders up to 6 feet.
- Ability to work under rigorous, repetitive tasks.
Preferred Skills:
- Motivated to train on new tasks and perform basic troubleshooting.
- Ability to work in a fast-paced environment while complying with GMP standards.
- Strong team player with the ability to maintain a positive work environment.
- Excellent organizational skills with attention to detail and adherence to GMP documentation.
- Flexibility to work various shifts, including day, swing, graveyard shifts, weekends, and holidays.
Qualifications:
- High School/GED with 2 years of work experience, OR
- Associate’s degree with 6 months of work experience,
- OR Bachelor’s degree.
Shift:
- Primary Shift: 7:00 AM – 6:00 PM
- Potential Future Shifts: 7:00 AM – 8:00 PM or 7:00 PM – 8:00 AM (including flexibility for holiday work)
- Rotation: May require adjustments based on manufacturing needs.
- Duration: 3-month contract with potential for extensions.
