Manufacturing Associate - Buffer Preparation

Job Description

Job Description

Manufacturing Associate – Buffer Preparation

Night Shift | Mid-Scale Manufacturing

Position Summary

We are seeking a Manufacturing Associate to support floor operations within the Mid-Scale Buffer Preparation area . This is a hands-on manufacturing position primarily responsible for supporting buffer preparation activities, working with concentrates and P11 , and completing associated production documentation.

Candidates must understand and be fully committed to the required 12-hour overnight rotating schedule .

Required Night-Shift Schedule

Hours: 6:30 p.m.–6:30 a.m. (1830–0630)

The schedule alternates every week:

• Week 1: Monday, Tuesday, Friday, Saturday, and Sunday
• Week 2: Wednesday and Thursday
• The two-week rotation then repeats.

This position requires working overnight shifts, alternating weekends, and applicable holidays based on the assigned manufacturing schedule. Candidates should confirm they can reliably work the complete schedule before applying.

Key Responsibilities

• Perform floor-based manufacturing activities primarily within the Mid-Scale Buffer Prep area .
• Prepare, handle, and support the use of buffers and concentrates according to approved procedures.
• Work with P11 processes, equipment, or materials as required.
• Follow approved batch records, SOPs, work instructions, and manufacturing procedures.
• Accurately document activities in batch records and other controlled records.
• Perform material staging, weighing, measuring, mixing, transfer, and related buffer-preparation activities.
• Operate and monitor assigned manufacturing equipment.
• Complete required equipment setup, cleaning, sanitization, and changeover activities.
• Maintain accurate material identification, labeling, and traceability.
• Follow cGMP, safety, environmental, and contamination-control requirements.
• Identify and promptly report equipment issues, process discrepancies, deviations, or safety concerns.
• Coordinate with Manufacturing, Quality, Warehouse, and other supporting departments.
• Maintain a clean, safe, organized, and inspection-ready work area.
• Support additional manufacturing activities as operational needs require.

Qualifications

• High school diploma or GED required; associate’s or bachelor’s degree in a scientific or technical field is preferred.
• Previous experience in pharmaceutical, biotechnology, food, chemical, or other regulated manufacturing is preferred.
• Buffer preparation, solution preparation, compounding, or manufacturing-floor experience is highly desirable.
• Familiarity with cGMP procedures and controlled documentation is preferred.
• Ability to follow detailed written instructions and accurately complete manufacturing records.
• Strong attention to detail and commitment to safety and product quality.
• Ability to communicate effectively and work collaboratively in a team environment.
• Ability to work independently during overnight operations.
• Reliable attendance and punctuality are essential.

Physical and Work Requirements

• Ability to work on the manufacturing floor for extended periods.
• Ability to stand, walk, bend, reach, and perform repetitive activities during a 12-hour shift.
• Ability to wear required personal protective equipment.
• Ability to lift and move materials within established site limits.
• Must be able to work the complete 6:30 p.m.–6:30 a.m. rotating night-shift schedule , including alternating weekends and holidays when scheduled.