Pharmaceutical Batch Processing Operator

Join our production team

Be the hands-on expert who turns SOPs and Master Batch Records into safe, compliant pharmaceutical products.

Role snapshot

• Reports to: Manufacturing manager/supervisor
• Supervision: No direct reports

Core responsibilities

• Follow Master Batch Records and SOPs precisely; comply with all company policies and cGMP/FDA regulations.
• Set up, operate, and clean manufacturing equipment; assemble correctly and verify cleanliness before use.
• Sanitize manufacturing rooms (walls, floors, ceilings) to current SOPs; maintain a neat, orderly suite.
• Conduct required in-process tests/inspections; ensure proper execution of all steps in the MBR.
• Complete and sign batch records; keep equipment logs, line-clearance records, and/or lab notebooks accurate.
• Weigh materials and components for batches; stage and verify quantities.
• Identify and report quality issues and any process concerns to the supervisor immediately.
• Notify supervisor at batch completion; transition to new assignments efficiently.
• Report accidents, unsafe conditions, and unusual events to the mfg. manager/supervisor.
• Perform other duties as assigned by management.

Qualifications

• High school diploma or equivalent required.
• Preferred: 1+ year of QA experience and familiarity with FDA/cGMP expectations.
• Excellent attention to detail and documentation accuracy; able to work independently with limited oversight and as part of a team.
• Per FDA expectations, must not have illnesses/conditions that could impact product safety/quality (e.g., contagious illness, bleeding, open lesions, flaking/peeling skin).
• Capable of wearing all required PPE.

Communication and analytical skills

• Fluent in English; able to read/understand procedures and communicate clearly across departments.
• Comfortable presenting information and responding to cross-functional questions.
• Math proficiency: addition, subtraction, multiplication, division, averages, percentages, fractions.

Reasoning and work approach

• Proactive problem identification; asks targeted questions to understand issues fully and resolve quickly.
• Logical, service-oriented; highly organized, reliable, and deadline-driven.
• Available for first and/or second shift and overtime as required; able to perform physical tasks tied to sampling/inspection.
• Strong written and verbal communication to execute documents and collaborate effectively.

Interpersonal strengths

• Accountability for the quality of deliverables.
• Team-first mindset; collaborates to support broader objectives.
• Clear directions/instructions when coordinating tasks; calm under pressure.
• Multitasks without losing focus; adapts positively to change.
• Professional appearance and positive attitude; effective cross-department interaction for manufacturing/packaging success.

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