JOB SUMMARY:

The role of Production Operator II is a mid-level position within our manufacturing department, tasked with proficiently carrying out manufacturing procedures and operating diverse manufacturing equipment. This position requires strict adherence to company Standard Operating Procedures (SOPs), compliance with cGMP guidelines, and a commitment to upholding environmental, health, and safety standards. The Production Operator II ensures that operations meet high compliance and quality standards.

SPECIALIZED SKILLS AND KNOWLEDGE:

• Basic mathematical skills.
• Good mechanical abilities.
• Basic computer skills
• Excellent verbal and written communication skills in English
• Must complete departmental SOP, GMP, and any required Qualifications.
• Ability to work in a team.

EXPERIENCE AND EDUCATION

• High school diploma or equivalent.
• Minimum of 3 years of previous manufacturing experience in the pharmaceutical industry with soft gel encapsulation experience preferred.

ESSENTIAL FUNCTIONS AND DETAILED DUTIES

• Must be able to fully perform all Production Operator I tasks, including operating manufacturing equipment independently, including setup, cleanup, sanitization, material movement, and safely operating the manufacturing equipment to perform manufacturing functions in two processes/machines such as coating, compression, encapsulation, granulation/blending and soft gel function per Manufacturing batch record.
• In addition, must be able to:
• Perform intermediate mechanical functions, including troubleshooting, correcting machine malfunctions, and identifying problems such as bottlenecks.
• Clearly document activities in batch records, forms and other GMP documents.
• Offer suggestions to superiors and follow up on process improvements related to safety, compliance, cost, and productivity.
• Identify and report both machine or manual deviations to supervisor or designee.
• Operator will have intermediate knowledge of multiple manufacturing machines.
• After 1 year of experience and consistently satisfactory performance, able to train Level I Operators and help guide new Level II Operators.
• Follow all Good Manufacturing Practices (GMP) and guidelines.
• Adhere to cGMP’s and Standard Operating Procedures as required. Must report unsafe conditions, near misses, and/or injuries in a timely manner.
• Maintain a clean and sanitary workplace.
• Follow applicable safety guidelines while operating the production equipment.
• Be able to perform other duties as assigned.