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Pharmaceutical Technician, Packaging, 2nd Shift
2 months ago
The Pharmaceutical Technician will efficiently, effectively, and safely clean, set-up, and operate machinery in the packaging area while adhering to applicable cGMPs, SOPs, FDA, and DEA guidelines.
Key Responsibilities:- Equipment Maintenance: Safely and in compliance with batch records and standard operating procedures, perform hands-on set-up (assembly/disassembly), operation, repair, adjustment, and cleaning of production equipment.
- Batch Record Management: Follow Master Batch Records for the manufacture of controlled, oral solid dose (OSD) and other dosage forms when required.
- Production Support: Perform assigned production tasks to ensure timely completion of orders. Record all operations in batch records, logbooks, and other controlled documents.
- Material Management: Prepare, verify, and load raw materials, blends, and ensure bulk product accountability throughout packaging processes.
- Quality Control: Perform in-process inspection and testing for incoming, dispensed materials and packaged products ensuring compliance with established procedures.
- Measurement and Calibration: Set-up, verify, level, challenge, and operate scales, balances, and other types of measurement tools.
- Problem Solving: Identify, report, and resolve quality or machine efficiency issues.
- Cleaning and Sanitation: Clean and sanitize packaging suites including walls, floors, and ceilings per SOPs.
- Labeling and Packaging: Process labeling and components correctly; transferring, counting, FIFO, returns, etc. during packaging processes.
- Team Collaboration: Actively participate in Production team and Site communication meetings.
- Attendance and Availability: Maintain regular and punctual attendance; work overtime as required.
- Education: High School Diploma or equivalent.
- Experience: Minimum one - five years of pharmaceutical industry experience or an equivalent combination of education, demonstrated mechanical skill, and experience in a similar industry.
- Mathematical Computation: General ability to perform basic to complex mathematical computations of addition, subtraction, multiplication, and division. Understanding of the Metric System of Measurement.
- Industry Knowledge: Experience in oral solid dose (OSD) pharmaceuticals- Prior experience in one or more of the following area: Packaging
- Quality and Compliance: Achieve a standard of excellence with work processes and outcomes while maintaining compliance with policies and all regulatory requirements.
- Communication: Clear, accurate, effective, and timely written and verbal communication. Strong attention to detail and ability to write and record data legibly and accurately in accordance with cGMP regulations.
- Teamwork and Collaboration: Work effectively with others to achieve goals, and build strong working relationships and a positive work environment.
- Critical Thinking and Problem Solving: General ability to collect, organize and analyze data. Ability to recognize, analyze, and solve a variety of problems.
- Initiative and Adaptability: Ability to take ownership of work, doing what is needed without being asked and appropriate follow-through. Being receptive to feedback, willingness to learn, and open to continuous improvement.
- Operational Excellence: Embrace and support Operational Excellence Culture and Initiatives.
- Accountability: Demonstrate ambition and discipline to achieve organizational and career goals.
- Availability: Ability to work a 10.5 hour per day/4-day work week, Monday - Thursday with overtime as required.
