Operator III, Packaging - 2nd shift

POSITION SUMMARY

With thorough knowledge and skills in all areas of the packaging process, performs more advanced functions relating to the packaging of drug products consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Is qualified in both Filling and Labeling. Is qualified and capable of competently running all packaging equipment across the entire packaging department. Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards. May serve as back-up to the Senior Packaging Technician.

ESSENTIAL FUNCTIONS

Packaging Operations

• Is qualified and capable of competently running all packaging equipment across the entire packaging department
• Is qualified in both Filling and Labeling
• Ensures that all equipment is running properly
• Executes processes such as: material handling, capping, outserts/med guides, in-process checks, packing, stacking, cartoning, etc.
• May request components, labels and inserts per the BPR
• Sets up packaging machinery; accurately sets equipment programming according to BPR's and SOP's
• Sets up, starts, operates, adjusts, troubleshoots and tears down packaging lines
• Executes Batch Production Record (BPR) and logbook documentation with detail and accuracy
• Accurately reviews BPR's steps for completeness and accuracy
• Collects samples from each batch and submits to QA for retained samples
• Demonstrates the ability to execute procedures and complete tasks in a compliant and safe manner

Equipment Cleaning

• Conducts verification of line/equipment cleaning and documents per SOP
• Executes the procedures used to clean pharmaceutical packaging equipment and facilities
• Conducts Master Cleans and Surface Cleans

Continuous Improvement

• Identifies 6S opportunities and sustains the 6S process
• Assists in troubleshooting process issues

Issues and Deviations

• Identifies and reports processing related issues to Packaging Supervisor and to Quality personnel.

Quality

• Executes the required in-process product quality checks and documents accurately.

Teamwork and Collaboration

• Demonstrates the ability to work in collaboration with others as a part of a team.

Training

• Stays current on SOPs and cGMPs.
• May participate in training qualifier classes.

Safety and Compliance

• Participate in safety teams, start-up discussions, incident debriefs, etc.
• Carries out processing/packaging activities safely, as required, on a daily basis.
• Follows all safety and compliance procedures and participates in required training.
• Adheres to all cGMP compliance/regulatory mandates and quality requirements.
• Ensures compliance with SOPs, Policies and Procedures as required by Par and regulatory agencies

Misc.

• Other related duties as assigned to meet departmental and Company objectives.

QUALIFICATIONS

Education & Experience

• High school diploma or equivalent.
• 3 years of packaging experience

Knowledge & Skills

• Knowledge of cGMP regulations and processes.
• Qualified in both Filling and Labeling
• Qualified and capable of setting up and running all machinery in the value stream
• Competent in Master Clean/Surface Clean
• Ability to sample batches
• Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation
• Ability to accurately and precisely record data and batch information
• Ability to work in both independent and team environments
• May become a certified trainer and provide certified training in one process
• Effectively interfaces with other department personnel if Senior level (4th level) isn’t available
• Ability to troubleshoot process issues
• Ability to Identify 6S opportunities and sustain the 6S process
• Ability to participate in Continuous Improvement projects
• Proficient in reading and writing English to understand work instructions and document results

Physical Requirements

• Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
• Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.
• Vision - ability to see details at close range (within a few feet of the observer).
• Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.