Operator II, Packaging

Responsibilities:

• Competently operates pharmaceutical packaging machinery which may include stamp machines, tape machines, box machines, electronic scales, and other machinery.
• Ensures that all equipment is running properly.
• Executes processes such as: material handling, capping, outserts/med guides, in-process checks, packing, stacking, cartoning, etc.
• Is qualified in Filling and/or Labeling.
• May request components, labels and inserts per the BPR/MPR.
• May set up packaging machinery; may accurately set equipment programming according to BPR's and SOP's.
• Conducts basic sets up, starts, operates, adjusts, troubleshoots and tears down packaging lines.
• Executes Batch Production Record (BPR) or Packaging Master Records (MPR) and logbook documentation with detail and accuracy.
• Accurately reviews BPR's steps for completeness.
• Accuracy conducts sampling: 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
• Executes the procedures used to clean pharmaceutical packaging equipment and facilities.
• Conducts Master Cleans or A & B type Cleans and Line Clearances
• Assists in troubleshooting process issues.
• Identifies and reports processing related issues to Packaging Supervisor or designee and to Quality personnel
• Executes the required in-process product quality checks and documents accurately.
• Demonstrates the ability to work in collaboration with others as a part of a team.
• Stays current on SOPs and cGMPs.
• May participate in training qualifier classes.
• 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
• Other related duties as assigned to meet departmental and Company objectives.

Education & Experience:

• High school diploma or equivalent.
• 1 year of packaging experience or proficiency demonstrated in competencies as required

Skills & Abilities:

• Qualified in Filling or Labeling.
• Competent at all of the following processes:

1. Material handling
2. Capping
3. Outserts/med guides
4. In-process check
5. Packing
6. Stacking
7. Cartoning, if applicable

• Competent in setting up and running machinery.
• Competent in Master Clean/ Line Clearance or A&B type Cleans.
• Competently samples 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.
• Ability to assist in troubleshooting process issues.
• 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.