With demonstrated packaging knowledge and experience, performs moderate to 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 Filling or Labeling.  Assists in troubleshooting process issues.  Responsible for the safe and efficient execution of job duties, while ensuring product compliance to established standards.    

All incumbents are responsible for following applicable Division & Company policies and procedures.

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.