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:
- Material handling
- Capping
- Outserts/med guides
- In-process check
- Packing
- Stacking
- 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.
|
