Packaging Operator l - 2nd Shift

Manufacturing & Packaging Chestnut Ridge, New York


Description

Job Summary - a concise overview of the job

Learns and performs basic 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). 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.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Supports packaging lines as needed.

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Packaging Operations

§  Learns and executes under supervision the skills necessary to operate pharmaceutical packaging machinery which may include stamp machines, tape machines, box machines, electronic scales, and other machinery.

§  Learns and executes processes such as: material handling, capping, outserts/med guides, in-process checks, packing, stacking, cartoning, etc.

§  May learn and perform basic equipment set ups.

§  Learns and executes under supervision the skills necessary to ensure proper carton counts of product containers.

§  May learn and execute sampling.

§  Learns and executes under supervision Batch Production Record (BPR) or Master Packaging Record (MPR) and logbook documentation with detail and accuracy.

§  Demonstrates the ability to execute procedures and complete tasks in a compliant and safe manner.

85-95%

Equipment Cleaning

§  Learns and executes under supervision the procedures used to clean pharmaceutical packaging equipment and facilities.

§  Learns to do either Master Clean/Line Clearance or A&B type clean.

Continuous Improvement

§  May participate in Continuous Improvement projects.

0-5%

Issues & Deviations

§  Learns to identify and report processing related issues to the Packaging Supervisor or designee.

0-5%

Quality

§  Learns and executes the required in-process product quality checks and documents accurately.

5%

Collaboration

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

continuous

Training

§  Learns and stays current on SOPs and cGMPs.

continuous

Safety & Compliance

§  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.

§  Participate in safety teams, start-up discussions, incident debriefs, etc.

§  Ensures compliance with SOPs, Policies and Procedures as required by Par and regulatory agencies.

continuous

Misc.

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

 

Total

100%

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

§  High school diploma or equivalent.

§  0 years previous work experience.


Knowledge

Proficiency in a body of information required for the job  

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

§  Learns cGMP regulations and processes.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

§  Ability to learn and perform Master Clean/Line Clearance.

§  Basic math, writing skills, and problem solving abilities.

§  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.

§  Basic understanding of mechanical machinery and the operating principles of control systems.

§  Ability to work in both independent and team environments.

§  Proficient in reading and writing English to understand work instructions and document results.

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

§  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.