Lead Packaging Operator

Compensation

: $29,530.00 - $46,830.00 /year *

Employment Type

: Full-Time

Industry

: Consumer Product/Consumer Packaged Goods/Packaging



Job Description

SUMMARY / OBJECTIVE Under minimal supervision, this position is responsible for performance of clinical packaging operations including both manual activities (such as labelling and kitting) and the operation of automated and semi-automated equipment (such as bottling and blistering) in a GMP environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Assist in the development of new processes in procedures under the management direction including:
  • Becoming subject matter expert for clinical packaging equipment.
  • Assist in adapting equipment understanding into new SOPs and work instructions and assist in the training of additional staff on equipment specialty.
  • Front line troubleshooting for processes and equipment.
  • Perform Packaging Manufacturing activities including:
  • Materials sampling, staging, dispensing, and return.
  • Read understand batch records and work instructions.
  • Packaging Equipment and Room set-up, operation, and cleaning.
  • Use of appropriate personal safety equipment and engineering controls.
  • Use Experic IT Platform.
  • Support investigational and quality systems activities.
  • Assist maintenance in the performance of preventative maintenance activities, troubleshooting and repair of equipment.

ADDITIONAL POSITION REQUIREMENTS

  • Carries out duties in compliance with all federal and state regulations and guidelines.
  • Complies with all company and site policies and procedures.
  • Mechanical Aptitude, curiosity to explore complex machinery, and a desire to learn new processes.
  • An ability to learn and remain self-directed on task that are both well-defined and more exploratory.
  • Learn, become and remains current in profession and industry trends.
  • Makes a positive contribution as demonstrated by:
    • making suggestions for improvement.
    • learning new skills, procedures and processes.
  • Is available for other duties as required.
  • Is available for overtime as needed.

SUPERVISORY RESPONSIBILITIES

None.

QUALIFICATIONS: EDUCATION and/or EXPERIENCE

Requires a High School Diploma or GED plus four (4) years of experience in clinical packaging operations or clinical packaging quality.

LANGUAGE SKILLS

  • Read, and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications.
  • Legible Handwriting
  • Communicate clearly in writing and orally including in the creation of standard operating procedures and work instructions.

MATHEMATICAL SKILLS

  • Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios and proportions to practical solutions.

REASONING ABILITY

  • Identify simple and moderate problems related to job function.
  • Deductive Reasoning ' Demonstrated experience applying general and complex rules to specific problems to produce answers that make sense.
  • Inductive Reasoning ' Demonstrated experience applying a logical process in which multiple premises, all believed true or found true most of the time, are combined to obtain a specific conclusion (includes finding a relationship among seemingly unrelated events).

OTHER SKILLS, ABILITIES OR QUALIFICATIONS

  • Knowledge of cGMP.
  • Experience with Clinical Packaging Operations preferred.
  • Successfully completes regulatory and job training requirements.
  • Computer skills:
    • Enter data into computer using software applications for data entry and word processing.
    • Work and be proficient with e-mail systems.
  • Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
  • Ability to work individually in a self-directed manner with less than daily oversight.
  • Ability to work with others in a team environment.

PHYSICAL DEMANDS

  • While performing the duties of this job, the employee is frequently required to stand, walk, use hands to touch, handle or feel, and talk or hear.
  • The employee is occasionally required to sit and reach with hands and arms.
  • The employee must be able to lift and/or move up to 50 pounds frequently.
  • The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
  • Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

TRAVEL

  • Travel will be required less than 10% of the time, domestic and international.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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