AbbVie

Manufacturing Operator III, UD Fill, A1

Employer
AbbVie
Location
Waco, Texas
Posted
Jun 03, 2021
Ref
2107056
Required Education
High School or equivalent
Position Type
Full time
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

 

Job Title

Manufacturing Operator III

Supv. Title

Supv, Manufacturing

Dept

(Gel / Multi-Dose Fill / Ointment / Packaging / Plastics / Unit Dose)

Prepared By

Human Resources

Location

Waco, TX

  Job Summary

Perform production line duties required to meet production goals while complying with quality standards and safety requirements.  Operate production equipment and complete documentation in accordance with cGMP’s and department SOP’s while monitoring product to ensure quality standards are maintained.

Job Details

This position is responsible for one or more of the following duties or activities (See individual department areas in this document for specific accountabilities):

  • Maintain a clean and organized work area during and at the end of each shift.
  • Assist in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies.
  • Perform all assigned duties according to departmental SOP’s and cGMP’s.
  • Remain current on proper procedures by reviewing current, revised, and new SOP’s relating to the job and to the department.
  • Complete and remain current with all required cGMP and safety training.
  • Perform tasks in the production / packaging of product to provide on-time delivery to customers.
  • Complete all required documentation associated with the production and / or packaging of product.
  • Assist daily production in operating and monitoring technical, computerized, production machinery, ensuring quality standards are maintained.
  • Perform other duties as assigned.

Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.

Regulated Responsibilities (including cGMP and EHS)

Incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.

Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.


Qualifications
Education and Experience:

Minimum requirements for this position are:

Education

High School degree or equivalent.

Experience: Technical

Previous experience working in a manufacturing setting preferred.  Previous experience with high speed production lines and equipment preferred.

Experience: Regulatory

Experience working in a GMP regulated environment preferred.

Experience: Aseptic

Experience working in an Aseptic Production environment preferred.

  Essential Knowledge, Skills & Abilities:
  • Detail-oriented and self-motivated
  • Excellent hand-eye coordination and manual dexterity.
  • Excellent math skills; ability to add, subtract, multiply, and divide. 
  • Ability to read, comprehend, write, and communicate effectively in English.
  • Ability to carry out detailed written or oral instructions.
  • Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
  • Basic user knowledge and understanding of Windows based computer systems such as Microsoft Office, with an ability to learn other computer-based systems.
  • Ability to work any shift (up to 12-hours) as required dependent on business needs.
  • Physically able to continuously stand and walk.
  • Physically able to lift up to 40 lbs. for men and 35 lbs. for women.
  • Physically able to bend, climb, lift, squat, stoop, and stretch to reach frequently.
  • Effective and efficient operation of manual and automated production equipment.
  • Ability to use, clean, and store tools and other devices required for the performance of the job in a manner which prevents damage to the tools and / or equipment.

Principal Accountabilities

Percent indicated is the average time spent on a task and will vary depending on the workflow.

Gel Department

 

% Time

Task #

Description of Task

70%

1.

Responsible for assisting with the Production / Packaging of product in the Gel manufacturing areas using high-speed, advanced production equipment, monitoring product, making minor adjustments, and maximizing efforts to meet production goals without compromising quality.  Ensures that equipment is operating in a safe and efficient manner.  Monitors and maintains quality of the product in order to ensure that quality standards are met, and a minimum of in-process loss is incurred.  Coordinate with Maintenance, as needed, to resolve mechanical and quality issues in an effective and timely manner.  Removes all trash and rejects from the Gel area and disposes of them properly.  Helps keep waste and rejects to a minimum, recycling when possible.  May be required to check the Gel VWR supply closet to ensure needed production supplies are available.  Inspects area daily for cGMP compliance and good housekeeping.  Notify supervisor and/or shift coordinator of equipment and quality issues.

10%

2.

Complete all required documentation in an accurate, legible, and timely manner, with strict adherence to SOP’s, cGMP’s, and ISO guidelines.  Documentation includes, but is not limited to, batch records and log books. 

10%

3.

Cleans controlled rooms for the Gel areas.  Mixes cleaning solutions per SOP and mops the controlled rooms for the Gel compounding and filling areas.  Documents cleaning activities on the cleaning work order for each department. 

10%

4.

 

 

 

 

Functions as a contributing team member through attendance at team meetings, supervisor meetings, and department training sessions, or other informational meetings as required.  Actively provides input and suggestions to help analyze and resolve production problems. Continuously looks for ways to improve work processes.  May be required to provide development and training to less experienced team members. 

Listen and be responsive to team member’s needs.  Be willing to be flexible in achievement of team and department goals.


Significant Work Activities
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.