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AbbVie Manufacturing Operator III, UD Fill, B2 (7 PM-7 AM W/Th/Fri & every other Saturday) in Waco, Texas

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 (https://twitter.com/abbvie) , Facebook (https://www.facebook.com/AbbVieGlobal) , Instagram (https://www.instagram.com/abbvie/?hl=en) , YouTube (https://www.youtube.com/user/AbbVie) and LinkedIn (https://www.linkedin.com/company/abbvie) .

Job Summary

Responsible for creating, formatting, and improving compounding department Standard Operating Procedures (SOP) and Procedures required for manufacturing base on cGMP.

Job Details

This position is responsible for the following:

  • Create Manufacturing documents as required by new product formulations.

  • Revise Manufacturing Processing Procedures based on organizational needs/requirements.

  • Track all changes required and submit within Global Trackwise (as applicable) on time and Right First Time (RFT)

  • Improve document flow for ease of use to operators during manufacturing reducing the potential for documentation errors.

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 - External

Education and Experience:

Minimum requirements for this position are:

Education

High School Diploma or GED equivalent and/or Associate’s Degree with five (5) years regulated Compounding experience, OR B.S. in the Sciences preferred.

Experience: Technical

At least two (2) years of related work experience, preferably in a high-speed production or manufacturing environment.

Experience: Regulatory

Experience working in a GMP regulated environment preferred.

Experience: Systems

Basic user knowledge of Microsoft Office, SAP experience preferred.

Essential Knowledge, Skills & Abilities:

  • Ability to perform detailed tasks and document activities completely and accurately.

  • Ability to think and plan in a logical sequential order.

  • Ability to work any shift (up to 12-hours) as required dependent on business needs.

  • 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.

Principal Accountabilities

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

% Time

Task #

Description of Task

85%

1.

Responsible for creating, formatting, and improving compounding department Standard Operating Procedures (SOP) and Procedures required for manufacturing base on cGMP

5%

2.

Actively participate in departmental meetings and contribute to the achievement of the following Department performance indicators:

*Reduction of batch errors and deviations,

*Consistent compliance with cGMP’s by avoiding significant cGMP violations, and successful FDA audits with no major observations.

5%

3.

Maintain on time closure of Global Trackwise items ensuring all applicable changes are made in a timely manner without jeopardizing quality of flow to the manufacturing procedures.

5%

4.

Satisfactory performance in complying with all safety rules and procedures, effective contribution in identifying and preventing accidents and unsafe working conditions. Individual participation in meeting the accident frequency goal.

Qualifications

Work Environment

  • Frequently works in an office setting amongst peers.

  • Sitting or Standing for long durations

  • May occasionally required access to clean room environment

  • Potential to encounter slick floor and portable processing equipment.

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.

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