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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.

QC Chemistry Laboratory Supervisor

Waco, Texas Req ID 2209801 Category Quality Assurance Division AbbVie

Job Summary

Oversees the processes of the chemical analysis and release of raw materials, in-process, and final products. This position requires thorough scientific knowledge and technical expertise in the field of chemistry, technical writing, investigation and problem solving and strong regulatory knowledge. May lead a functional sub-team.

Job Details

This position is responsible for the following:

  • Operates in a technical environment that requires scientific knowledge and technical expertise in the fields of Chemistry, GMP and technical writing. 
  • In association with departmental management, may direct and execute raw materials, in process, final, stability, and complaint product testing programs.
  • Conducts laboratory investigations, including out of specification test results and implements corrective action. 
  • Review and approve laboratory testing documentation and may review and revise Analysis Procedure and Product or Raw Material specifications to maintain regulatory compliance.  
  • Coordinate testing release with the final Quality Control records. 
  • May develop and execute Validation Protocols covering instrumentation, laboratory, and manufacturing procedures as they relate to Chemistry Laboratory issues.
  • Review and revise Chemistry Laboratory Standard Operating Procedures.
  • Ensure that all laboratory employees meet training requirements and work to ensure that the company is in compliance with all regulatory, environmental, health and safety requirements.
  • In association with departmental management, directs and executes safety programs.
  • Assists management in implementing continual improvement to lab processes.   
  • May serve as a back-up when the Chemistry Lab Manager is unavailable.
  • When required, support supplier audits/appraisals, internal, and regulatory audits.
  • Performs other tasks/projects 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.


Education and Experience:

Minimum requirements for this position are:

Education

Bachelor’s Degree in Chemistry or related Science.

Experience:  Technical

Knowledge of chemistry and regulatory requirements with minimum of three (3) years of lab experience in regulated environment with emphasis in the pharmaceutical and/or medical device industry, or equivalent experience

Experience: Supervisory

Two (2) years of Team Leadership experience

Experience: BT Systems

LIMs (preferred)

MS Office (Word, Excel, PowerPoint)

QMS/Trackwise (preferred)

Experience: Regulatory

Experience working in a GMP regulated environment.

Essential Knowledge, Skills & Abilities:

  • Excellent analytical and problem-solving skills
  • Ability to understand, use and author technical documents
  • Excellent written documentation skills
  • Proven ability to work and communicate with others in a professional and effective manner, within a team-oriented environment.
  • Proven Leadership skills.
  • Good oral and written communication skills.
Significant Work Activities: N/A
Travel: No
Job Type: Experienced
Schedule: Full-time
ABBVIE

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