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Average salary for this occupation in Heart of Texas
63k
Per year
EMPLOYER LOGO
Quality Laboratories Specialist -Waco ABBVIE US LLC Occupation: Medical and Clinical Laboratory Technologists
Location: WACO, TX - 76702 Positions available: 1
Job #: 14127488
Updated: 10/27/2020 Expires: 10/26/2020
Source: WorkInTexas Site: WorkInTexas

 
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Job Description

Job Description
Oversees microbiological analysis and the release of raw materials, bulk product, and final products. Coordinates and supports method validations and prepares Laboratory/validation reports. This position requires thorough scientific knowledge and technical expertise, technical writing, investigation experience, problem solving and strong regulatory knowledge (FDA/CFR/ISO/USP/EP).
 
Main Areas of Responsibilities
  • Receiving and interpreting the results of microbiological testing for raw material, bulk and finished products.
  • Investigating all out of specification conditions and implementing corrective action.
  • Reviewing and approving laboratory testing documentation.
  • Coordinating testing release with the final Quality Control records.
  • Preparing monthly laboratory reports in conjunction with the microbiology manager.
  • Ensuring that all laboratory supplies, inventory and on-going lab operations do not exceed a specified budget.
  • Ensuring that SOP’s align with regulator expectations, are updated and are available to all laboratory personnel.
  • Ensuring 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. This is performed in conjunction with ensuring that our business practices enhance the welfare of our customers, employees and the community in which we operate.
  • Reviewing current regulatory and technical journals to help provide guidance and to support manufacturing regarding microbiological issues.
  • Any additional tasks/projects as assigned by the laboratory supervisor.
  • This person will may serve as a back-up when the Micro Lab Manager is unavailable.
  • When required, support supplier audits/appraisals, internal, and regulatory audits.

Qualifications
Requirements
  • Knowledge of microbiology and regulatory requirements with minimum of 5 years of industrial microbiology with emphasis in the pharmaceutical and/or medical device industry, or equivalent experience.
  • Minimum of 3-4 years of supervisory experience.
  • MS Office (Word, Excel, PowerPoint).
  • SAP, QMS/Trackwise (preferred), Johnson Controls/FMS (preferred), MODA (preferred)
  • Experience working in a GMP regulated environment.
  • Experience performing and validating microbiological methods.
  • Excellent analytical and problem-solving skills.
  • Ability to understand, use and author technical documents.
  • Excellent written documentation skills (Fluent in English).
  • Proven ability to work effectively with others.
  • Good verbal and written communication skills (Fluent in English).
Education
  • Bachelor's Degree in Microbiology or related Science.


Employer Research

ABBVIE US LLC
Is a Private Sector employer with 15 locations
100-249 employees
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Location/Work Site Information
Compensation and Hours
Salary Range: Not Available DOE (Depends on Experience) Not Available Other Benefits: Not Available Full or Part Time: Full Time (30 Hours or More) Job Duration: Over 150 Days Type of Job: Regular
Shift: Not Applicable
Hours per Week:
Hours Not Specified

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