Teva Quality Specialist II 

United States, North Carolina 

237561010

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Carries out responsibilities in accordance with the organization’s policies, procedures, and state, Federal and local laws.
• Issue and update scheduled batch record for Pharmacy and Manufacturing Operations.
• Issue and verify batch records for production.
• Prepare and file documents for Doc Control department.
• Issue field copies for Production and Qualification execution.
• Prepare and file batch records and forms.
• Logs entries for the receipt and archival of documentation (i.e. master batch records, master packaging records, change controls, logbooks, etc.) in the computerized database
• Logs entries for the issuance of logbooks in the computerized database
• Assists or participates in filing quality assurance documents
• Provides customer service representing the Quality Assurance area.
• Responsible for performing additional related duties as assigned.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), and Standard Operating Procedures (SOP’s) instructions.
• Responsible for performing additional related duties as assigned.
  

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

• High School Diploma or equivalent and two (2) years manufacturing and/or quality environment experience preferably in a laboratory or GMP environment or one (1) year of satisfactory performance as Inspector I.

Skills/Knowledge/Abilities:

• Current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs) and Food and Drug Administration (FDA), and other regulatory compliance regulations and standards.
• Quality control practices in the pharmaceutical industry.
• Leadership, project management and training methods and techniques.
• Labeling processes and techniques.
• Principles of mathematics and statistical computations.
• Current Company policies, practices and procedures, including safety rules and regulations.
• Business, scientific and personal computer hardware and software applications.
• Skill levels in MS Office including proficiency in Word, PowerPoint, Excel and SharePoint.
• Must be able to maintain the highest levels of confidentiality, integrity and discretion.
• Excellent verbal, written, and interpersonal skills required.

Problem Solving:

• Works on assignments that are routine to semi-routine in nature where the ability to recognize deviation from accepted practice is required.
• Exercises judgment within specifically defined practices and policies and selects methods and techniques for obtaining solutions.
• Normally receives general instruction on routine work and detailed instruction on new assignments.
• May be asked to recommend methods and procedures for problem resolution.
• Able to identify solutions to general problems through collaboration and creativity.
  

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