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Batch Record Reviewer

Department: Batch Record Review
Location: West Columbia, SC

Position Summary:

  • Responsible for reviewing finished product for overall completeness and correctness per cGMP in the batch records.
  • Assists with additional work duties or responsibilities as evident or required.
  • Performs other duties as assigned or apparent. 

 

Primary Accountabilities:

NOTE: The primary accountabilities below are intended to describe the general content of and requirements of this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks orresponsibilities will be documented in the incumbentsí performance objectives as outlined by the incumbentsí immediate supervisor or manager.

  • Review the batch records for cGMP compliance, SOP deviations, and completeness.
  • Verify that all data, signatures, and dates have been entered.
  • Verify all equipment is within its calibration period.
  • Verify all preventative maintenance was performed.
  • Fully investigate any unexplained deviation from procedure.
  • Assist with training new hires
  • Assist with issuing and approving batch records when needed.
  • Verify prepared Batch Records before sending batch records to production floors when necessary.

 

Knowledge, Skills & Abilities

  • High School Diploma is required; 2 year Associate of Art Degree is preferred. 
  • Experience working in a Pharmaceutical environment as Quality Assurance is preferred.
  • Specific expertise, skills and knowledge within batch record reviewing gained through education and experience.
  • Attention to detail is important
  • The ability and willingness to change direction and focus to meet shifting organizational and business demands.
  • The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
  • The ability to demonstrate integrity, effectively manage oneself, be productive under pressure, and achieve personal and department goals.
  • The ability to manage a multitude of resources and to be accurate and current with data and information.
  • Computer knowledge, people skills, good communication, strong GMP background.
  • Salary range: Based on experience

 

 

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