QA QMS SPECIALIST – INVESTIGATION

Regular
16 Elkins, East Brunswick
Posted 4 months ago

Job Summary:

 

QMS specialist-investigation is responsible for reviewing and assuring the completeness of investigation, handling, reporting and documentation of Deviations, non- conformances and complaints that are reported. QMS specialist-investigation completes the investigations and closure of the incidents/CAPAs within the time frame. QMS specialist-investigation QMS specialist-investigation will assist in QA supervision and perform other documentation work as required (change controls, MMRs, SOPs, Protocols etc.). The QMS specialist-investigation will directly report to Associate Director QA and will assist throughout the QA documentation when necessary.

 

Reporting Relationships                                                                                  

 

  • This position has no direct reports

    Essential Functions:

     

    • Review deviations, complaints investigations as and when they are notified.
    • As part of each investigation, gather information from all necessary internal and external sources in order to find the root cause and to evaluate the impact of the deviation on manufactured product, as well as the risk to previous products/future operations.
    • The investigator will conduct and drive nonconformance events/deviations to identify root cause, product impact and preventative actions for Manufacturing Operations in support of batch disposition and continuous process improvement. Work with internal teams to obtain an in-depth understanding of the product and the documentation requirements.
    • Work across functions with a professional manner to conduct investigations and works independently to comply with procedure driven guidelines relating to deviation investigations.
    • Produce high-quality investigation documentation that meets applicable standards and is appropriate for its intended audience.
    • Properly assess the manufacturing or analytical environment and independently conceives and initiates appropriate corrective/preventative actions (CAPAs) designed to mitigate Quality deficiencies identified in the investigative process using analytical tools.
    • Track the progress of the open CAPAs and ensure closure of the CAPAs in timely manner.
    • Provides technical assistance to area supervisors or managers to solve complex problems. Exercises judgment in developing practices, techniques and evaluation criteria for obtaining results.
    • Prepare monthly, quarterly and annual investigations/CAPAs trend reports.
    • Ensure completion of training to new hires per procedure and training to current employees as and when needed
    • Review production batch records and perform SAP transactions. 
    • Discover and report any trends in reported deviations/investigations. 
    • Conduct training to employees based on the deviations/CAPAs.
    • Initiate change controls for manufacturing related operations. Author departmental Standard Operating Procedures (SOPs), Protocols, technical reports etc.
    • Supervision of production operation per plan.
    • Prepare monthly production report and present to management.
    • Other duties as assigned.

      Specialized Skills and Knowledge:                                                                                  

       

      • Education/Certifications:
        1. BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent combination of education and experience; 3-5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices including: Manufacturing, Validation and Process engineering.
        2. Pharmaceutical or related FDA work experience strongly preferred.
      • Must know the operation of pharmaceutical production equipment.
      • Experience in solid dosage manufacturing, process, and quality.
      • Demonstrates strong analytical and technical skills.
      • Ability to articulate, discuss and glean information from Manufacturing, QC, QA, RA and engineering personnel to write a complete investigation.
      • Excellent verbal communication and strong written English skills with a proven record of producing technical reports in a clear and concise manner.
      • Strong experience and comprehension of MS Office programs — primarily MS Word and excel.
      • Experience in statistical process control and Trackwise or any other QMS software is a plus.
      • Assures compliance to all procedures and policies concerning all areas of manufacturing, logistics, safety and human resources.
      • May supervise manufacturing personnel in equipment setup and operation of critical production equipment and processes in accordance with cGMP’s, SOP’s, OJT’s, product batch records or other approved company documentation.

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Job Features

Job CategoryQuality Assurance

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