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Quality Analyst I

Thousand Oaks, CARandstad LifeSciences


Chat with me now! - https://flashrecruit.com/jobs/300386
 

Quality Analyst I

 

Job Summary

Responsible for performing the day-to-day quality operations for QA Form Finish Manufacturing within the Quality organization. Identify and assess quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices. 

Job Responsibilities

  • Responsible for reviewing pertinent documents, records and reports such a Manufacturing Formulation Records (MFRs), Manufacturing batch Records (MBRs), etc. against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc. 
  • Identify areas of non-conformance and inform management via the drafting of Non-Conformance Reports (NCRs) as needed to be disposed (unilaterally accepted or rejected) by others. NCRs at this level are minor and involve no patient risk 
  • Performs initial investigative actions on NCRs, applying well-established techniques and procedures 
  • Administer and maintain relevant databases, preparing and issuing reports as defined by the area. 
  • Assist in external and internal audits by maintaining audit records, extracting data from databases and creating reports, collecting relevant data, etc. 
  • Revise or review standard procedures. Revise SOPs in support of Division Procedure Compliance or continuous improvement efforts as needed. 
  • Maintain and update departmental business indicators. Prepare metrics for the Management Review of Quality Systems. 
  • Audit/review documents as needed for completeness, cGMP’s, company procedures and verification of data. Correct any deficiencies found. 
  • May perform other duties as assigned. 

Education & Qualifications 

  • Associate degree in a scientific discipline and one to three years of relevant experience within most recent 5 years or an equivalent combination of education and experience.
  • Bachelor’s degree in the life sciences, business or other technical field preferred.
  • Strong interpersonal skills and great attention to detail are necessary.
  • Must be a strong team player with good problem solving, and good verbal and written communication skills.
  • Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, and Application of Good Manufacturing Practices. 
  • This position requires shift, weekend and holiday work. 
  • May be required to travel for business reasons, e.g. training and meetings. 
  • Must be able to work in controlled or clean room environments requiring special gowning.
  • Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. 
  • May be exposed to dust, gases, and fumes. 
  • May be around moving equipment and machinery. 
  • May work around Metnotrex, which is a known cell growth inhibitor. 
  • May be working in a loud area that requires hearing protection and other protective equipment to be worn. 
  • May work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection. 
  • Inside working conditions. 
  • May require immunization before performing work within the manufacturing area. 
  • May be required to work or be assigned to a different shift as needed. 
  • Must be able to work more than 8 hours a day or 40 hours a workweek as required. 
  • Overtime may be required at times. 

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

 


Chat with me now! - https://flashrecruit.com/jobs/300386