Batch Record Reviewer II

The Batch Record Reviewer II audits Manufacturing and/or Packaging batch records performs transactions in inventory systems to release batches for further processing (Packaging) and coordinates problem-solving activities including solution implementation.

Responsibilities

• Review and audit the data and records generated by Manufacturing and Packaging Operations in the processing of a material or product batch
• Ensure any batch record errors are corrected all batch record components are present and exception documents are referenced and approved
• Ensure Quality goals are met and all practices and procedures comply with Company policies and applicable regulations
• Develop and implement process improvements for improved compliance and/or efficiencies
• This role will also (depending on facility type);
  Manufacturing Operations:
  Complete basic calculations for product yield.
  Communicate batch release progress or delays to quality and materials management
• Packaging Operations:
  Ensure all in-process and release testing is complete and all Quality holds are released
• Release batch records in electronic systems according to global local customer and regulatory requirements
• Interface with various electronic databases/systems to interpret data pertinent for release to specific countries
• Interact with other AbbVie departments external customers and regulatory agencies
  Ensure batch records are retained and filed securely
• Lead problem-solving activities and coordinate the implementation of identified solutions

Qualifications :

• Minimum High School diploma or GED required; Bachelors or Associates degree desired
• 2 years of overall experience in Manufacturing Quality or Engineering
• Familiarity with POMs electronic batch record system RIMS (Records Information Management System) and OneVault document management systems preferred
• Minimum 5 years experience in a Manufacturing and/or Finishing and/or Packaging environment is desired
• Minimum 2 years experience in Batch Record Release strongly preferred
• Knowledge of GMP regulations and standards affecting pharmaceutical products
• Good verbal and written communication skills
• Demonstrated analytical skills and attention to detail
• Good interpersonal relations/communications skills
• Must be available to work daily overtime including weekends as needed

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time