USA - Documentation Specialist
Planet Pharma, Chicago, IL, United States
Summary
This position reports to the Manufacturing functional areas. The role provides the Manufacturing documentation review. Review the batch record or any other GMP document to ensure compliance with cGMP, Company Policies and local SOPs. Essential Duties And Responsibilities
Supporting manufacturing batch documentation review. Responsible for ensuring manufacturing batch records meet specifications and submitted to Quality per release schedule. Assure batch documentation complies with GDP standards. Determine acceptability by using specifications and standard operating procedures. Ensure presence of all required documentation prior to the submission of batch folder to Quality. Maintain files such that documents are readily available and easily retrievable. Initiate and close GME work orders. Author Non-Conformance Records (NCRs) and Exceptions Investigations. Author TCU documentation changes including revisions, periodic reviews and GAP assessments. Use Maximo system to print department preventative maintenance work orders; assign and bring to completion, as necessary. Use SYSTECH to review and approve counts for batches. Initiate batch folders by performing necessary data entry. Support GME cycle counting as needed. Other administrative duties as assigned. Qualifications
Strong computer skills in MS Office Suite. Knowledge of documentation systems and familiarity with batch/systems documentation preferred. Strong attention to detail. Individual will work with minimal supervision in a dynamic environment while following written procedures. Must be organized and able to prioritize tasks. Ability to communicate efficiently verbally and in writing with all levels of the organization. Identify areas for continuous improvement. Individual must be willing to adjust work hours and work overtime based on business needs. Must be able to lift 30 pounds. Must not be allergic to Penicillin or Cephalosporin drugs. Education And/Or Experience
Associates degree or 3+ years of experience in manufacturing environment and / or quality documentation. Equal Opportunity Statement
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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This position reports to the Manufacturing functional areas. The role provides the Manufacturing documentation review. Review the batch record or any other GMP document to ensure compliance with cGMP, Company Policies and local SOPs. Essential Duties And Responsibilities
Supporting manufacturing batch documentation review. Responsible for ensuring manufacturing batch records meet specifications and submitted to Quality per release schedule. Assure batch documentation complies with GDP standards. Determine acceptability by using specifications and standard operating procedures. Ensure presence of all required documentation prior to the submission of batch folder to Quality. Maintain files such that documents are readily available and easily retrievable. Initiate and close GME work orders. Author Non-Conformance Records (NCRs) and Exceptions Investigations. Author TCU documentation changes including revisions, periodic reviews and GAP assessments. Use Maximo system to print department preventative maintenance work orders; assign and bring to completion, as necessary. Use SYSTECH to review and approve counts for batches. Initiate batch folders by performing necessary data entry. Support GME cycle counting as needed. Other administrative duties as assigned. Qualifications
Strong computer skills in MS Office Suite. Knowledge of documentation systems and familiarity with batch/systems documentation preferred. Strong attention to detail. Individual will work with minimal supervision in a dynamic environment while following written procedures. Must be organized and able to prioritize tasks. Ability to communicate efficiently verbally and in writing with all levels of the organization. Identify areas for continuous improvement. Individual must be willing to adjust work hours and work overtime based on business needs. Must be able to lift 30 pounds. Must not be allergic to Penicillin or Cephalosporin drugs. Education And/Or Experience
Associates degree or 3+ years of experience in manufacturing environment and / or quality documentation. Equal Opportunity Statement
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr