Documentation Specialist
System One, Chicago, IL, United States
Overview
Leading healthcare company looking for an experienced Documentation Specialist. Ideal candidates should have an Associates degree or 3+ years of experience in manufacturing environment and / or quality documentation.
Responsibilities
Support manufacturing batch documentation review to ensure compliance with cGMP, company policies, and SOPs
Review batch records and GMP documents to verify they meet specifications and are submitted to Quality per release schedule
Ensure batch documentation complies with GDP standards and determine acceptability using specifications and SOPs
Verify the presence of all required documentation prior to submitting batch folders to Quality
Maintain files for easy retrieval and support GME cycle counting as needed
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 preventative maintenance work orders, assign, and complete them as necessary
Use SYSTECH to review and approve batch counts and initiate batch folders through data entry
Perform other administrative duties as assigned
Requirements
Associates degree or 3+ years of experience in manufacturing environment and/or quality documentation
Strong computer skills in MS Office Suite
Knowledge of documentation systems and familiarity with batch/systems documentation preferred
Strong attention to detail and organizational skills
Ability to work with minimal supervision in a dynamic environment following written procedures
Effective verbal and written communication skills across all organizational levels
Willingness to adjust work hours and work overtime based on business needs
Ability to lift up to 30 pounds
Must not be allergic to Penicillin or Cephalosporin drugs
System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Ref: #558-Scientific
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Responsibilities
Support manufacturing batch documentation review to ensure compliance with cGMP, company policies, and SOPs
Review batch records and GMP documents to verify they meet specifications and are submitted to Quality per release schedule
Ensure batch documentation complies with GDP standards and determine acceptability using specifications and SOPs
Verify the presence of all required documentation prior to submitting batch folders to Quality
Maintain files for easy retrieval and support GME cycle counting as needed
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 preventative maintenance work orders, assign, and complete them as necessary
Use SYSTECH to review and approve batch counts and initiate batch folders through data entry
Perform other administrative duties as assigned
Requirements
Associates degree or 3+ years of experience in manufacturing environment and/or quality documentation
Strong computer skills in MS Office Suite
Knowledge of documentation systems and familiarity with batch/systems documentation preferred
Strong attention to detail and organizational skills
Ability to work with minimal supervision in a dynamic environment following written procedures
Effective verbal and written communication skills across all organizational levels
Willingness to adjust work hours and work overtime based on business needs
Ability to lift up to 30 pounds
Must not be allergic to Penicillin or Cephalosporin drugs
System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Ref: #558-Scientific
#J-18808-Ljbffr