USA - Documentation Specialist

Planet Pharma; Illinois; On-site; USD 45,000 - 65,000; Full time

Job summary

A pharmaceutical company is seeking a qualified candidate for a position involving the review of manufacturing documentation. The role includes ensuring compliance with cGMP, conducting batch record reviews, and maintaining documentation standards. Ideal candidates will possess strong MS Office skills, attention to detail, and the ability to work independently in a fast-paced environment. An Associate's degree or relevant experience in manufacturing quality documentation is required. Flexible work hours and the ability to lift 30 pounds are also necessary.

Qualifications

• Strong computer skills in MS Office Suite are necessary.
• Knowledge of documentation systems and experience with batch documentation is required.
• Strong attention to detail is critical for reviewing documents accurately.
• Must be able to work independently with minimal supervision and organize tasks efficiently.
• Excellent verbal and written communication skills are essential for conveying information effectively.

Responsibilities

• Support manufacture batch documentation review process.
• Ensure batch records compliance with specifications and submit them on time.
• Author Non-Conformance Records and document changes as required.
• Maintain organized documentation files for retrieval.
• Initiate and close GME work orders for the department.

Skills

Strong computer skills in MS Office Suite

Knowledge of documentation systems

Strong attention to detail

Ability to work independently

Efficient verbal and written communication

Identify areas for continuous improvement

Willingness to adjust work hours

Must be able to lift 30 pounds

Must not be allergic to Penicillin or Cephalosporin drugs

Education

Associate's degree or 3+ years of experience in manufacturing or quality documentation

Job description

Summary

Position reports to Manufacturing functional areas and provides the Manufacturing documentation review. Responsibilities include reviewing batch records and other GMP documents to ensure compliance with cGMP, Company Policies, and local SOPs.

Responsibilities

• Support manufacturing batch documentation review.
• Ensure batch records meet specifications and are submitted to Quality per release schedule.
• Assure batch documentation complies with GDP standards.
• Determine acceptability using specifications and SOPs.
• Ensure presence of all required documentation before submission of batch folder to Quality.
• Maintain files to keep documents readily available and 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 preventive maintenance work orders; assign and bring to completion as necessary.
• Use SYSTECH to review and approve batch counts.
• Initiate batch folders by performing necessary data entry.
• Support GME cycle counting as needed.
• Perform other administrative duties as assigned.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Strong computer skills in MS Office Suite.
• Knowledge of documentation systems and familiarity with batch/systems documentation.
• Strong attention to detail.
• Work independently with minimal supervision in a dynamic environment while following written procedures; 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.
• Willingness 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 Experience

• Associate's degree or 3+ years of experience in a manufacturing environment and/or quality documentation.