GMP Compliance 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

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.