Pharma QA Records Specialist | Documentation & Compliance

Planet Pharma; Lake Zurich (IL); On-site; USD 28,000 - 40,000; Full time

Job summary

Planet Pharma is seeking a QA Record Specialist to manage and maintain master documents for manufacturing, packaging, and testing. You will support management in projects and ensure accurate processing of Master Batch Records, batch records issuance, testing specs, and laboratory records.

You will coordinate production documentation, resolve discrepancies, and assist in training new staff. This role involves developing documentation to meet validation and study requirements and may participate

Qualifications

• Undergraduate degree in Chemistry or Biology or equivalent combination of education and experience.
• 3-5 years’ experience in the pharmaceutical industry.
• Excellent communication, writing, and proofreading skills.
• Computer skills required.

Responsibilities

• Analyzes and coordinates scheduled production batches to ensure complete and accurate manufacturing documents.
• Prioritizes issuance of all necessary documents for each scheduled product and assigns product expiration date.
• Recognizes and resolves documentation discrepancies and communicates corrective actions.
• Assists management in training newly hired QA Record Specialists.
• Manages documentation projects to support management needs.
• Develops batch records to meet validation protocols and study requirements.
• Attends production scheduling meetings to ensure timely completion of documents.
• Performs other duties as delegated by QA Documentation/MQA Disposition Management.

Skills

Communication

Writing

Proofreading

Computer skills

Education

Undergraduate degree in Chemistry or Biology

Job description

Planet Pharma is seeking a QA Record Specialist to manage and maintain master documents for manufacturing, packaging, and testing. You will support management in projects and ensure accurate processing of Master Batch Records, batch records issuance, testing specs, and laboratory records.

You will coordinate production documentation, resolve discrepancies, and assist in training new staff. This role involves developing documentation to meet validation and study requirements and may participate