Pharma Documentation Specialist — Compliance & SOP Expert

RXinsider LTD.; Bedford (OH); On-site; USD 42,000 - 62,000; Full time

Benefits offered by this job

Annual bonus

401(k) program

PTO

Holidays

Health benefits

Tuition reimbursement

Job summary

Hikma Pharmaceuticals USA Inc. seeks a Documentation Specialist in Bedford, Ohio to review and approve batch records and support GMP-compliant documentation processes. The role involves organizing batch records, updating SOPs, and ensuring training compliance.

Strong attention to detail and familiarity with cGMP/FDA regulations are essential for success. The position is full-time onsite with comprehensive benefits, opportunities for growth, and cross-functional collaboration across the

Qualifications

• High School diploma or equivalent required.
• Associate of Science preferred.
• 1+ year experience in healthcare/pharma manufacturing or QA preferred.
• Strong knowledge of cGMP and FDA regulations.

Responsibilities

• Review and approve executed production batch records and related documents.
• Arrange documents within a batch record accurately.
• Revise/update SOPs for Operations.
• Maintain cGMP training and complete required training (95%+).
• Assist in deviation investigations through documentation of findings.

Skills

SOP writing

Attention to detail

Communication skills

Time management

Teamwork

cGMP/FDA knowledge

Documentation

Education

High School diploma or equivalent

Associate of Science

Tools

Microsoft Word

Microsoft Excel

Job description

Hikma Pharmaceuticals USA Inc. seeks a Documentation Specialist in Bedford, Ohio to review and approve batch records and support GMP-compliant documentation processes. The role involves organizing batch records, updating SOPs, and ensuring training compliance.

Strong attention to detail and familiarity with cGMP/FDA regulations are essential for success. The position is full-time onsite with comprehensive benefits, opportunities for growth, and cross-functional collaboration across the