Pharma Documentation Specialist: Compliance & SOP Expert

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

PTO 20 days

Personal days

Medical benefits

Employee discount

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Documentation Specialist to review and approve batch records for cGMP compliance and assist with SOP updates in Operations. You will track document approvals in the VEEVA system and maintain training compliance.

Ideal candidates bring strong documentation skills, attention to detail, and the ability to work independently in a fast-paced manufacturing environment. Onsite role with comprehensive benefits and growth opportunities.

Qualifications

• Minimum: High School diploma or equivalent.
• Preferred: Associate of Science.
• One+ years’ experience in healthcare/pharmaceutical manufacturing or QA.
• Strong knowledge of cGMPs/FDA regulations.

Responsibilities

• Review and approve executed production batch records and related documents.
• Arrange documents within batch records.
• Revise/update SOPs for Operations.
• Maintain cGMP and safety training at 95% completion.
• Support deviation investigations through documentation of findings.
• Attend onsite consistently and punctually.

Skills

SOP writing/revision

Attention to detail

Documentation skills

Verbal & written communication

Time management

Independent work

CFR/cGMP knowledge

Team collaboration

Education

High School diploma or equivalent

Associate of Science

Tools

Microsoft Office

Job description

Hikma Pharmaceuticals USA Inc. is seeking a Documentation Specialist to review and approve batch records for cGMP compliance and assist with SOP updates in Operations. You will track document approvals in the VEEVA system and maintain training compliance.

Ideal candidates bring strong documentation skills, attention to detail, and the ability to work independently in a fast-paced manufacturing environment. Onsite role with comprehensive benefits and growth opportunities.