QA Compliance Specialist: Drive Regulatory Excellence

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 45,000 - 75,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) with company match

20 days PTO

11 company paid holidays

Health, dental, vision coverage

Tuition reimbursement

Career growth opportunities

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Specialist, QA Compliance in Bedford, OH to support the Quality Group by implementing and maintaining compliance policies aligned with regulatory guidance. The role focuses on CAPA, audits, and ongoing regulatory readiness.

The ideal candidate holds a science degree and 3–5 years in pharma quality systems, with knowledge of cGMP and injectable manufacturing practices. This is a full-time position offering comprehensive benefits and growth opportunities.

Qualifications

• Bachelor of Science in Pharmacy, Chemistry, Microbiology, or a related scientific discipline.
• 3–5 years of pharmaceutical industry experience.
• Experience in Quality Systems and Compliance.
• Knowledge of injectables manufacturing processes and cGMP standards.

Responsibilities

• Support CAPA, Change Control, and audits to ensure regulatory compliance.
• Oversee customer complaints and adverse drug reaction program.
• Participate in product trend analysis and Annual Product Review.
• Prepare and review batch records and SOPs in compliance with cGMP.
• Manage internal and external audits.

Skills

Quality Assurance

Regulatory Knowledge

Attention to Detail

CAPA

Audits

Education

Bachelor of Science in Pharmacy

Job description

Hikma Pharmaceuticals USA Inc. is seeking a Specialist, QA Compliance in Bedford, OH to support the Quality Group by implementing and maintaining compliance policies aligned with regulatory guidance. The role focuses on CAPA, audits, and ongoing regulatory readiness.

The ideal candidate holds a science degree and 3–5 years in pharma quality systems, with knowledge of cGMP and injectable manufacturing practices. This is a full-time position offering comprehensive benefits and growth opportunities.