Hikma Pharmaceuticals · 6 hours ago
Quality Assurance Associate
Dayton
Full-time
Onsite
Mid Level
$57K/yr - $85K/yr
4+ years expHikma Pharmaceuticals is a developer, manufacturer, and supplier of essential medicines. They are seeking a talented and motivated Quality Assurance Associate responsible for performing QA activities, ensuring compliance with Good Manufacturing Practices (GMPs), and identifying any deviations or non-conformances.
Health CareMedicalPharmaceutical
Responsibilities
Regular and predictable onsite attendance and punctuality
Perform monitoring of Compounding in the aseptic processing area
Perform AQL inspection for Finished products
Perform in-coming raw material, component, and labeling inspection and release
Review executed batch records to ensure compliance with approved procedures, and communicate and resolve discrepancies with manufacturing operators and supervisors
Provide Quality support to Manufacturing personnel on the floor – providing guidance during GMP events and initiation of deviations and investigations
Lead small scope projects, as assigned
Prepare and/or revise SOPs to ensure compliance with regulations and current practices. Keep current with regulations and industry best practices and update SOPs to improve compliance
Prepare all necessary reports in a timely manner to meet compliance requirements and business needs
Participate in Process Validation activities, including protocol execution and reporting, as necessary
Working knowledge of FDA regulations and application of GMPs
Qualification
Required
Bachelor's degree in relevant science or engineering discipline
4+ years of relevant cGMP experience
Hands-on experience with batch record review and product disposition
Hands-on experience with ERP, Documentation, and LIMS systems
Strong written and verbal skills
Demonstrated effectiveness in task completion, decision making, and problem solving
Excellent writing and computer skills and ability to present data in a logical manner
Excellent interpersonal and communication skills
Excellent organization and time management skills
Ability to work in a high-paced team environment
Working knowledge of FDA regulations, application of GMPs
Preferred
The qualified candidate must possess a strong background in Quality Assurance, Quality Compliance and Quality Systems
Experience in a 503B Compounding manufacturing environment
Experience in FDA/EMA regulations in biopharmaceuticals or sterile injectable manufacturing is preferred
Work in an aseptic processing environment
Experience with use of complex research techniques and methodologies like six sigma and Kaizen to improve process/product quality
Benefits
Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave
Company
Hikma Pharmaceuticals
Hikma focuses on a wide range of generic, branded generic and in licensed pharmaceutical products
5001-10000 employees
H1B Sponsorship
Hikma Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (23)
2023 (22)
2022 (24)
2021 (28)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
International Finance Corporation
2025-07-15Post Ipo Debt· $250M
2005-11-04IPO
Leadership Team
Said Darwazah
Chief Executive Officer
Khalid Nabilsi
Chief Financial Officer
Recent News
Pharma Letter
2026-01-22
BioWorld Financial Watch
2026-01-21
bloomberglaw.com
2026-01-17
Company data provided by crunchbase