Hikma Pharmaceuticals · 15 hours ago
Quality Optimizer II - Quality Assurance (2nd & 3rd Shift)
Columbus 1809
Full-time
Onsite
Entry, Mid Level
2+ years expHikma Pharmaceuticals USA Inc. is a developer, manufacturer, and supplier of essential medicines committed to better health for millions. The Quality Optimizer II role is responsible for ensuring quality and compliance with regulations and standards, conducting documentation reviews, and supporting production operations to maintain high-quality standards.
Health CareMedicalPharmaceutical
Responsibilities
Perform detailed production documentation review, shop floor support as needed, identify and communicate quality issues,and drive right-first-time (RFT) in production documentation
Specific actions to provide detailed production documentation review:
Perform detailed review of post execution batch documentation (master formula cards, master packaging specifications, electronic batch records)
Support production shop floor with documentation/quality issues as escalated by Production Optimizers
Verify compliance with applicable SOP's, WI's and cGMP practices, providing interpretation and application as needed
Collect quality metric data; Support and drive site/department goals and expectations
Supports implementation of EBR process implementation by executing EBR Process Qualification evaluations and reviews. Ensure EBR documentation system accurately reflects manufacturing process utilizing side-by-side review with current paperlot documentation. Continue developing EBR skill set to become SME. Support continuous improvement of the EBR system through feedback and partnering with the MES team
Develop and deliver training to operations to support RFT and cGMP compliance
Apply knowledge of cGMPs, other regulatory requirements, and internal processes
Represent QA Disposition at Job Board, Performance to Plan, Sequencing and New Product Launch meeting
Drive area procedural robustness and cGMP compliance through document authoring and review (SOPs, WIs, Re-inspection Instructions)
Frequently have to help document a non-standard event during production, maintaining accuracy while effectively communicating critical details so that it can be easily understood by an external auditor. Decision making can significantly impact customer service level. Incorrect judgment concerning corrective action can delay release of product, require re-inspection activities or potentially lead to a market action
A QA Disposition Quality Optimizer II has the authority to perform a detailed review of executed lot documents but does not have the authority to perform final disposition (release or reject) decisions. A QA Disposition Quality Optimizer II has full authority to develop path forward when addressing non-standard events and documentation errors although additional support from the Quality unit or other QA Disposition Quality Optimizers may be needed. Any decision that can be supported by Procedures and cGMPs is within the QA Disposition Quality Optimizer II authority. A QA Disposition Quality Optimizer II is expected to investigate and pursue innovative solutions and techniques to optimize QA Disposition
Peer and supervisor consultation is expected if there is a significant question pertaining to correct path forward. Decisions to refer to a supervisor include instances where there is critical impact and a lack of data, or conflicting data upon which to make the decision
Qualification
Required
B.S. in Biology, Chemistry, Engineering, Pharmacy, or related scientific discipline + minimum of 2 years pharmaceutical operations experience
In lieu of BS in scientific discipline, 6 years of pharmaceutical experience, in an area that provides a knowledgeable background for compliance and quality orientation
Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel), SAP and EBR is a plus
Proven ability to establish and maintain effective working relationships with managers and employees
Possess excellent communication skills with the ability to influence/ persuade individuals of various levels within the organization to gain understanding and/or acceptance of an idea, policy, procedure or plan. Ability to utilize active listening skills to understand the concerns or reasoning in order to be responsive, gain trust and build strategic relationships
Demonstrated ability to perform independent work requiring attention to detail, accuracy and scientific judgment
Proven ability to shift thought processes quickly and accurately from one project to another
Ability to lift 20 pounds
Benefits
Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% 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
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