Quality Optimizer II - Quality Assurance (2nd & 3rd Shift)

Hikma Pharmaceuticals USA Inc.•Columbus, OH

About The Position

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them. We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Quality Optimizer II, QA . In this role, you will be responsible for ensuring quality and compliance with government regulations and Hikma standards to support the on-going review/audit of batch documentation, release of drug products and supply chain commitments consistent with standard operating procedures and department procedures.

Requirements

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.

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.
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.
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.

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
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave