Quality Optimizer II - QA - 2nd Shift (M-F, 3p-1130p)

Job Title:      Quality Optimizer II

Location:      Columbus, OH

Job Type:      Full time

Req ID:          11820

 

 

 

About Us: 

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 800 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 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

 

Description:

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.

 

Key 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 the