Quality Optimizer II – QA, 2nd Shift

Role Overview

• 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.

Requirements

• B.S. in Biology, Chemistry, Engineering, Pharmacy, or related scientific discipline plus a minimum of 2 years pharmaceutical operations experience.
• In lieu of BS in scientific discipline, High School Diploma or GED plus a minimum of 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
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave