Quality Optimizer II – QA, 2nd Shift

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.
• Support implementation of E  process implementation by executing E  Process Qualification evaluations and reviews.
• Ensure E  documentation system accurately reflects manufacturing process utilizing side-by-side review with current paperlot documentation.
• Continue developing E  skill set to become SME.
• Support continuous improvement of the E  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.

• 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 E  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.