The QA Associate II – Plant Quality Operations is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Primary responsibility for this role is Batch Records Review and Product Release. Additional QA support areas include but are not limited to Shop Floor, Standard Operating Procedures, Investigations, CAPA, Change Control, and Shop Floor Walkthroughs. The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance and other departments as it relates to site Quality Assurance responsibilities. Responsible for ensuring compliance with company policies, procedures, and quality standards, as well as safety and environmental regulations. Provides daily support to product review and release functions. Writes and assists others in writing standard operating procedures. Key Responsibilities. Performs or supports activities related to Batch Record Review and Disposition of Raw Material, Bulk, and Finished Product. Performs or supports activities related to SUI Authorization, Reconciliation and Shipping Order Processing. Performs or supports activities related to Material Reconciliation, Material Holds, DO Processing and X-Batch Creation. Performs or supports activities related to APR Contributions for Raw Materials and Finished Goods. Performs or supports activities related to c. MAT and s. MIC creation and workflows. Performs or supports activities related to Maximo QARR Approvals. Performs or supports activities related to design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP’s). Provide support to capturing of site metrics and promote improvement opportunities. Facilitate resolution of issues to improve site metrics. Provides training and direction as needed to new employees. Teams with Department members for process feedback and continuous improvement opportunities. Other Support Functions. Performs or supports Shop Floor activities related to Equipment Status Updates, GMP Walk Throughs, Material Issuance and Line or Area Cleaning Verifications as needed. Provides support to QA Shop Floor including responding to quality events and escalation to management as needed. Provide QA support to various project teams, as needed. Represents Quality Assurance in positive manner. What we are looking for. Required Qualifications. Bachelor's degree in a relevant field or equivalent qualification in Engineering, Science, or a related field. Requires 2-4 Years Pharmaceutical Industry Quality Experience, with proven success in quality systems/compliance improvement within manufacturing or plant operations. Experience with working effectively in a team-based environment. Strong Organizational Skills. Strong Communication/ Interpersonal and Facilitation Skills (verbal, written and presentation)Expertise in Handling Multiple Priorities. Strong experience using the Microsoft Office suite of applications (Word, Excel, PowerPoint)Desired Qualifications 4 years professional experience in a regulated industry. Process and Systems Experience, especially with SOPs, MB - Rs, Change Controls, Non-Conformance Investigation Documentation. Experience with Liquid Dose processing and packaging technology preferred. Familiarity with quality systems, regulations, and business impact. Experience with LIMS, SAP, and EtQ is preferred. What’s in it for you.