Quality Assurance Manager

Overview

Quality Assurance Manager - 1st Shift, Monday through Friday, in office, 8am-5pm with schedule flexibility

This position is responsible for establishing, implementing and maintaining a Quality Assurance System that ensures how the activities of the Company comply with various regulatory standards (U.S. and International). This position is responsible to manage and review non-conformances, conduct investigations, implement and codify corrective and preventive actions and systems in a collaborative manner. Also, the position is responsible to review and audit established product flow controls.

• Manages and reviews non-conformances, corrective actions, preventive actions, and deviation system.
• Assists with Batch Record and Documentation review and approval.
• Performs online auditing functions when needed.
• Performs batch record releases as needed.
• Assists in leading the Quality group in identifying and anticipating trends in quality issues and collaborating with other units to ensure risk-managed solutions are implemented in a timely fashion.
• Provides support on initiatives involving systems, processes, procedures, regulations and tools intended for the manufacture of Company products.
• Acts as a lead for online production based Quality issues and initiatives.
• Challenges and influences compliance routines and systems to ensure full regulatory compliance.
• Provides regular updates to leadership and participates in the resolution of online and production-based issues.
• Participates in quality and compliance initiatives, as assigned.
• Ensures procedures are developed and implemented to provide proper control of product flow.
• Leads process for failure investigation and resolution of complaints and non-conformances relative to product manufacture, storage and distribution of products.
• Utilizes metrics to drive continuous improvement in the areas of cost, compliance and quality.
• Assists in preparing the Company for participation in and oversight of on-site regulatory, customer and third-party audits.
• Communicates to various internal departments on critical cGMP and/or non-compliance issues in a timely manner.
• Stays current with regulatory guidance. Informs leadership team and internal groups of changes and Company impact.
• Contributes to the leadership team and engages in business decision making from a compliance perspective.
• Promote a safe and harmonious work environment.
• Maintain compliance with SOPs, GMPs, and all company policies.
• Review product labeling for compliance with regulations; analyze and recommend appropriate changes.
• Other duties as assigned or required.

• A Bachelor’s degree from a regionally accredited institution in science or related field
• At least 5 years’ experience in a quality assurance role of a quality group in a pharmaceutical or medical device setting
• Experience in CAPA and/or batch release systems
• Experience in aseptic product flow
• Knowledge of general computer functions such as Microsoft Office programs, spreadsheets, etc.
• Knowledge and understanding of processes relevant to quality and compliance of the manufacturing and production of regulated products, regulatory and development processes, how regulatory entities approach inspections, responding to regulatory observations, regulatory cGMP requirements for pharmaceuticals, regulatory approval processes, cGMPs and SOPs, regulatory entity inspections requirements, regulatory guidance documents
• Knowledge of Federal and State OSHA and environmental regulations and practices
• Knowledge of contemporary instructional design techniques to assist in training/coursework design
• Skill in handling several projects or tasks at the same time, or within a given time frame
• Advanced Problem Safety Sensitivity; the ability to recognize a safety issue or potential safety issue
• Skill to use time management techniques in personal daily tasks and that of others
• Skill in quality and compliance vigilance
• Ability to inspect the work of others and coach performance in line with company standard operating procedures
• Ability to apply critical thinking
• Advanced interpersonal and communication skills
• Ability to develop a quality compliance…