Quality Specialist

Concordance Healthcare Solutions Careers•Edison, NJ

23d•Hybrid

About The Position

At Concordance Healthcare Solutions , we believe that each team member makes a difference in driving our purpose of positively impacting lives forward. Concordance is committed to our guiding principles of financial stewardship, accountability, forward thinking, aligned relationships and an inclusive culture. This is done through maintaining an unwavering amount of respect and commitment with our employees and customers, being authentic to who we are and operating with the highest levels of integrity. Through our dedicated staff of over 750 employees, working in strategically-located distribution centers across the country, we offer dynamic supply chain solutions to the entire healthcare continuum. We have a job opening and exciting opportunity for a full-time Quality Specialist in our Edison, NJ location. The primary role of the Quality Specialist is to support the cGMP compliant quality program for pharmaceutical storage. The role will work in collaboration with the Emergency Preparedness and Response Manager, Operations Manager, Program Manager, and Compliance Manager to maintain and enhance the quality management system (MasterControl) and ensure consistent quality practices across all distribution operations. This role ensures adherence to federal and state healthcare regulations, industry standards, and internal policies, while fostering a culture of continuous improvement and operational excellence.

Requirements

Bachelor’s Degree in technical discipline (science or engineering) or related field; or equivalent combination of education and experience.
Minimum of 3 years of experience in quality management at an ISO certified or FDA regulated drug, biologic, or medical device manufacturer or distribution center.
Experience with Master Control Quality Management software or MasterControl is strongly preferred.
Proficient in Microsoft Office, including strong Word, Excel, and Outlook.
Must have excellent communication skills, both written and verbal.
Ability to communicate with individuals at all levels of an organization.
Must have strong math and computer skills.
Must have knowledge using an ISO quality system or cGMP quality system in a storage or distribution facility.
Ability to multi task and be forward thinking.
With the possibility of a work from home hybrid model (in office part of the week and remote part of the week).
Successfully pass a pre-employment (post offer) background check and drug screening.

Responsibilities

Serve as a functional member of the Quality team to manage MasterControl, including document control, training, change control, and other cGMP workflows.
Participate in the development, maintenance, and documentation of policies, procedures, and work instructions within the Quality Management Program.
Schedule, participate in, and review internal quality audits and related meetings.
Support external audits with customers, regulatory bodies, and third-party auditors and track audit findings with assisting in timely implementation and verification of corrective actions.
Serve as the internal point of contact for documenting and tracking ongoing performance issues.
Support root cause analysis efforts to help develop effective corrective and preventive actions (CAPA).
Act as liaison with customers and vendors regarding quality issues, investigations, and corrective actions.
Conduct vendor qualification activities and review annual vendor requalification documentation.
Assist with future validations or revalidations of systems, equipment, or processes.
Verify Preventive Maintenance activities are completed in accordance with contractual agreements.
Collaborate with functional and departmental managers to support new programs and change management of existing processes.
Maintain and enhance the training reference material and training program by ensuring training assignments are current and completed for new hires and existing employees.
Perform additional responsibilities as assigned to support the Quality and Compliance program.
Other duties as assigned.