Quality Coordinator; Hybrid 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. 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 an exciting opportunity for a full‑time Quality Coordinator in our Edison, NJ location. The primary role is to support the cGMP compliant quality program for pharmaceutical storage and to 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 (Master Control) and ensure consistent quality practices across all distribution operations.

• Serve as a functional member of the Quality team to manage Master Control, 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 while 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.

• Bachelor's Degree in a 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 Master Control 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.
• 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.

• This role is located in Edison, NJ
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• Health, Life, Dental, Vision Insurance
• Paid Vacation and Personal time, Paid Holiday
• 401K Retirement Plan – Company match
• Company paid Short Term & Long Term Disability
• Profit Sharing Program

Concordance Healthcare Solutions is proud to provide Equal Employment Opportunities to all individuals for employment and prohibits any kind of discrimination on the basis of race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, or any other characteristic protected by federal, state or local laws. Consistent with the Americans with Disabilities Act, our organization is committed to providing reasonable accommodation to qualified applicants and employees as requested.