Quality Coordinator; Hybrid position

Concordance Healthcare Solutions is hiring a full‑time Quality Coordinator in Edison, NJ. The primary role is to support the cGMP‑compliant quality program for pharmaceutical storage.

• 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 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.

• 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.
• Excellent communication skills, both written and verbal. Ability to communicate with individuals at all levels of an organization.
• Strong math and computer skills.
• Knowledge of an ISO quality system or cGMP quality system in a storage or distribution facility.
• Ability to multi‑task and be forward‑thinking.
• Work‑from‑home hybrid model possible (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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• Paid Vacation and Personal Time, Paid Holiday
• 401(k) Retirement Plan – Company match
• Company‑paid Short‑Term & Long‑Term Disability
• Profit Sharing Program

Concordance Healthcare Solutions is an Equal Employment Opportunity Employer. We prohibit discrimination based on 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, the organization is committed to providing reasonable accommodation to qualified applicants and employees as requested. If accommodation is necessary for the interview process, please contact