Quality Coordinator (Hybrid position)

Concordance Healthcare Solutions LLC; Edison (NJ); Hybrid; USD 60,000 - 80,000; Full time

Benefits offered by this job

Health, Life, Dental, Vision Insurance

Paid Vacation and Personal time

401K Retirement Plan – Company match

Company paid Short Term & Long Term Disability

Profit Sharing Program

Job summary

Concordance Healthcare Solutions LLC is seeking a Quality Coordinator to support cGMP compliant quality programs at our Edison, NJ location. This full-time role will involve managing MasterControl for quality management while collaborating closely with various managers to ensure quality practices across operations.

The ideal candidate should have a Bachelor’s Degree, at least 3 years of experience in quality management, and proficiency in Microsoft Office. Benefits include health insurance and a 401K retirement plan.

Qualifications

• Minimum of 3 years of experience in quality management at an ISO certified or FDA regulated facility.
• Strong preference for experience with Master Control Quality Management software.
• Proficient in Microsoft Office, especially Word, Excel, and Outlook.

Responsibilities

• Manage MasterControl including document control and training.
• Participate in the development of policies and procedures.
• Schedule and review internal quality audits.

Skills

Communication skills

Microsoft Office proficiency

Multi-tasking

Mathematical skills

Education

Bachelor's Degree in a technical discipline

Tools

MasterControl Quality Management software

Job description

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 (MasterControl) and ensure consistent quality practices across all distribution operations.

Essential Functions

• 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 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.

Qualifications

• 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 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.
• 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.

Work Location

• This role is located in Edison, NJ.

Benefits

• 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.