Quality Systems Associate
Dollar Tree
The Quality Systems Associate will assist in completing the day to day responsibilities of the Quality Systems Manager. Responsibilities include, but are not limited to, preparing metrics and trending reports, assisting in preparing quality council presentations, recording/tracking of Complaints and Deviation Investigations, recording/tracking Complaint and Deviation Investigation CAPAs, recording/tracking/writing Change Controls, writing reports, assisting with reportable events, and Recalls, writing/revising SOPs, maintaining all master documentation files, recording and maintaining training records, and communicating with the vendors/manufacturers as necessary to ensure the timely completion of required activities.
Principal Duties & ResponsibilitiesWrites, reviews, and revises standard operating procedures and forms as necessary.Assists in the review, approval and issuance of controlled documents including Standard Operating Procedures (SOPs), forms, organizational charts, specifications and other related cGMP documentation.Distributes and notifies departments of document releases, changes, obsolescence of documents and reconciles controlled copies of documents, as applicable.Maintains the document archives and conducts periodic reviews of the record retention system.Oversees the Quality & Compliance Training program and approval of GMP training materials.Enters employee training in the Training System, identifies overdue training, implements training profile updates, and schedules training as required.Maintains/files GMP training records for personnel in a central, accessible, and secure location.Administers and oversees the internal discrepancy/deviation and Corrective and Preventive Actions (CAPA) processes within the organization, including review and approval of applicable records.Administers and oversees the commercial product complaint process, including oversight of third-party complaint handling administrators, as applicable.Communicates with the contract facility/supplier, as warranted, to obtain additional information on Complaints and Deviation Investigations.Tracks closure of Complaint and Deviation Investigations and associated CAPA’s generated by contract facility sites as a result of a complaint or event.Oversees the regulatory notification process (e.g. market actions such as Medical Device Reports) and monitoring and documenting product recalls.Administers and oversees the internal change control system(s). Issues Change Control numbers, updates electronic tracking logs, routes documents for review/approval, and schedules Change Control meetings as required.Monitors quality metrics for trends, patterns, and recurrences. Prepares data, metrics, trending reports, and presentations for monthly Quality Council meetings. Monitors the Quality System for compliance with the Quality System Regulation (QSR) requirements.Notifies the Quality Systems Manager of any trends, patterns, and recurrences.Administers and oversees the Risk Management program.Administers the internal audit program to ensure compliance with policies and control procedures and practices, and regulatory requirements.Prepares the Annual Product Reviews in collaboration with Quality Assurance, suppliers or other third-parties. Tracks Annual Product Reviews prepared by contracted facilities to ensure timely submission and review.Updates/maintains the internal audit schedule and notifies the Quality Systems Manager of any overdue audits. Participates in Internal Audits as required.Tracks CAPAs as a result of an Internal Audit observation/action for completion. Notifies the Quality Systems Manager of overdue CAPAs that are a result of an Internal Audit observation.Maintains the supplier performance metrics, trends data and communicates data to senior management and suppliers, as appropriate.Notifies management of significant quality or compliance issues.Assists in other functions in the department, as needed. Minimum Requirements
Bachelor of Science degree in a science or engineering discipline or 5 years related work experience Minimum 3 years of Quality experience in a highly regulated industry Working knowledge of FDA Quality Systems (cGMP) and/or similar regulatory requirements (21CFR, Parts 111, 210, 211, 700 and 820) and Health Canada. Proficient with Microsoft office applications.Strong attention to detail.Excellent verbal and written communication skills with the ability to interact across function, departments, seniority levels and contract facility management.Ability to work independently guided by documented procedures, with appropriate support.Able to work effectively as part of a team.Ability to explain problems, develop solutions, and make recommendations, and the ability to handle various urgent requests in a professional manner.Effective time management and interpersonal skills.Ability to deliver within established timelines.Working knowledge of statistics preferred.
Preferred Qualifications
Quality Assurance/Systems experience in a highly regulated industry such as pharmaceutical, medical device, cosmetic, children’s product industry preferred.
Principal Duties & ResponsibilitiesWrites, reviews, and revises standard operating procedures and forms as necessary.Assists in the review, approval and issuance of controlled documents including Standard Operating Procedures (SOPs), forms, organizational charts, specifications and other related cGMP documentation.Distributes and notifies departments of document releases, changes, obsolescence of documents and reconciles controlled copies of documents, as applicable.Maintains the document archives and conducts periodic reviews of the record retention system.Oversees the Quality & Compliance Training program and approval of GMP training materials.Enters employee training in the Training System, identifies overdue training, implements training profile updates, and schedules training as required.Maintains/files GMP training records for personnel in a central, accessible, and secure location.Administers and oversees the internal discrepancy/deviation and Corrective and Preventive Actions (CAPA) processes within the organization, including review and approval of applicable records.Administers and oversees the commercial product complaint process, including oversight of third-party complaint handling administrators, as applicable.Communicates with the contract facility/supplier, as warranted, to obtain additional information on Complaints and Deviation Investigations.Tracks closure of Complaint and Deviation Investigations and associated CAPA’s generated by contract facility sites as a result of a complaint or event.Oversees the regulatory notification process (e.g. market actions such as Medical Device Reports) and monitoring and documenting product recalls.Administers and oversees the internal change control system(s). Issues Change Control numbers, updates electronic tracking logs, routes documents for review/approval, and schedules Change Control meetings as required.Monitors quality metrics for trends, patterns, and recurrences. Prepares data, metrics, trending reports, and presentations for monthly Quality Council meetings. Monitors the Quality System for compliance with the Quality System Regulation (QSR) requirements.Notifies the Quality Systems Manager of any trends, patterns, and recurrences.Administers and oversees the Risk Management program.Administers the internal audit program to ensure compliance with policies and control procedures and practices, and regulatory requirements.Prepares the Annual Product Reviews in collaboration with Quality Assurance, suppliers or other third-parties. Tracks Annual Product Reviews prepared by contracted facilities to ensure timely submission and review.Updates/maintains the internal audit schedule and notifies the Quality Systems Manager of any overdue audits. Participates in Internal Audits as required.Tracks CAPAs as a result of an Internal Audit observation/action for completion. Notifies the Quality Systems Manager of overdue CAPAs that are a result of an Internal Audit observation.Maintains the supplier performance metrics, trends data and communicates data to senior management and suppliers, as appropriate.Notifies management of significant quality or compliance issues.Assists in other functions in the department, as needed. Minimum Requirements
Bachelor of Science degree in a science or engineering discipline or 5 years related work experience Minimum 3 years of Quality experience in a highly regulated industry Working knowledge of FDA Quality Systems (cGMP) and/or similar regulatory requirements (21CFR, Parts 111, 210, 211, 700 and 820) and Health Canada. Proficient with Microsoft office applications.Strong attention to detail.Excellent verbal and written communication skills with the ability to interact across function, departments, seniority levels and contract facility management.Ability to work independently guided by documented procedures, with appropriate support.Able to work effectively as part of a team.Ability to explain problems, develop solutions, and make recommendations, and the ability to handle various urgent requests in a professional manner.Effective time management and interpersonal skills.Ability to deliver within established timelines.Working knowledge of statistics preferred.
Preferred Qualifications
Quality Assurance/Systems experience in a highly regulated industry such as pharmaceutical, medical device, cosmetic, children’s product industry preferred.
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