Job Description

Quality Systems Associate

The Quality Systems Associate will assist in completing the day to day responsibilities of the Quality Systems Manager.

Principal Duties & Responsibilities

• Writes, 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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