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Career Opportunity Job Title:Quality Assurance Specialist IIDepartment:Quality Assurance DepartmentReports To:Director, QADate:July 2020Purpose:Provide customers and TAPEMARK employees with confidence in Tapemark’s quality systems and processes by managing the preventive quality programs outlined below.Key Result Areas:1. Responsible for acting consistently with Tapemark’s core values of Excellence, Responsibility, Integrity, Community, Knowledge and Attitude to ensure the organization’s effectiveness and success.2. Reviews Manufacturing documentation ensuring compliance with cGMP, FDA and EU regulations, ISO 13485, Tapemark procedures and customer requirements.Review manufacturing batch records for operations and quality to ensure regulatory compliance. This will include documentation for all Pharmaceutical and Medical Device products produced at Tapemark. Work closely with operations and quality groups to resolve discrepancies within the manufacturing batch record and guide them in making the appropriate corrections per applicable requirements in a timely and efficient manner to prepare product for final release.Responsible for communicating verbally and in writing with customers to ensure their needs are met during the batch record review process ensuring all questions/concerns are resolved prior to product release. This includes preparing all batch release documentation (Certificate of Analysis, Certificate of Conformance, CGMP Manufacturing Certificate, etc.) and delivering it to the customer for their review and release.3. NCM / CAPA Systems Supports review of Non-Conformance investigation reports for comprehensiveness, accuracy, and compliance to CGMPs and SOPs with efficient monitoring and closure of Non-Conformances and Corrective Actions. Provide joint leadership and support to the Material Review Board, responsible for working with the team to resolve Non-Conformances, Customer Complaints, and CAPA’s in a timely manner. Cross-functional support to Quality, Engineering and Operations on completing investigation and corrective action reports within Tapemark’s NCM/CAPA system.Initiates and writes investigations for Non-Conformances when necessary utilizing effective Root Cause Analysis tools. Appropriate, timely and effective follow-up with Customers and /or internal functions as required.4. Supports all Quality Assurance functions to ensure activities are completed in a timely manner.Back-up other Quality Assurance Specialists and Documentation Specialists as needed issuing batch records, routing document change requests, generating reports, etc.Authors and revises applicable SOPs. Revises manufacturing records as appropriate. Other duties as assigned. 5. Cooperates with co-workers, supervisors, and managers to develop a team environment where individuals work in an effective and productive manner.Fosters a team environment where others are treated professionally and respectfully.Train co-workers on reviewing a variety of batch records. Coach employees on Quality Assurance procedures and expectations of the Quality System along with regulatory municates with co-workers, supervisors, and managers about barriers and solutions in a professional, constructive plies with company policies including those for tardiness and attendance.6. Participates in a variety of projects to meet Tapemark and customer quality piles data and completes the annual Product Quality Review (PQR) report for all commercial pharmaceutical products produced at Tapemark.Participates in determining timetables and scopes of projects.Coordinates and communicates updates to team members.Assists in the evaluation of issues and communicates any recommendations for dispositions. ................
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