The Sr. Quality Associate is responsible for providing support of R&D Quality activities as related to R&D Quality data and documentation surveillance. Additionally, this position will operate as a liaison among the various Quality areas, R&D functions, and Merz Quality entities coordinating on trend analysis. This position works with minimal supervision & requires a very high degree of interaction with other cross functional departments.
Responsibilities
Quality System Document Management:
Generating and/or revising procedural documents and active participation in the SOP Committee.
Processing of all document types and, including Document Change Notices, Marketing Materials, Manufacturing Support documents, Facilities Maintenance documents, Change Requests, Protocols and Reports, etc. through the review/approval process, uploading attachments if needed, and ensuring final document meets the standards for Document Control before release.
Perform SAP transactions governing specification documents.
Liaise with Business Operations regarding procedural document training and associated competency quizzes.
Provide training on the QMS & Document Management to Ax R&D staff as needed.
Quality Data Surveillance Management:
Responsible for the management of Ax R&D Quality data surveillance to include the maintenance of outcomes and documentation for audits, inspections, issue management, procedural documentation, and overall data and documentation for all areas of quality.
Effectively manage data analytics as defined by department, and corporate objectives.
Analyze and present cross functionality on quality outcomes to support decision-making.
Effectively manage project timelines as defined by department, project team, and corporate objectives.
Produce R&D Quality data metrics to support the Quality Data Report and Global Quality Council
Develop and implement strategies and systems for data analyses, data collection systems, and other strategies that optimize statistical efficiency and quality.
Identify, analyze, and interpret trends or patterns in complex data sets as it pertains to Ax R&D.
Inquiry Management:
Responsible for the management of all inquiries received in Ax R&D Quality
Provide updates to R&D Quality staff, as applicable.
Development and implement data analyses, data collection systems and other strategies that optimize statistical efficiency and quality as it pertains to inquiry management.
Vendor Qualification:
Responsible for the management of vendor qualification surveillance activities. Specifically, manage the triage and scheduling of vendor qualifications, manage the global vendor qualification list and vendor qualification questionnaires for all vendors.
Ensuring all vendor qualifications are current.
Escalate qualification noncompliance as needed
General Quality Support:
Provide support for R&D related audits and inspections, both internal and external
Provide support for approval of R&D vendors/suppliers.
Provide support for R&D related SOP creation and maintenance.
Provide support for R&D related Issue Management, including the ownership of NCRs and Action Items
Assist in ensuring applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to applicable regulations (ISO, Ministries of Health (FDA, EMA, Health Canada, TGA, ANVISA, etc.)).
Quality Improvements:
Engage with and promote harmonization initiatives within the R&D group.
Engage with and promote projects to improve R&D compliance and operational efficiencies.
Quality Intelligence:
Stay informed of the latest updates related to applicable regulations to ensure R&D Quality policies and procedures remain compliant.
Provide updates to R&D staff, as applicable.
Further Tasks:
Communicate effectively cross-functionally and raise questions/issues to the attention of executive management, as appropriate.
Provide support to other R&D staff as needed and perform duties and assignments as required.
Other duties as assigned:
Additional duties as needed to support the business and overall company objective
Technical Skill
Initiative and a willingness to go above and beyond expectations
Strong sense of drive, initiative, and self-motivation
Demonstrated proactive approach to the management and oversight of assigned tasks and projects to drive them to successful completion.
Demonstrated organizational skills, ability to independently prioritize work and detail oriented
Effectively manage project timelines as defined by department, project team, and corporate objectives.
Proficient in all MS Office applications
Strong verbal and written communication skills
Ability to effectively multitask and manage multiple projects
Knowledge of regulatory requirements and standards (i.e. GCP, GMP, GLP, Data Integrity)
Ability to work effectively in a global, matrix environment
Ability to travel up to 20%
Minimum Qualifications
Bachelor’s Degree or equivalent experience that demonstrates the ability to perform the duties of this position.
Minimum 5 years relevant Quality document management, data management, and/or analysis experience
Experience with Master Control Quality Management System
Proficient in all MS Office applications
Demonstrated organizational skills, ability to independently prioritize work and detail oriented.
Strong verbal and written communication skills
Ability to effectively multitask and manage multiple projects
Preferred Qualifications
Certification(s) – ASQ Quality Assurance
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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