Associate I, R&D Quality Systems (QMS)

The R&D Quality Management System (QMS) Administration personnel is a QA function responsible for ensuring the QMS systems of training and document control are maintained audit-ready to FDA and ISO requirements, as well as corporate policies and local procedures where established. The role provides administrative support for training and document control activities and instructs users to ensure efficient administration of the systems.

Direct R&D QMS Support

• Write new SOPs and Training Materials to support R&D and QMS activities where requested. Establishes and maintains local SOPs/Forms, and Training Materials where needed.
• Assist R&D personnel with technical writing support for QMS documentation, such as nonconformance investigations and corrective action records.
• Primary AGS SME for the R&D QMS systems of Document Control and Training for supporting R&D External and Internal Audits.

Training Administration

• Generate training plans in the Learning Management System (LMS) to meet functional needs of R&D. Process training plan assignments ensuring job specific and core training requirements are met.
• Will support change control and continuous improvements activities for the training system, as needed.
• Conduct regular training/skill building/practice sharing activities to help the R&D sites: simplify training plans, perform efficient data entry/traceability of training, and quickly assess training system impact and plan out change control tasks associated with training.
• Oversee tracking, trending, and reporting compliance metrics for the Training system: Alcon Scorecard, Management Review, workload volumes and various notifications. Participate in routine meetings with Alcon R&D QMS site staff to communicate metrics.
• Initiates and Oversees the annual periodic review process and continuous improvement activities for R&D training items within the LMS.
• Ensures routine notifications to R&D management personnel are provided for past due and pending training assignments within the LMS.

Document Control Administration

• Generate and Processes changes/documents in accordance with established governing policies and procedures.
• Performs QA approvals for: Document obsolescence (when accompanied by an approved change request), New/revised Work Instructions, Administrative Document Revisions, and Administrative approvals as defined by procedure.
• Auditing of changes/documents ensuring proper resolution of noted deficiencies.
• Acts as a Quality Assurance SME for the document control processes and assists with driving initiatives to identify and solve procedural deficiencies to improve productivity and compliance.
• Lead QMS and compliance project/ initiatives related to Document Control, as requested

Skills Required
Document Control, Dms, Lms, training administration