Quality Control Testing PositionPOSITION PURPOSE: Conduct Quality Control testing of materials and production samples as required to support contact lens production, performing assigned tasks according to approved SOP's, methods, and procedures with adherence to cGMP, FDA, and Corporate Quality policies and regulations. Perform routine and non-routine incoming inspection procedures in generating information for the release of materials for production use, as well as to communicate the disposition of materials to internal and external customers (with minimal supervisory or designee direction). This position also assists in the solution of technical problems, with defined scope.
A typical day will include:
Conduct testing of raw materials, in-process, formulation, and finished product samples in support of Alcon production.
Maintain Analytical Laboratory in compliance with regulatory standards and site procedures.
Document and Review Analytical Data and Laboratory records accurately, timely, completely.
Conduct lab investigations, and special analytical and Incoming Inspections projects as assigned.
Complete and participate in training activities as assigned and to perform job responsibilities and maintain up to date analytical and incoming inspection skill sets and practices.
Participate in continuous improvement activities looking to pursue laboratory best practice and offer appropriate feedback when nonvalue added activities are observed.
Performs key routine procedures with supervisory direction, according to established SOP's, including: Obtaining package material samples and performing the required inspection/testing. Obtaining and preparing raw material samples for testing and submitting to required test area. Disposition materials in SAP and label materials as required. Prepares reports, e-mails and memos to a targeted audience (internally/externally) defined by the supervisor. Correspondence is approved by the supervisor prior to sending, such as: Quality Reports (QR), E-mail notifications of material dispositions, Non-Conformance Reports (Client), Memos.
Performs key non-routine procedures with supervisory direction, including: Protocols, Validations, R & R Studies, Special Projects (new site support & vendor support). Assists with administering laboratory systems, including: Lab safety, Calibration, Documentation (QR, Re-tests, Data Trending, Client), File Maintenance and Lab Inventory maintenance. Assumes responsibility for maintaining required training on SOP's, Safety, GMP. Receives and provides cross-training within the Analytical and Incoming Inspection laboratory on required procedures.
This is a 12-hour shift position. The candidate needs to be able to work 12-hour shifts.
WHAT YOU'LL BRING TO ALCON:Bachelors' Degree in Scientific Discipline; Preferred Level: BS in Chemistry discipline
The ability to fluently read, write, understand and communicate in English 1-2 years of relevant experiencePREFERRED QUALIFICATIONS/SKILLS/EXPERIENCE:Computer Skills with working knowledge of MS Word and MS Excel. Excellent written and verbal communication and interpersonal skills. Excellent problem-solving skills including experience independently writing technical investigations that include a root cause and a corrective action, e.g., nonconformance reports and corrective action reports. Comprehend and follows detailed written and oral instructions and perform moderately complex mathematical calculations (average, percentages, and ranges). Compliance requirements - Must be able to work independently, demonstrate dependable performance under stressful conditions and possess excellent documentation and organizational skills. Knowledge of the following regulations and standards: ISO13485, MDSAP, EU MDR/MDD, and Good Manufacturing Practices (GMP). Experience in SAP, MDLIMS, EMPOWER and TRACKWISE is a plus.
