QA Analyst II, Product Release

Job description

Job Description

Responsible for the batch release process to ensure all applicable quality standards and product specifications are met prior to release, ensures the batch release process is managed in compliance with corporate, regulatory and industry standards, works with production and material issuance departments to facilitate on time batch release, and maintains product holds for potentially non-conforming product.

Safety/Housekeeping – Ensure work areas comply with applicable standards (HSE, GMP, etc.), and that associates are working safely.
•Promote/reinforce company and department HSE standards through regular communication, training, and reminders.
•Ensure associates work according to established standards and SOPs; engage associates to adjust behaviors as needed.
•Ensure work areas are clean and safe, and audit-ready at all times.
•Continuously monitor work areas; identify, resolve, and report safety hazards.
•Ensure materials are handled and disposed of properly, per HSE standards.
•Participate in site safety programs

Planning – Ensure release due report is accurate and updated.
•Plan and schedule meetings with both business units to monitor backlog and prioritize lots with the highest priorities..
•Ensure communication with production daily so that corrections are resolved in a timely manner.
•Manage communication with affiliate QA in order for COA to be pulled and submitted accurately and efficiently.
•Manage on-time completion of monthly review of unreleased product

Technical – Product release and holds in multiple quality, planning, and transaction based systems.

Daily - Ensure that products are manufactured to appropriate cGMP standards by:
•Review DHR checklist to ensure all manufacturing batch procedures are followed and all data is recoded per procedures
•Review non-routine holds on product to verify all release criteria are met
•Review protocols to ensure all validation criteria are met including prototype work orders
•Review and approve sterilization (Ethylene Oxide and Gamma) records for verification of critical parameters and correct load configurations
•Verify entries in inventory/release systems in relation to expiration dating and completed quantities
•Approve release of subassembly work orders for further processing either in house or at 3rd party facilities including prototype work orders
•Coordinate the release of DHR’s (Device History Record) to ensure that all applicable standards and product specifications are met
•Coordinate and process Certificate of Analysis, Certificate of Sterility, Certificate of Conformance and Certificate of Origin for specific country
•Coordinate and prioritize the release of DHRs to ensure stock out situations are avoided
•Prepare batch record paperwork for records retention
•Investigate and add post market holds
•Verify and close out aggregated serialized lots in appropriate systems

Additionally - Contributes to group operational effectiveness by:
•Performing and reviewing SOP/document changes
•Collecting and submitting quality data metrics
•Leading and/or supporting QA Operations projects
•Leading and/or supporting the implementation of corrective and preventative actions
•Participating in deviation investigations and nonconformance review and approval
•Lead validation projects for electronic Quality Systems

Team – Coordinates with and works alongside QA operations technicians, production supervisors, and planning departments ensure timely release of product, control of non-conforming products, and release of batches meeting all manufacturing and regulatory requirements.
•Lead team in problem solving related to product deviations
•Work cohesively with team
•Demonstrate overtime flexibility for production needs
•Act as a role model for company Values and Behaviors
•Planning, overseeing and/or performing the onboarding and training of QA Operations members

Interfaces – Coordinate with and support other departments to ensure smooth execution of work.
•Daily communication of product release status & outstanding items for reporting.
•Hold weekly meetings with production and planning teams to discuss and prioritize backlog
Posting Title

QA Analyst II, Product Release

Desired profile

Minimum requirements

Required:
•Bachelor's degree in scientific or technical discipline or High School Diploma with 8 years applicable work experience.
•The ability to fluently read, write, understand, and communicate in English.
•No prior experience required.

Preferred:
• Minimum 2 years experience in QA, Technical Operations, and/or manufacturing in GMP regulated environment.
•Knowledge in the application of problem solving tools, continuous improvement tools and aseptic knowledge.
•Communicate effectively with all levels of the organization.
•Ability to lead teams for problem solving or continuous improvement.
•ASQ Certified Quality Engineer
Job Type

Full Time
Country

USA
Work Location

Houston, TX
Functional Area

Quality
Division

ALCON
Business Unit

QUALITY ASSURANCE AL
Employment Type

Regular
Company/Legal Entity

Alcon Research, Ltd.
EEO Statement

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.