QA Operations Analyst I

Job description

Job Description

Responsible for completing product attribute and particulate inspections, manufacturing batch record review, line audits, and product sampling to ensure products are manufactured in compliance with corporate, regulatory and industry standards. Functions as primary contact for QA operations team, escalating issues to supervisors as needed. Participates in development and implementation of quality projects and supports department initiatives.

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 adequate QA Operations line inspection coverage to support production schedules.
•Plan and schedule QA work activities based on production schedules, product release needs, and changing priorities.
•Balance line inspection coverage for multiple manufacturing lines by multitasking and prioritizing work load
•Balance line inspection coverage for multiple manufacturing lines by multitasking and prioritizing work load
•Manage on-time completion of monthly PMs Technical – Lead quality assurance activities to ensure products comply with applicable standards. Daily- Ensure that products are manufactured to appropriate cGMP standards by:
•Audit production lots to ensure products manufactured are in compliance with corporate, regulatory and industry standards
•Verify all variable coating prior to initiating production
•Perform Inspection By Attribute testing to detect particulates and/or product defects
•Review non-conformities found during the manufacturing process to assess need for mechanical intervention and/or product hold
•Pull analytical samples for chemistry and microbiological testing
•Pull, log, and inspect retention samples
•Review MBRs to ensure all manufacturing batch procedures are followed and all data is recoded per procedures
•Review and approve autoclave charts for verification of critical parameters and correct load configurations
•Verify entries in inventory/release systems in relation to expiration dating and completed quantities
•Enter and verify test results in Laboratory management system
Posting Title

QA Operations Analyst I

Desired profile

Minimum requirements

• Bachelor’s Degree in a scientific or technical discipline or 8 years applicable work experience
• 1 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

Fort Worth, 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.