Sr Associate, QA

Baxter International; Stockport; On-site; GBP 35,000 - 45,000; Full time

Job summary

A leading healthcare company in Stockport is seeking a Quality Assurance Specialist for their night shift. The role includes managing compliance with quality systems, validating equipment, and ensuring product safety. The ideal candidate should have at least 2 years of experience in aseptic compounding operations and quality system implementation. This position offers professional development opportunities and emphasizes work-life balance.

Benefits

Competitive total compensation package

Professional development opportunities

Work-life balance

Inclusive and diverse workforce

Qualifications

• 2 years’ experience in an aseptic compounding operation.
• 12 months experience in quality system implementation.
• Ideally, the experience includes quality system management and implementation.

Responsibilities

• Ensure compliance with the Baxter quality system.
• Manage corrective and preventive actions using TrackWise software.
• Perform validation of equipment and processes.
• Investigate out of limit results.

Skills

Experience in aseptic compounding operation

Quality system management

Environmental microbiological control

Validation

Job description

Overview

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Summary

4 Day nightshift, 10pm to 8am, Monday night to Friday morning. Works closely with manufacturing staff on a night-shift to ensure the unit meets customer expectations on delivery and product quality. Responsible for release of product from the system on the night-shift. Responsible for supporting production in the review operations. Responsible for implementation and management of the Baxter quality system within the compound unit, ensuring regulatory compliance. Ensure that the unit is compliant with all corporate quality system policies and procedures. Responsible for reviewing the implementation of the Baxter Quality System to initiate and drive continuous improvement.

Role Responsibilities

• Post Compounding check and Release
• Review of prescriptions on Merlin
• Release activities associated with products manufactured at the compounding units
• Validation: Management of the site Validation Master Plan
• Ensuring all equipment used for the manufacture and storage of product is validated before use
• Ensuring all equipment used for the manufacture and storage of product is re-validated as required per the validation master plan
• GMP and Facilities and Equipment Control: Ensure that a schedule of environmental monitoring is in place that complies with GMP and that any out of limits or alerts are investigated and actions taken to correct
• Responsible for ensuring the schedule of microbiological monitoring ensures the product is safe to use, including ensuring a schedule and facility map are in place and that all testing is complete
• Investigation of out of limits results using exception and CAPA processes
• Ensuring all measuring equipment that may have an impact on product quality are calibrated to traceable standards
• Quality System Measurement and Review: Ensure outcomes, decisions and actions of the review are documented; ensure meeting actions are completed to agreed deadlines
• Track and trend on a monthly basis quality system data and indicators, including but not limited to Exceptions, Errors and Complaints; Trending should include timeliness in completion as well as actual numbers
• Complaints: Ensure all incidents reported by customers are appropriately documented and investigated; manage complaints using Track Wise; report any complaints that may result in Field Corrective Action to the Business management representative and the European FCA gatekeeper; report any adverse events to Pharmacovigilance and the Business management representative
• Exceptions: Ensure that any failure to follow procedure or failure of product to meet specification is fully documented and investigated; review and approval of exception reports; lead and coordinate investigations in the cause of exceptions
• Corrective and Preventative Action: Monitor all quality system processes to detect need for improvements; manage the CAPA system using TrackWise software; CAPA owner and leader; ensure CAPA investigations are completed and root cause identified and that appropriate actions are specified and completed within agreed time frames; raise supplier corrective actions to address out of specification raw material issues; manage Supplier Corrective Action using TrackWise software
• Communication and Training: regularly communicates with all site staff regarding quality issues and promotes the quality system as a business process for improvement of customer satisfaction and regulatory compliance; ensure staff understand their responsibilities under the quality system regulations; communicate changes of the quality system to staff, ensuring appropriate training programs are executed
• Document and Data Management: ensure all procedures are controlled and current versions are available to staff as required; ensure there are no unauthorized changes to documents including creation of local documentation; ensure all quality records are reviewed and that they are complete, comprehensive and legible and comply with good documentation practice; ensure quality records are retained so they remain complete, comprehensive and legible

Qualifications

• Breadth & Depth of experience: 2 years’ experience of working in an aseptic compounding operation
• 12 months experience of quality system implementation
• Field of expertise: Ideally experience in all or any of the following: Quality system management and implementation; Environmental / microbiological control; Validation

Benefits

• Competitive total compensation package
• Professional development opportunities
• High importance placed on work life balance
• Commitment to growing and developing an inclusive and diverse workforce

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Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

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