Quality Specialist

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring.
Our solutions provide a range of benefits, from infection prevention and protection of atrisk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC).
To learn more about Convatec, please visit http://www.convatecgroup.com
Change is everywhere at Convatec. It’s transforming our business, and helping us improve millions of lives. And we’re nowhere near finished. Across every part of our business, we’re pushing for better. Join us on our journey to #ForeverCaring as a Quality Specialist and you’ll do the same!

The QA Specialist is an exciting role and will work closely with Operations and Supply Chain teams for QA related activities.

The QA aspects of the role will primarily involve timely approval of raw materials and intermediate products, management of non-conforming materials, environmental monitoring, GMP compliance, and supports to validation and risk management activities as well as drives improvement of QA processes (e.g. via NC/CAPA/RCA).

Key Responsibilities:

• Ensures the timely approval of intermediate products as part of the batch release process as well as raw materials for manufacturing.
• Responsible for proper management (hold, decision making, release) of OOS raw materials and intermediate products in collaboration with Lab, Manufacturing, Supply Chain, and other relevant stakeholders including supplier for raw materials.
• Manages the routine material review board (MRB) including sending out status report (progress) and escalation to relevant stakeholders when required in collaboration with Supply Chain.
• Performs environmental control and monitoring sampling as per routine schedule e.g. cleanroom settle plates, Purified Water samples. Manages the results and coordinates/manages CA/PA as well as investigations against environmental monitoring issues.
• Conducts process, product, and GMP audits to verify compliance with critical GMP requirements. Provides status reports to relevant stakeholder as well management of issue raised via NC/CAPA.
• Conducts GMP training during employee inductions and when necessary e.g. refresher.
• Drives improvement initiatives related to raw materials, intermediate products, GMP practices, environmental control & monitoring.
• Participate/supports generation of new and review of current process risk assessment e.g. pFMEA
• Supports Validation execution and related activities e.g. OQ/PQ, NSPR.
• Work collaboratively with manufacturing to provide support, guidance and coaching to assure compliance with internal QA procedures and instructions.
• Improve and drive performance of quality system processes in order to meet quality and site KPI’s.
• Supports compliance with and maintenance of quality system documentation in line with regulatory standards including ISO 13485, 21 CFR Part 820.
• Support the internal quality audit schedule and execute the audits in accordance with the schedule. Produce clear and concise audit reports and enter non-conformances into the CAPA system.
• Provides cover for Quality Engineer or Quality Systems Engineer when necessary e.g. holidays

Skills & Experience:

• Knowledge of ISO standards and FDA regulations
• Successful participation in a quality system in a complex and regulated manufacturing environment.
• Experience with Change Control and Document Control in A regulated environment.
• Internal Quality Auditing for ISO 9001 / 13485 preferred
• Competent in business standard systems e.g. SAP, eDMS, eQMS (NC, CAPA)
• Knowledge of Cleaning validation preferred
• Excellent written skills which have been used to author both technical reports and quality documents (specification and procedural based).
• Six Sigma Green Belt qualification preferred
• Use of Statistical software preferred
• Process Validation (IQ, OQ, PQ, DoE) preferred
• Competent in generation/principle of Risk Management (pFMEA) preferred

Qualifications/Education:

• Educated to degree level or equivalent preferred

• Understanding of GMP and Quality Systems in a Cleanroom Environment

• Experience of regulatory standards including ISO 13485, 21 CFR Part 820.

Principal Contacts & Purpose of Contact

• Internal – Manufacturing, Quality, Supply Chain, CI

• External – Ad hoc contacts only e.g. bsi audit

Travel Requirements

• Yes - Limited travel expected – Occasional audit support

Languages

• Speaking: English

• Writing/Reading: English

Working Conditions

• Based in the office environment with time spent on the manufacturing floor.

Our transformation will change your career. For good.

You’ll be pushed to think bigger and aim for excellence. Your ideas will be 
heard, and you’ll be supported to bring them to life.

There’ll be challenges. But, stretch yourself and embrace the opportunities, and 
you could make your biggest impact yet. 
This is stepping outside of your comfort zone. 
This is work that’ll move you.

#LI-DS4

#LI-Onsite

Beware of scams online or from individuals claiming to represent Convatec

A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.

If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at [email protected].

Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives

Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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