Overview
Location: Southampton, Hampshire, United Kingdom (onsite). Job title: QA Laboratories Manager. Department: Quality Assurance. Location details: Hamble, Southampton, UK. Working Hours: Mon – Fri, 37.5 hours per week.
A brighter future awaits you. CooperVision is a leading manufacturer of soft contact lenses with a presence in over 100 countries. We’re focused on improving how people see each day and delivering products that enable freedom and confidence for lens wearers.
Scope: Reporting directly to the Director QA/RC, the QA Laboratories Manager shall manage a team and ensure that all microbiological testing, autoclave validations, and materials testing are performed in accordance with Standard Operating Procedures and are compliant with applicable medical device regulations and ISO standards. This role partners with manufacturing to mitigate risk and ensure timely actions to release safe and compliant products.
Responsibilities
* Manage the QA Laboratories departments of Microbiology, Autoclave, and Materials testing.
* Ensure all incoming materials are tested and accepted in accordance with specifications and medical device regulations and standards including ISO 13485, MDD, MDR, FDA QSR.
* Train Microbiology laboratory technicians, ensure safety procedures are followed, and that required training is completed and recorded timely.
* Organize workload to support routine monitoring and non-routine work for Business Unit Projects.
* Validate test methods used in the laboratory and for microbiologically related procedures such as disinfection effectiveness.
* Act as process owner for QA Laboratories and Microbiology to support external audits by notified bodies and health authorities.
* Process and approve Materials and Microbiology data to support production and release targets.
* Lead and participate in Engineering Change Control (ECO) planning and execution. Provide support to Business Unit projects with risk assessments and engineering studies.
* Lead and participate in Risk Management teams.
* CAPA/NCR: lead CAPA investigations, complete investigation reports, implement Corrections, Corrective Actions and Preventive Actions as appropriate; raise NCRs as required and ensure correct product disposition.
* Understand and apply Six Sigma methodology and participate in Six Sigma improvement projects.
* Use aseptic technique for sampling of water, solution systems and un-autoclaved lenses; test for bioburden.
* Test and record results, maintain trend analysis; perform environmental monitoring (settle plates, air sampling, personnel monitoring in wet production areas) and review results for microbiological concerns.
* Identify isolates as required and review autoclave validation reports for compliance.
* Train personnel in GMP and Introduction to Microbiology for ASECs and sterilisation theory training in the absence of the Autoclave Validation Specialist.
* Set departmental budget and reforecast as needed.
* Other duties related to the Company’s business.
Qualifications and Experience
* Minimum five years in the contact lens or medical device industry.
* Minimum of ten years in a Microbiology Laboratory setting.
* Experience in medical device industry, group direct reporting, and laboratory investigations.
* Experience with laboratory equipment (HPLC, GC, TOC, IR, UV, incubators, autoclave, air sampler, etc.).
* Experience in Quality Systems audits.
* Minimum seven years in a management/supervisory role.
* Bachelor of Science degree in Microbiology or Biological Sciences or related discipline with proven Microbiology background in Medical Device sector.
Work Environment
The role operates primarily in an office environment but requires access to Areas of Specified Environmental Cleanliness (ASEC) to assess processes and changes, and to the Microbiology Laboratory when covering for technicians.
Travel
Local travel between UK sites as required. International travel to other CooperVision sites is expected but typically not more than 5% (approximately 3 weeks per year).
What We Offer
* Competitive compensation and a benefits package including bonus, private medical insurance, 25 days holiday, pension scheme, wellness platform, and a discounted contact lens scheme.
* Commitment to personal and professional development with extensive training and access to LinkedIn Learning.
How to Apply
If you like what you see, apply today. All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.
* Locations Ensign Way, Southampton, Hampshire, SO31 4RF, GB (On site)
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