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Senior Quality Assurance Specialist

2 months ago

Deeside, Flintshire, United Kingdom ConvaTec Full time
Job Title: Senior QC Analyst

Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions. We are seeking a Senior QC Analyst to join our team in a laboratory and clean room environment.

Key Responsibilities:
  • Supervise a team of Chemical Analysts, ensuring the day-to-day operations are conducted as per procedures and schedules.
  • Assist the Laboratory Team Leader in managing the analytical team's workload and objectives.
  • Maintain equipment maintenance and calibration schedules.
  • Provide laboratory support for operations, plan testing schedules to ensure turnaround of release for analytical chemistry.
  • Manage out of specification results, facilitate laboratory investigation reports, and involve the Laboratory Team Leader where applicable.
  • Collect and trend data, react to trends and report to Laboratory Team Leader.
  • Maintain laboratory metrics.
  • Control stock orders and maintain inventory of consumables.
  • Maintain waste disposal in line with EHS guidelines.
  • Utilize the SAP business system to facilitate product release.
  • Ensure compliance is maintained as directed by notified bodies regulations.
  • Compliance with GMP standards and uphold these standards.
  • Compliance with GLP standards and uphold these standards.
  • Responsible for identifying and introducing continuous improvement opportunities within the lab.
  • Support request testing and project work.
  • Perform method validations.
  • Adhere to legal, corporate and site legislation.
  • Maintain validation of analytical chemistry test methods.
  • Ensure maintenance of operational equipment within the lab.
  • Maintain operational equipment within a validated state.
  • Apply knowledge of analytical equipment to perform repairs and preventative maintenance.
  • Collaborating with supply chain and vendors to resolve non-conformances.
  • Support root cause investigations. Liaise with Rhymney Quality Assurance.
Requirements:
  • Successful participation in a quality system in a complex and regulated manufacturing environment.
  • Exposure to data management and interpretation of the data sets.
  • Excellent written skills which have been used to author both technical reports and quality documents (specification and procedural based).
  • Demonstrates working in a fast-paced environment where changes are embraced and implemented. An enthusiastic individual who drives, initiates, and implements new initiatives for the overall benefit of the working environment.
  • Knowledge of ISO standards and FDA regulations.
  • Knowledge of continuous improvement / quality assurance methods and techniques.
  • Coaching and mentoring of laboratory technicians.
Qualifications/Education:
  • Educated to degree level, or equivalent, within Chemistry discipline.
  • At least 2 years' experience within an Analytical Chemistry laboratory.
  • Experience of ISO13485 and Pharmacopeia's references.
  • Understanding of GMP and Quality Systems in a regulated environment.
  • In-depth knowledge of HPLC, ICP-MS, GC-FID and AAS.
Travel Requirements:
  • No
Languages:
  • Speaking: Yes, English
  • Writing/Reading: Yes, English
Working Conditions:

Working in a laboratory and clean room environment, as well as in an office, from 9:00 to 16:30 Monday to Friday. Each shift should include one 30-minute break starting between 12:00 and 12:30, which can be shifted slightly depending on laboratory practicality. Must be available outside of work to support chemical analysts.

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.