Macclesfield United Kingdom

Responsibilities

Location Macclesfield, CheshireGB Job ID REQ-053244

The Company

PerkinElmer is a global analytical services and solutions provider with offerings including the leading OneSource Field and Laboratory services business that serve the biopharma, food, environmental, safety and applied end markets to accelerate scientific outcomes. Since 1937, PerkinElmer has served as a trusted partner in laboratory analysis and management and today complements its service offerings with a broad portfolio of atomic spectroscopy, molecular spectroscopy, and chromatography instruments, consumables, and reagents. With a dedicated team of more than 5,000 team members, the Company serves customers in more than 35 countries. Additional information is available at www.perkinelmer.com

Purpose

We are seeking a highly organised & detail orientated Quality Specialist to join our team based on a customer site in the north of the UK. The role will oversee the supplier management aspects of our quality management system, ensuring that where suppliers are selected to deliver service, their cGXP quality standards meet & exceed the requirements of our customer.

Responsibilities:

• Collaborate with procurement and other relevant departments to ensure a seamless onboarding process for new suppliers, in adherence with customer and company standards.

• Review and assess supplier documentation, certifications and compliance records.

• Maintain accurate records of supplier qualifications and performance metrics.

• Conduct on-site and remote supplier audits to evaluate compliance with quality standards.

• Stay updated on industry standards and best practices related to supplier quality management.

• Work closely with procurement, engineering and other departments to ensure supplier-related quality issues are addressed promptly.

• Participate in cross functional teams to drive quality improvement initiatives.

• Prepare and present reports on supplier quality performance and audit findings to management.

• Support with the management of deviation, change management and other supplier quality related activities across the program.

• Support with inspection readiness program for the site, while ensuring compliance with the QMS for the scope of work defined in the SLA and/or Quality Agreement. Inspection readiness may include periodic PerkinElmer or client self-inspections, or any external agency inspections.

• Support with the delivery of the program quality improvement plan

Critical Skills:

• Excellent analytical, problem-solving, and organisational skills.

• Strong communication and interpersonal skills

• Strong understanding of Good Documentation Practices

• Understanding of regulations governing GMP/GLP/GCP activities

Basic Qualifications:

• Bachelors degree in quality management, supply chain management or a related field OR

• Minimum of 5 years experience in quality assurance, supplier management, or a related role. OR

• Recognised Quality management related qualification

• Strong knowledge of quality standards and methodologies (e.g. ISO 9001, Six sigma, LEAN)

Preferred Qualifications:

• Certified quality auditor or similar certification

• Knowledge of regulatory requirements relating to supplier management

• Experience of working within Pharma

Working Environment:

• Role is site based on a customer site

• Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.) in laboratory.

• Job pace may be fast and job completion demands may be high.

• Must be able to remain in a stationary position more than 25% of the time

• The person needs to occasionally move between labs, corridors, adjoining rooms, and buildings onsite Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.

• Specific vision abilities required by this position include without limitation, the ability to observe details at close range distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.

• Operates a computer and other office machinery, such as a calculator, copy machine, and computer printer.

• May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator as protection against hazards present in the laboratory environment.

PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.