Quality Specialist

PerkinElmer, Inc.; Macclesfield; On-site; GBP 35,000 - 52,000; Full time

Benefits offered by this job

Income protection

Private medical insurance

Pension scheme

Employee & family support

Cycle to work

Job summary

PerkinElmer, Inc. is seeking a highly organised Quality Specialist to join our on-site team in the north of the UK on a 14-month fixed-term contract. The role supports service delivery in compliance with GMP/GLP requirements and our Quality Management System.

You will write technical documentation with SMEs, support inspection readiness, manage CAPA, supplier quality, training, and continuous improvement activities alongside procurement and engineering.

Qualifications

• Experience ensuring GMP/GLP/GCP compliance.
• Strong written and verbal communication skills.
• Understanding of quality management systems and ISO standards.
• Experience with supplier quality management.
• Knowledge of regulatory requirements for pharma/biotech environments.

Responsibilities

• Provide routine support to ensure service delivery complies with quality standards and regulatory requirements.
• Collaborate with SMEs to write technical documentation with high quality content.
• Guide inspection readiness activities and ensure QMS compliance.
• Support deviation, change, event & CAPA processes and timely closure.
• Manage vendor/supplier quality within the site quality program.
• Develop and deliver training programs on quality processes.

Skills

Documentation

Regulatory knowledge

Communication

CAPA & investigations

Quality systems

Education

Bachelor's degree (quality management / related)

Job description

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, for the fixed-term contract (14 months). The role will form part of our on-site Quality team ensuring that our service delivery remains in compliance with our agreed quality commitments and regulatory requirements and quality management system.,

• As part of the onsite team, provides routine support and guidance to ensure service delivery is in compliance to our agreed quality and regulatory standards
• Working with identified SME's, supports with the writing of technical documentation ensuring high quality content and adherence to GMP standards.
• Provides guidance for the inspection readiness program for the site, while ensuring compliance to our scope of work and defined requirements within the QMS and Quality agreement. Inspection readiness may include periodic PerkinElmer or client self-inspections, or any external agency inspections
• Works with the quality team and operations team providing support to the deviation, change, event & root cause investigation processes, ensuring effective and on-time completion of CAPA management.
• Support the vendor management program for the site to ensure adequate supplier compliance, while ensuring adherence to the QMS for the scope of work defined in the SLA and/or Quality Agreement.
• Develop and implement training and education programs, to educate PKI employees and management on quality processes, standards and results
• Support with the development and implementation of an annual quality plan based upon areas for continuous improvement of our quality service.
• 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 quality performance and audit findings to management.
• Support with the delivery of the program quality improvement plan 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, Bachelors degree in quality management, supply chain management or a related field OR
• Minimum of 3 years experience in quality assurance, supplier management, or a related role. OR
• Recognised Quality management related qualification OR
• Strong knowledge of quality standards and methodologies (e.g. ISO 9001, Six sigma, LEAN), Certified quality auditor or similar certification
• Knowledge of regulatory requirements relating to GMP
• 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.
• 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
• 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.
• 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.

Benefits

• Income Protection Insurance that ensures your income is protected when life takes the unexpected turn
• Life Assurance for added peace of mind
• Access to our WeCare Programme, offering medical, mental health, legal, and financial support
• MyStrength - a personalised wellbeing app
• AXA Health & Wellbeing App to help you stay on top of your health
• Private Medical Insurance, including Doctor at Hand for 24/7, 365 access to a GP
• Enhanced company pension contributions (subject to increased employee contribution) to help you plan for the future
• Exclusive discounts via Benefit Hub and BHN Extras
• Generous employee referral rewards
• Season Ticket Loan Scheme to make commuting easier
• Cycle to Work Scheme promoting a healthier, greener commute