Senior QA Chemist (Quality Assurance Specialist)

Carbogen Amcis; Manchester; On-site; GBP 50,000 - 75,000; Full time

Benefits offered by this job

6% employer pension

Free parking

On-site gym

Private health insurance

Life insurance

Travel insurance discounts

Discount vouchers

Salary sacrifice options (Mintago)

Employee Assistance Programme (EAP)

Job summary

Carbogen Amcis in Manchester is seeking a Senior QA Chemist to provide hands-on quality assurance support across our site. You will help ensure materials, products and processes conform to quality and regulatory standards, driving continuous improvement and a strong quality culture.

The role requires five years of QA experience in regulated manufacturing, a degree in chemistry or pharmaceutical science, and thorough knowledge of the Quality Management System and GMP.

Qualifications

• Approximately five years’ QA experience in chemical manufacturing or regulated environments.
• Degree or equivalent in chemistry, pharmaceutical science or related field.
• Experience planning for internal, external, customer or supplier audits (internal preferred).
• Strong practical experience with Quality Management System and GMP/regulatory standards.
• Ability to assess quality and compliance risks and make evidence-based decisions.

Responsibilities

• Provide QA support across the site to ensure materials, products and processes meet quality and regulatory requirements.
• Lead or support investigations into deviations and CAPAs; coordinate action tracking and effectiveness checks.
• Review batch records, specifications and quality documentation for release.
• Maintain and update controlled documents (SOPs, policies, work instructions).
• Help maintain QA Agreements with customers and suppliers and support internal audits.

Skills

Quality Assurance

Audits

CAPA

Documentation control

Deviations investigations

Education

Bachelor's degree in chemistry or pharmaceutical science

Tools

QA systems

CAPA tools

Job description

Senior QA Chemist (Quality Assurance Specialist)

full-time

Join a team where quality, science and innovation come together.

Are you an experienced Quality Assurance professional looking for the opportunity to take greater ownership and make a visible impact?We are seeking a proactive and knowledgeable Senior QA Chemist to help maintain and continually improve the standards that underpin the quality, safety and compliance of our products and services.

Based at our Manchester site, you will play a senior, hands-on role within the Quality Assurance team. You will support compliance with BS EN ISO 22716 Cosmetics Good Manufacturing Practice, our Quality Management System and Company standards, working closely with colleagues across Quality,

SHE, Production, Process Research and Development, Engineering and other support functions. From audit readiness and product release to investigations, CAPA and document control, you will help ensure that quality requirements are understood, embedded and consistently applied across the site.

This is an excellent opportunity for an experienced QA professional who enjoys combining technical knowledge with practical problem-solving, cross-functional collaboration and continuous improvement. You will contribute to a diverse range of manufacturing, development and customer projects, with the opportunity to become a recognised subject matter expert within an international organisation.

What you'll be doing

As Senior QA Chemist, you will provide practical quality assurance support and guidance across the site, helping to ensure that materials, products, processes and services consistently meet applicable quality and compliance requirements. You will work closely with colleagues across the business, using your judgement and technical expertise to identify risk, resolve quality issues and promote a strong, positive quality culture.

You will manage a varied workload in a highly regulated, yet collaborative manufacturing environment, balancing planned quality-system activities with emerging operational priorities. You will be expected to take ownership of assigned activities, communicate quality risks clearly, and support colleagues in implementing effective, pragmatic and sustainable solutions.

Key responsibilities include (but may not be limited to):

• Supporting and maintaining site compliance with BS EN ISO 22716 Cosmetics GMP, the site Quality Management System and relevant Company standards
• Reviewing executed batch manufacturing records and associated documentation to support the timely release of products
• Completing QA disposition and release activities for raw materials, intermediates and finished products, in accordance with approved procedures and delegated authority
• Reviewing and approving master batch records, specifications and other controlled quality documentation
• Drafting, reviewing, approving and maintaining Controlled documents (SOPs, policies, work instructions, forms, specifications, quality records, etc) ensuring they remain accurate, effective and up to date
• Taking ownership of elements of the Quality Management System (including training and system maintenance), and helping to ensure that processes are consistently followed and effectively maintained, for example:
• Leading or supporting investigations into deviations, non-conformances, customer complaints and other quality events;
• Coordinating CAPA’s, including root-cause analysis, action follow-up and effectiveness checks;
• Managing change-control activities and ensuring that proposed changes are appropriately assessed, documented, approved and implemented;
• Development to site SME for QMS systems and acting as a trusted point of contact for colleagues across the site
• Extensive involvement in all audit processes, including:
• Planning and conducting internal audits
• Supporting the supplier audit programme
• Supporting customer, certification and other external audits
• Managing and maintaining Quality Assurance Agreements with customers, suppliers and other relevant third parties
• Monitoring Quality KPIs and identifying recurring issues, emerging risks and opportunities for improvement
• Providing quality-system (and related) guidance and training to colleagues and helping to build understanding of individual quality responsibilities
• Preparing and presenting quality reports, metrics and trend analyses for site and Group stakeholders, providing clear insight into quality performance, compliance risks, CAPA progress and improvement priorities.
• Working collaboratively with SHE, HR, Production, Process Research and Development, Engineering, and other functions, to embed quality into day-to-day operations and new or changing processes
• Supporting or leading Quality related and appropriate Safety, Health and Environmental (SHE) initiatives, applying sound chemical and process-safety awareness when reviewing quality issues and operational changes

What we're looking for

We are looking for an experienced Quality Assurance professional who combines sound scientific understanding with practical experience of quality systems in a manufacturing or similarly regulated environment.

You will ideally bring:

Essential experience and knowledge

• Approximately five years’ relevant Quality Assurance experience, preferably gained within chemical manufacturing, cosmetics, pharmaceutical starting materials, speciality chemicals or another regulated manufacturing environment, including experience of: deviations, non-conformances, change control, complaints, root-cause investigations, CAPA, audits, document control (review and production), batch records, quality records and reporting,
• A degree, HNC, HND or equivalent higher-level qualification in chemistry, pharmaceutical science or another relevant scientific discipline, or comparable knowledge gained through substantial industry experience
• Experience of planning for and supporting internal, external, customer or supplier audits, and following resulting actions through to completion (at minimum, must have Internal audit experience, external audit experience is preferable)
• Strong practical experience of working within and maintaining a Quality Management System
• The ability to assess quality and compliance risks, make sound evidence-based decisions and escal…
• Strong written and verbal communication skills, with the confidence to explain Quality requirements clearly and constructively to colleagues at different levels and across different functions
• Excellent attention to detail, organisation and time management, with the ability to manage competing priorities without compromising quality
• A proactive and collaborative approach, with the ability to work independently while contributing positively to the wider team
• A practical awareness of chemical and process safety within a chemical manufacturing environment
• Experience of supporting or leading Safety, Health and Environmental (SHE) improvement activities
• A genuine commitment to continuous improvement and to building a culture in which quality is understood as everyone’s responsibility

Desirable experience and qualifications

• Working knowledge of BS EN ISO 22716 Cosmetics GMP, or experience of Regulated Starting Material Experience or a comparable regulated manufacturing standard
• Experience of Lean, Six Sigma or another structured problem-solving or continuous-improvement methodology
• A NEBOSH General Certificate, IOSH Managing Safely qualification or comparable Health and Safety training
• Experience of mentoring colleagues or providing training on quality systems and procedures
• Pharmaceutical experience is not essential. We welcome applications from candidates who can demonstrate strong, transferable Quality Assurance experience gained in cosmetics, chemicals or another suitably regulated manufacturing environment.

Search Terms:

Senior Quality Assurance Specialist | Senior QA Officer | Senior Quality Systems Specialist | Senior QA Chemist | Quality Assurance Specialist

Why CARBOGEN AMCIS?

This is an opportunity to become part of a business where quality, safety and innovation is at the heart of everything we do. You'll work alongside experienced scientists and technical specialists, gain exposure to a diverse range of projects, and play an important role in delivering a wide range of products and services that make a real difference to our customers.You’ll have the opportunity to make a real contribution to our local site, whilst having the benefit of being part of an International organisation.

Our Company vision is to bring science to life by providing innovative solutions in products and services, contributing to the well-being of people and the planet.

If you are committed to quality and ready for your next challenge, we'd love to hear from you.

Why Join Us?

At CGAM, we recognise that our colleagues are our greatest asset. In addition to a rewarding and varied role, you'll benefit from a comprehensive package designed to support your financial wellbeing, health, career development and work-life balance.

6% employer contribution pension, free parking, free on site gym and other wellbeing benefits, private health and life insurance cover, free travel insurance, discounted retail vouchers, a wide range of salary sacrifice options (with Mintago), Employee Assistance Programme (EAP) and access other external support options 24/7, including access to Financial Advisors and financial wellbeing tools, a broad selection of training and development opportunities, colleague recognition scheme and 'jubilee' rewards, colleague social events and CSR activities, plus a great workplace environment, a collaborative culture, and a range of other benefits.

Our people make the difference. We're proud of our supportive culture, commitment to wellbeing, and focus on helping colleagues develop and succeed. If you're looking for a role where your scientific expertise will be valued and your contribution recognised.

• CARBOGEN AMCIS is a leading service provider in the area of product and process development, including the commercial production of active ingredients for the pharmaceutical and biopharmaceutical industries. We have 4 facilities across Switzerland (Aarau, Hunzenschwil, Bubendorf, and Vionnaz), as well as locations in St-Beauzire (FR), Manchester (UK), Shanghai (CN) and Veenendaal (NL). Our success is based on the high professional and personal competence of our employees. Learn more about careers opportunities at CARBOGEN AMCIS at: www.carbogen-amcis.com/careers